Medical Design & Outsourcing – JANUARY 2023

MOVE OVER BABY BOOMERS, FORMER MEDTRONIC CEO BILL GEORGE SAYS

MOVE OVER BABY BOOMERS, FORMER MEDTRONIC CEO BILL GEORGE SAYS

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EDITORIAL STAFF

EDITORIAL

Executive Editor

Chris Newmarker cnewmarker@wtwhmedia.com @newmarker

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Jim Hammerand jhammerand@wtwhmedia.com

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Associate Editor Sean Whooley swhooley@wtwhmedia.com @SeanWhooleyWTWH

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DeviceTalks Tuesdays is a weekly virtual event that brings the insights and energy of our in-person events to your desktop.

Each DeviceTalks Tuesday will kick off with a quick briefing from the editors of MassDevice and Medical Design and Outsourcing. These presentations will give attendees insights on what trends will be moving medtech in the days to come.

Be sure to check back frequently as new live events continue to be added.

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Courage to lead – and leap

It’s been a privilege to edit the latest edition of Medical Design & Outsourcing, kicking off 2023 with our annual Leadership in Medical Technology Issue.

Executive Chris Newmarker had the honor last year, as I was on paternity leave with my newborn son. Baby James is now a fearless 1-year-old on the move, scrambling his way to new heights on anything he can climb and terrorizing our toddler and the family dog.

His first steps are days away. He’s just started to stand on his own for a few seconds at a time. One of two actions usually follows this two-footed feat. Most times, he plops down to the floor on his diaper-cushioned rear. But increasingly often, he’ll lunge forward with no guarantee that he’ll land on his feet or someone will catch him as he falls.

There will be bumps, bruises and boohooing before this baby’s bipedal breakthrough. But I know he’ll do it. Somehow, so does he. I hope he holds on to that courage.

Courage is a word that kept coming to me while listening to Outset Medical CEO Leslie Trigg speak on stage at our DeviceTalks West conference. She spoke of the importance of leaping before you look, taking risks and believing in yourself and your team.

Trigg is on the cover of this Leadership edition because she’s led the device developer through key design decisions and into the homes of dialysis patients across the country. When the call came to become CEO, she wasn’t sure it was the right move for her or for the company. But she had faith in the team, in the technology, in herself, and she took that leap.

Medtech legend Bill George is also featured in this edition, and he’s asking the industry to have the courage to hand the keys to the next generation. He wants today’s leaders to embrace change and prepare tomorrow’s leaders on their terms. “Give them the leadership roles, and you’ll be shocked at how well they perform,” he told Associate Editor Sean Whooley.

You’ll notice more CEOs than usual in our cast of contributors, including MasterControl’s Jon Beckstrand. Fresh off a Series A fundraise that values the quality management system software developer at $1.3 billion, Beckstrand shares what he’s learned about empowering leadership across a fast-growing organization.

This issue also has advice for the next generation from senior executives at Stryker, Johnson & Johnson and Medtronic. “You have to be willing to run to the fire,” Boston Scientific CEO Michael Mahoney tells Tom Salemi in our DeviceTalks column.

As I watch my children grow, I believe more and more that we’re all born with the courage to leap and lead, and that life experiences either erode or build that trait. I hope you’ll draw courage from this Medical Design & Outsourcing Leadership Issue and carry it with you through whatever the year ahead may bring.

Jim Hammerand | Managing Editor | Medical Design & Outsourcing | jhammerand@wtwhmedia.com |

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OLSON

JON BECKSTRAND is responsible for the overall direction and vision of MasterControl as CEO. He drives the company's push for innovation, and advances its position as a leading provider of quality management software and manufacturing execution systems for regulated companies.

MITCH JOHNSON is senior director of research and development at Intricon, a joint development manufacturer of micromedical components, subassemblies and final devices. Intricon is a partner to leading medical device OEMs by designing, developing, engineering, manufacturing, packaging and distributing micromedical products for high-growth medical markets, such as diabetes, peripheral vascular, interventional pulmonology, electrophysiology, wearable biosensors and hearing healthcare.

ELIZABETH NORWOOD is a senior chemist at MicroCare, which offers precision cleaning solutions. She researches, develops and tests cleaning-related products, and has one patent issued and two pending for her work. Norwood has been in the industry for more than 25 years and holds a B.S. in chemistry from the University of St. Joseph.

JIM OLSON is the CEO of Flywheel, a biomedical research informatics platform that leverages the power of cloud-scale computing infrastructure to address the increasing complexity of modern computational science and machine learning.

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COLUMNS

HERE’S WHAT WE SEE: Courage to lead CONTRIBUTORS

COMPONENTS: Bacteria-based biobattery could power devices in the small intestine MANUFACTURING: How medical device manufacturers can ensure cleanliness with the correct process MOLDING: How this medtech molder is navigating challenging times

ORTHOPEDICS: Irish researchers think their new material could enable better spinal cord repair PHARMA: Assurea’s co-founder is on a mission to elevate women in pharma

PRODUCT DEVELOPMENT AND DESIGN: • 6 power management considerations for developing and scaling smaller, smarter micromedical devices • Titan Medical shows off Enos surgical robot’s next-gen design SOFTWARE: 7 imaging data management strategies to accelerate medical device innovation STANDARDS: The next step for medtech: becoming a Google-like leadership proving ground

TUBING TALKS: Why Affera’s cardiac ablation technology is worth $1B to Medtronic DEVICETALKS: 5 tips from medtech leaders for the next generation AD INDEX

OUTSET MEDICAL CEO LESLIE TRIGG AND THE BEGINNER’S MINDSET

The home dialysis developer’s CEO discusses leadership, leaping before you look and making medtech for the

home and hospital.

MOVE OVER BABY BOOMERS, FORMER MEDTRONIC CEO BILL

GEORGE SAYS

The medtech veteran offers his advice for leaders in the industry — and how to make opportunities for aspiring leaders to rise.

MEDTECH’S BIGGEST PERSONNEL MOVES

OF 2022 Hired, fired and retired — Medtech leaders at some of the industry’s largest companies made news with big moves, including surprising exits and well-earned promotions.

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Bacteria-based biobattery could power devices in the small intestine

This biobattery could power ingestible cameras in the small intestine.

Their solution builds on Choi’s past research utilizing bacteria to create low levels of electricity that can power sensors and Wi-Fi connections. They say other options, like potentially harmful traditional batteries, are less viable. Wireless power transfer from outside the body is inefficient, they said, while temperature differences can’t harness thermal energy and intestinal movement is too slow for mechanical energy.

Researchers at Binghamton University think they have developed a solution for powering ingestible cameras in the small intestine.

They believe they can power devices in the hard-to-reach digestive organ, which winds around the human gut for an average of 22 feet.

Instead, the biobattery uses microbial fuel cells with spore-forming Bacillus subtilis bacteria. They remain inert until they reach the small intestine, the researchers said.

Sean Whooley Associate Editor

“There are some regions in the small intestine that are not reachable, and that is why ingestible cameras have been developed to solve this issue,” professor Seokheun “Sean” Choi said in a post on the university’s website. “They can do many things, such as imaging and physical sensing, even drug delivery. The problem is power. So far, the electronics are using primary batteries that have a finite energy budget and cannot function for the long term.”

Choi is a faculty member in the Department of Electrical and Computer Engineering at the Thomas J. Watson College of Engineering and Applied Science. Choi led a team of Ph.D. students, including Maryam Rezaie and Zahra Rafi ee. Together, they published their fi ndings in Advanced Energy Materials .

The technology utilizes a pH-sensitive membrane that requires certain conditions to activate. It only works in the small intestine, based on the pH levels, as the stomach has very acidic pH, Choi said.

While some may not be keen on the idea of ingesting bacteria, Choi explained that bodies contain nontoxic microbes that help with digestion and other functions. (continued on page 16)

The ingestible devices could help physicians see into otherwise unreachable parts of the digestive system.

Image courtesy of Binghamton University

“There are some regions in the small intestine that are not reachable, and that is why ingestible cameras have been developed to solve this issue.”

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(continued from page 14)

“We use these spores as a dormant, storable biocatalyst,” he said. “The spores can be germinated when the nutrients are available, and they can resume vegetative life and generate the power.”

Looking ahead, Choi and the team plan to improve the capsule-sized biobattery. For instance, it tends to take up to an hour to germinate completely once it reaches the small intestine. They aim to make that faster.

The cell generates around 100 microwatts per square centimeter of power density. That represents enough for wireless transmission, but the researchers hope to make it 10 times more powerful.

Such batteries would also require animal and human testing, along with biocompatibility studies.

“I believe that our micro-fuel cell has a huge potential, but we have a long way to go,” Choi said.

Binghamton University professor Seokheun "Sean" Choi

“I believe that our micro-fuel cell has a huge potential, but we have a long way to go.”

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Cleaning is an essential process in the production of medical devices and equipment. It helps ensure parts meet quality and validation standards, but also helps guarantee device reliability.

When it comes time for medical parts manufacturers to upgrade their cleaning methods, it’s important to do some legwork before purchasing any cleaning fluids or vapor degreaser cleaning equipment. Without proper planning,

you might find yourself with a new — and expensive — piece of cleaning equipment but no compatible cleaning fluid or method to get the job done.

To avoid this dilemma, three questions need to be answered first.

1. What is the contamination? Knowing the type of contamination helps narrow down your cleaning fluid selection.

Medical device parts contamination encompasses a number of production soils, including hydrocarbon-based stamping oils, machining lubricants, corrosion protection agents and metal shavings. They also include more stubborn soils like solder fluxes, silicone oils, synthetic greases, grinding media, polishing pastes, baked-on resins, inks, heavy pitches and thick waxes.

(continued on page 20)

Elizabeth Norwood | MicroCare |

Modern solvent-based fluids are hostile to bioburden and don’t harbor pyrogens. Photo courtesy of MicroCare

Vapor degreasing is a consistent, repeatable process that is easy to validate and is cleanroom compatible.

Images courtesy of MicroCare

(continued from page 18)

2. What cleaning process should be used? When vapor degreaser cleaning, the parts contamination also helps determine which cleaning method to use.

Mono-solvent vapor degreasing uses a single cleaning fluid inside a traditional two-sump vapor degreaser. It is ideal for removing light to moderate soils. Parts are cleaned in the boil sump, rinsed in the rinse sump and dried in the vapor blanket above the two sumps.

Some mono-solvents are also azeotropes, a cleaning fluid made with two or more components that combine to form a stable mixture. They do not separate and always behave as one solvent, even during boiling, cooling and distillation. Azeotropes help increase a fluid’s cleaning performance, make it nonflammable or improve its toxicity profile. They boast the cleaning performance and safety of a mixture of cleaning solvents but are easier to store, handle and dispose of.

Co-solvent vapor degreasing delivers the speed and convenience of mono-solvent cleaning but uses two solvents for more cleaning power. A very high temperature boiling fluid in one sump and much lower boiling temperature fluid in another work together to boost cleaning performance. The vapor degreaser can also be outfitted with sprayers, super-heat, ultrasonics and other add-on accessories to enhance cleaning performance. Cosolvent vapor degreasing is ideal for removing more stubborn soils.

Bi-solvent vapor degreasing is ideal for cleaning tenacious soils. Bisolvent cleaning uses a two-sump vapor degreaser and a separate preliminary cleaning tank. The solvating fl uid is in the preliminary cleaning tank outside of the vapor degreaser. It boils at much higher temperature than the rinsing fl uid in the two rinsing sumps inside the vapor degreaser.

TOP: Mono-solvent vapor degreasing uses a single cleaning fluid inside a traditional two-sump vapor degreaser.

BOTTOM: Bi-solvent vapor degreasing uses two solvents for more cleaning power. Image courtesy of MicroCare

Warning: Proceed with caution when opting for a co-solvent or bisolvent vapor degreasing cleaning method. Not all medical device parts require these more aggressive, hightemperature cleaning methods. Using a very powerful co-solvent or bi-solvent could damage delicate substrates, especially the acrylic, ABS and polycarbonate commonly used in many medical devices and parts.

3. What is the best cleaning fluid to use?

Environmental regulations should also guide cleaning engineers on which vapor degreasing fluid is the right one use. It must meet local, state or federal regulatory requirements.

For example, commonly used nPB (n-Propyl Bromide) and TCE (trichloroethylene) are either banned or under scrutiny in many countries due to air and water quality concerns. This means that these cleaning fluids will likely need to be replaced with better alternatives soon and should probably be avoided.

Fortunately, a number of effective cleaning fluids on the market today boast zero ODP (ozone-depleting potential) and low GWP (global warming potential) ratings to meet increasingly stringent environmental regulations.

Stay bioburden-free

No matter which vapor degreasing fluid or method a cleaning engineer chooses they can rest assured that the modern solvent-based fluids are hostile to bioburden and don’t harbor pyrogens. Vapor degreasing with solvents does not use water, which helps maintain an environment free of bacteria, viruses, or other pathogens. It is also a convenient way to validate a cleanroom-compatible, bioburden-free cleaning process.

Choose the fluid, then the vapor degreaser

It is important for the cleaning engineer to first understand the type of contamination and which vapor degreasing method and fluid will best remove it. Then, armed with this information, they can choose the appropriate vapor degreasing equipment and accessories.

For example, if a cleaning engineer purchases a vapor degreaser designed for mono-solvent cleaning only, the machine doesn’t allow for options. If the monosolvent cleaning process is ineffective on their contaminant, then the engineer is left with soiled parts and an expensive vapor degreaser they can’t use.

(continued on page 25)

TOP: Cleaning test labs perform cleaning trials on dirty parts.

BOTTOM: Vapor degreasing is ideal for cleaning medical device internal circuit boards. Photos courtesy of MicroCare

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(continued from page 22)

Rely on the experts

Fluid suppliers often have cleaning test labs for cleaning trials on dirty parts to determine the contaminant type and recommend if the mono-solvent, bisolvent or co-solvent cleaning process will work best. The testing also helps determine if special vapor degreaser addons or modifications might be necessary to get the specified level of clean.

When deciding how to clean medical devices and parts, choose the cleaning fluid first. Understanding the soils encountered, the cleaning method needed and expected cleaning outcomes up front helps medical device manufacturers know which cleaning fluid to choose and ultimately which vapor degreaser features are required.

Solvent-based vapor degreasing removes production soils. Photo courtesy of MicroCare

How this medtech molder is navigating challenging times

5 questions with Westfall Technik CEO Mark Gomulka

Mark Gomulka has had a busy first year as CEO of plastics contract manufacturer Westfall Technik. Gomulka joined Las Vegas–based Westfall Technik in September 2021 after five years at Flex and 15 years at Nypro before that.

Formed in 2017 with 20 acquisitions closed and more on the way, the endto-end plastics manufacturer’s revenue is now around $400 million per year with approximately 20% year-over-year sales growth, Gomulka said.

“I’m having fun doing this because I think we’re creating something,” Gomulka said in an interview. “We have 2,500 employees. That means we serve 2,500 families. And most importantly, we have incredible customers that took a gamble on us and continue to take a gamble on a company that five years ago did not exist. ... We’re a single-source provider to the next-generation insulin pump. That’s going to change people’s lives.”

The following has been edited for clarity and space.

MDO: What did you learn in your first year as CEO?

Gomulka: It definitely was an interesting year to become CEO. We saw some unprecedented shortages of raw materials. It was a bidding war. Who’s going to stay? Who’s going to have the materials to run products for our customers? There’s no better way to prove yourself and how resolute you are than in times like that. We saw inflation faster than the average consumer. We saw it coming. We are early indicators. Contract manufacturers see what raw materials are doing, what conversion rates are doing, what labor rates are doing, shortages of labor. And we had to revamp almost our entire operational strategy to deal with this.

One of the things that I’ve learned: (continued on page 28)

Photo courtesy of Westfall Technik

Westfall Technik CEO Mark Gomulka

(continued from page 26)

You have to surround yourself with fantastic people. I think I’ve done that pretty well, between Merritt Williams on the commercial side and Chief Procurement Officer Dave Schultz — he’s a nine-year executive from CONMED and he used to be my customer back when I was at Nypro. We built out our engineering team, especially tooling, focusing on medical. Cause we’re seeing a lot of momentum when it comes to devices, true devices. Not something that’s been around for 10, 15 years. I’m talking about devices that really improve patients’ lives from outpatient to in-home care. Wearable autoinjectors, insulin pumps, stuff that’s not even on the market yet.

MDO: Are we out of the woods on resin shortages?

Gomulka: It’s improving. It’s definitely improving on the commodity grades, no question about it. There’s still some pressures, especially around medical grades like nylon, nylon 6 and polycarbonate, certain grades and some custom compounding ones. There are still some shortages of components that go into it. But for the most part, I think it’s going to start stabilizing. And it’s also helping that the entire other industries around us are stabilizing, meaning they have inventories. Demand is dropping a little bit while they have really improved their capacities. There’s a lot more polypropylene capacity. There’s a lot more other capacities that were installed since 2021 that’s helping us. What you’re going to see is — I don’t want to call it an artificial decline in sales when materials start stabilizing and polypropylene goes from $1.50 to 50 cents, or certain grades go from $10 back to $5 — but you’re going to see that natural reversal. (continued on page 31)

“One of the things that I’ve learned: You have to surround yourself with fantastic people. I think I’ve done that pretty well.”

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(continued from page 28)

We look at value-add outside of materials. So we’re growing value-add year over year. I’m trying to keep the material noise out of it. I’m not a speculator. If I was, I wouldn’t be running a molding company. I’d probably be sitting on Wall Street somewhere. So that’s what we’re seeing, barring another Ukraine situation or something like that.

MDO: What trends do you expect in device manufacturing?

Gomulka: People are going to start planning a little bit more when it comes to capacities and surge capacities, especially on the device side. [Diabetes device makers, for example, are] governed by one thing — their ability to provide patients with their devices and there’s not enough. They’re not even scratching what the market needs with what they can build at a sustainable rate. Libre has a 14-day wearable. Every patient that’s installed has X amount per year. If the world capacity is 115 >>

Photo courtesy of Westfall Technik

million for Libre, you can only serve so many patients. Diabetes is not going away, and we’re only talking about western countries. Think about India and China. The world does not have enough capacity to make those devices and there’s not enough sterilization capacity in the world for all those devices. Devices are the future, from surgeries to wearables, everything’s getting smart, getting miniaturized. And it’s getting mass-produced. Those who can embrace how you’re going to do it a little bit differently and provide truly, totally vertically integrated solutions, including items like sterilization, are the ones who are doing to create a lot of change in this industry.

MDO: What’s different about Westfall Technik?

Gomulka: We pride ourselves in having a lot of differentiating technologies, especially in micromolding, which is incredibly important to med devices. Because everything’s getting smaller, wearable. We built our own micromolding machine, eliminating the need for runners. We pioneer how we process bioabsorbable materials, implantable materials and things like that. We have a platform that’s finally getting the attention of a lot of the OEMs, solving a lot of issues for the Abbotts, the Hologics, the Medtronics. If I can eliminate 90% of the waste that comes out of the product stream, I don’t compete on price.

MDO: How do you hold it all together as CEO when rolling up so many companies?

Gomulka: What’s the secret of acquiring 18 companies in 18 months, or 20 companies in 24 months? Zero secrets. You write checks. The secret is how you integrate and who you surround yourself with. There are phenomenal CEOs, COOs, general managers that enter a company that’s already been established. I like to say, the roads are paved, stop signs are up, stoplights are up, the lanes and traffic patterns are defined. They go in and they do a phenomenal job running those companies. It takes a different person to actually pave the roads, stripe the roads, put stop signs up, stop lights up and everything else, and create one company system, creating one company culture, creating commonality and even as simple as design software. That’s where the fun is and the last 20 years of my career, that’s what I did. Everybody who works in this organization on my team has a passion for growing a business like nobody has seen before. Is it easy? Absolutely not. Are we perfect? Hell no. We will trip more often than not, but the one who gets up first and continues running is the one that wins. Because we learn from the mistakes as we go along. It’s been a phenomenal ride.

“We pride ourselves in having a lot of differentiating technologies, especially in micromolding, which is incredibly important to med devices.”

Flexan is a global contract manufacturer of custom high-quality silicone and thermoplastic components, sub-assemblies and devices. For over 75 years, Flexan has been trusted to deliver custom contract manufacturing solutions and high-quality products. Flexan invests in innovation, talent, and infrastructure to provide end-to-end manufacturing services and solutions across the supply chain utilizing the best technical expertise in the industry.

Sean Whooley Associate Editor

Researchers have developed new PEDOT nanoparticles to promote neuronal repair and regeneration after a spinal cord injury.

Image courtesy of University of Limerick

New material could improve spinal cord repair

Researchers at the University of Limerick in Ireland shared research demonstrating progress in spinal cord tissue repair.

University of Limerick researchers recently reported a new advance in spinal cord tissue repair that could help patients recover from injuries.

The researchers, who conducted their work at UL’s Bernal Institute, said they have developed new hybrid biomaterials. They published their findings in Biomaterials Research, saying they turned to nanoparticles built on existing practices in tissue engineering. As a result, they successfully synthesized the materials to promote repair and regeneration following spinal cord injury.

Maurice Collins, associate professor of the School of Engineering at UL, led the team along with lead author Aleksandra Serafin, a Ph.D. candidate at UL. Their research used a new kind of scaffolding material and a unique new electrically conducting polymer composite. This promoted new tissue growth and generation.

“Spinal Cord Injury remains one of the most debilitating traumatic injuries a person can sustain during their lifetime, affecting every aspect of the person’s life,” said Collins. “As there is currently no widely available treatment, continuous research into this field is crucial to find a treatment to improve the patient’s quality of life, with the research field turning towards tissue engineering for novel treatment strategies.”

The team cited growing interest in electroconductive tissue-engineered scaffolds. This emerged as a result of improved cell growth and proliferation from exposure to a conductive scaffold.

Serafin said limitations exist with the PEDOT:PSS commercially available polymer in biomedical applications. That polymer relies on the PSS component to allow for water solubility. When implanted in the body, though, it displays poor biocompatibility.

(continued on page 36)

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Our ONE Westfall integrated operating model is disrupting the market offering a customer-centric solution set with a single point of accountability. And we are recognized as the lowest risk medical product development supplier among all third-party manufacturers as required by ISO 13485 and FDA.

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(continued from page 34)

“This means that upon exposure to this polymer, the body has potential toxic or immunological responses, which are not ideal in an already damaged tissue which we are trying to regenerate,” said Serafi n. “This severely limits which hydrogel components can be successfully incorporated to create conductive scaffolds.”

Overcoming limitations

The researchers developed novel PEDOT nanoparticles (NPs) to overcome that limitation. Synthesis of these NPs allows for the tailored modification of the surface of the NPs. The approach helps achieve the desired cell response. This increases the variability of which hydrogel components may be incorporated.

“The introduction of the PEDOT NPs into the biomaterial increased the conductivity of samples,” the researchers said. “In addition, the mechanical properties of implanted materials should mimic the tissue of interest in tissue-engineered strategies, with the developed PEDOT NP scaffolds matching the mechanical values of the native spinal cord.”

Researchers evaluated the biological response of these NPs with stem cells invitro and in animal models of spinal cord injury in-vivo. They observed “excellent” stem cell attachment and growth on the scaffolds. These tests also demonstrated greater axonal cell migration toward the site of spinal cord injury and lower levels of scarring and inflammation compared to the injury model which had no scaffold. (continued on page 39)

“As there is currently no widely available treatment, continuous research into this field is crucial to find a treatment to improve the patient’s quality of life, with the research field turning towards tissue engineering for novel treatment strategies.”

(continued from page 36)

“These results offer encouraging prospects for patients and further research into this area is planned, said Serafin. “Studies have shown that the excitability threshold of motor neurons on the distal end of a spinal cord injury tends to be higher. A future project will further improve the scaffold design and create conductivity gradients in the scaffold, with the conductivity increasing towards the distal end of the lesion to further stimulate neurons to regenerate.”

The Irish Research Council funded the project in partnership with Johnson & Johnson. The Irish Fulbright Association contributed by enabling a research exchange to the University of California, San Diego. Faculty at the UL Science and Engineering and Health Research Institute also provided support.

Assurea’s co-founder is on a mission to elevate women in pharma

Tanya Sharma is the co-founder of Assurea, a consulting firm that helps startups in cell and gene therapy, biotech, and food tech implement quality compliance frameworks.

Within life sciences, the Raleigh, North Carolina-based company helps clients move from clinical to commercial, or preclinical to clinical phases of product development.

“We help clients navigate regulatory requirements,” Sharma said.

Sharma is also an advocate for women in STEM and the life sciences. To that end, she is closely involved in the Women in Pharma initiative from the International Society for Pharmaceutical Engineering.

In the following interview, Sharma touches on her work encouraging diversity in Assurea and beyond and the importance of culture in life sciences organizations.

Read more from Sharma and others in our Women in Pharma and Biotech series at wtwh.me/wipb

MDO: How much progress has been made in acknowledging and promoting women’s contributions in the life sciences?

Sharma: It’s progressed signifi cantly when it comes to communities that provide a platform for women to have access to mentorship, coaching and networks to advance their careers. Being in a community that understands the context of what you are doing builds optimism and encouragement for any challenges that we face.

There is still a lot of room to endorse women for their contributions and accomplishments. There are several pockets within the life sciences, such as in the C-suite, entrepreneurship and emerging technologies, where we need an equal platform and diversity of thought. We can do that by being aware, encouraging women and being inclusive.

(continued on page 42)

Brian Buntz | Pharma Editor |

There is still room for improvement to empower women in several areas within the life sciences.

Photo courtesy of Adobe Stock

(continued from page 40)

I strongly believe that we need more people rooting for each other to create a ripple effect of empowerment.

MDO: How can diversity promote innovation in pharma?

Sharma: In the pharma industry, we support many companies implementing new technologies, such as blockchain use cases.

I participate in pilots that are implementing blockchain technology as a platform for track-and-trace for drug products across the supply chain. That is an entirely new concept and one for which there is a limited amount of data available, so it requires substantially more creative thinking.

Diversity is important as both internal and external considerations for pharma companies. Another critical aspect is that pharma companies should ensure that clinical trials are more geographically dispersed. Patients in Asia or Africa should also have a voice in clinical trials.

Being a woman of color in a startup,

it is important to me to break the barriers for others who are similar. I want to communicate my story as I believe there is so much power and influence in sharing my experiences to help guide other women to accept opportunities that might not even have been considered an option in the past.

MDO: What has the most significant leadership challenge of your career been, and how did you overcome it?

Sharma: One of the biggest challenges relates to feedback. If you are creating something new, you’ll ask for and obtain feedback. Some of the advice you receive might be more conducive to what you’re

doing, and some of it won’t be. But how do you navigate those opinions, identify what will work and what won’t, and what to do with it all? What is your decision-making process when it comes to feedback?

That was one of the leadership challenges when starting Assurea because ours was such a new model. We overcame this challenge by field testing our model iteratively and hearing the customers’ voice early on. In our company, once we have 70% of data, we move forward, and even if it is a wrong decision, we know we have time to figure out any mistake and fix it.

MDO: How do you help clients with technological challenges?

Sharma: We help create and build frameworks for areas where there is not a lot of regulatory clarity, such as point of care with hospitals, platform-focused activities or clients that are implementing emerging technologies to integrate labs or their end-to-end supply chains.

(continued on page 45)

“Diversity is important as both internal and external considerations for pharma companies.”

(continued from page 42)

We have supported several clients including Moderna, successfully building sustainable quality compliance frameworks.

MDO: What is the most important lesson you’ve learned that has guided your career?

Sharma: When growing a team, it is imperative to continue to have a missionfocused culture. That was the biggest learning at Assurea. We are growing and are always hiring, but some people do not align with our values. And it’s hard when someone is not aligned with your values, but they’re technically a good candidate for your clients. That was an important lesson for us — we must continue to focus on creating and building the culture we know will be best within Assurea.

MDO: Do you have a perspective on ways to encourage more young women to enter STEM and life sciences?

Sharma: It depends on where they are in the world and the market needs. In some countries, a lot of women are in STEM, but it can be difficult to advance in those areas. Everything starts in the school systems and one’s education. Following college graduation, one might not have exposure to different potential options in STEM. It is tough to backtrack, especially if student loans are involved. But the root of it is in the school system and having an educational program that encourages involvement in STEM. There could be after-school programs or collaboration opportunities with companies that share various aspects of what it means to have a career in STEM. That’s probably the best way to get more young women into STEM.

To keep people in the STEM field, participation in accelerator programs and leadership workshops are critical to develop exposure and awareness for both men and women. Some women’s organizations are not as inclusive to men. But to make a real difference, everyone must be included.

It’s good to know where you come from. At Nitto Kohki, we come from a line of engineers and businessmen dedicated to exceptional manufacturing execution. In our line of vacuum and pressure pumps, this is seen in the unique linear-piston design, where one moving part resolves to exceptional reliability, low vibration and noise, high energy efficiency, and long, consistent performance life (>10,000 hrs.) for a host of critical medical applications. It’s why the medical device industry has specied Nitto pumps for over sixty years— the quality in our DNA. Find out how you can use it to your advantage.

Efficient electrical power management systems drive continued innovation for medical-grade devices such as hearing aids from design engineering through end-of-life disposal or recycling.

Photo courtesy of Intricon

6 power management considerations for developing and scaling smaller, smarter micromedical devices

Supercharge every phase of micromedical device product development with these questions.

Some of the biggest considerations for designing, manufacturing and scaling today’s smaller, smarter medical innovations center on providing power to microelectronic systems. From mechanical functionality to data operations and wireless communications, effective power management drives continued device innovation. Addressing five fundamental issues can help multidisciplinary teams bring new and next-generation medical devices to market on-time and on-budget.

1. Why: The use case

The obvious starting point is documenting the intended use. Why is a product being built and how will it be used? A single-use device for specialized clinical procedures will have different power requirements than reusable biosensors in consumer settings.

Additionally, how long will a device be used — from minutes to years — and is it part of a focused diagnostic protocol or ongoing treatment regimen? All of these factors matter for effective power management.

With market demand accelerating for smaller, smarter devices functioning in networked environments, an engineering mandate now is a growing need for always-on, no-fail wireless communications for supporting secure access to accurate, timely data. Clearly defining the use case for data operations in the earliest stages of R&D is of critical importance.

2.

How: Power supply and power budget

As key use case requirements come into focus, the next step is how the device will be powered. Will it be a single-use device or multi-use with replaceable batteries? Or perhaps the device itself is rechargeable, which is becoming more and more common.

(continued on page 48)

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(continued from page 46)

There are almost always trade-offs. If a device is disposable, it will most likely need to ship fully charged. But if it’s rechargeable, it will either need electromechanical functionality (e.g., pins) or wireless (e.g., inductive, RF, etc.). Replaceable batteries call for battery contacts, access doors and other parts. Battery chemistry and the environmental costs of disposal are topics of increasing importance.

Functionally, a critical consideration is understanding peak current requirements and the expected duration between recharge or replacement and then matching it to supply capability. This is the power budget, normally specified in watts (W). Calculations are in the format of a spreadsheet where input voltage, input current, output voltage, output current, power in and power out are documented for each power stage and electronics load. Typical electronics load components can include power conversion/conditioning, A to D and D to A conversion, digital signal processing, memory, wireless radios, sensors and perhaps output transducers or displays.

Think of a power budget as a swimming pool with a leaking drain and a resupply hose. The pool represents the battery, the resupply hose represents recharging or replacing the battery and the leaky drain represents all the electronic loads. The trick is designing the pool so it’s large enough that the drains last long enough for the intended use, and so the resupply hose is big enough that the pool never empties. Think “balance.”

3. What: Components and board design

The main focus at this stage is control. Do users manually put the device into sleep mode for power conservation, or is there a timer? How do users monitor the battery life, or is that controlled by software?

Onboard wireless technology influences component selection and board design because it’s often one of the biggest parts of the power budget, from start-up to steady state conditions. The power source and power conditioning must be able to supply enough current to fulfill the inrush of current when the circuit starts up, but also handle transient demands in use.

Over the long haul, the power supply must be large enough to last through the entire intended use scenario, but not so large as to result in physical space constraints or excess costs (upfront materials costs as well as end-oflife environmental costs and all the maintenance costs in-between). This mandate could range from minutes or hours to months or even years. (continued on page 51)

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(continued from page 48)

4. When: Now! More data, more ways

Data is the driver. As the medical device market continues to advance, software and firmware are foundational for building stable, secure platforms. Effective power management is the behind-the-scenes safeguard that secures new product acceptance and long-term success.

Consider electrocardiogram (ECG) monitors. Historically they were offline devices that collected and stored data that often took days to review. Even then, it wasn’t uncommon for a lab to receive limited data due to lead connection problems. Today, data analysis occurs in real time through wireless communications. This accelerated timeframe places new demands on power management to accommodate data processing, the displays and cloud connectivity.

5. Where: Materials supply and disposal

There’s no margin for error with a medical device in terms of dependability. It simply has to work — and that goes for supply chains to support high-volume manufacturing.

The effects of COVID on supply chains for medical electronics are still being felt. Everything from components (such as resistors and inductors) to complicated ICs have been in short supply with prices and lead times skyrocketing. Many manufacturers have resorted to stockpiling excess inventory. Product redesign initiatives have necessitated revalidating processes and submitting market clearance documentation to regulatory bodies.

On the downstream end, safe disposal is critical because batteries may contain toxic heavy metals. Recycling is ideal, but uptake is inconsistent and proper handling is difficult to enforce. As a result, it’s important that medical devices are designed with the smallest batteries available that meet the demands of the use case.

6. Who: The partnership accelerant

When power management is at its most efficient it is as invisible as electricity itself. High-performance R&D teams function much the same way, directing the flow of energy capably and smoothly for maximum effect.

Close collaboration with internal colleagues as well as external partners supercharges every phase of development, empowering new breakthroughs in performance as medical devices keep getting even smaller and smarter.

Expanding

production capacity To meet

medical device needs

For over 75 years, MICRO has continually expanded our capabilities in order to provide our customers with the finest in full service Medical Device contract manufacturing.

The latest addition to our global footprint is a newly facilitated 32,000 sq. ft. location in Costa Rica featuring clean room assembly and light manufacturing. This recently added piece of the puzzle will continue to allow us to fulfill our Vision:

Titan Medical shows off Enos surgical robot’s next-gen design

Titan Medical is already working on the second generation of its Enos surgical robot as executives meet with potential buyers of the business.

Among other improvements, Enos 2.0 has a new trick up its sleeve. There is a third instrument arm, compared to the two instrument arms in the first generation.

Toronto-based Titan Medical expects its Enos System to be firstto-market as a single-access, roboticassisted surgical system, the company said in a presentation for investors and potential buyers this month. Titan Medical has not yet filed for regulatory approval of the first generation.

“With the time it takes to bring complex products to market in the regulated medical device industry, you must continuously envision the next generation.” Titan Medical CEO Cary Vance said in a statement.

It’s not a bad way to draw more attention to the technology as Titan Medical explores its strategic options, which could include selling the business

or another big move. (As of the time of publication in late January, there was no deal announcement.)

“Our focus on purpose-driven innovation has always been at the forefront of our work,” Vance said. “We are excited to share our three-arm design that was independently created by Titan and builds upon technologies developed for our twoarm system and those generated under a previously executed and completed development and license agreement, and addresses evolving customer needs in single-access robotic surgery.”

The Enos robotic surgery system’s instruments and features

The Enos system uses a single port to enter a patient’s abdomen through the belly button for gynecological surgical procedures such as hysterectomies. Titan Medical said it has also optimized the system for urological and other general surgical procedures, but is focused on gynecological indications first. (continued on page 54)

Titan Medical’s Enos surgical robotics system has snakearm instruments that deploy through a single incision. An Enos 2.0 prototype (pictured here) makes room for a third instrument arm by eliminating the integrated camera and using the 3-D scope.

courtesy of Titan Medical

Executives meet with strategic buyers as they consider the robotic surgery system’s best path forward.

Photo

Titan Medical said its Enos 2.0 prototype design could incorporate third-party instruments, accessories and digital technologies.

Photo courtesy of Titan Medical

(continued from page 52)

The Enos has a 25 mm cannula that it inserts through the single abdominal incision. The cannula has an integrated 2-D camera and a steerable 3-D endoscope. The integrated camera is used for insertion, pre-operative abdominal exploration and instrument entry. The endoscope works alongside the other instruments. Both cameras have highdefinition resolution and illumination.

In addition to the cameras, the firstgeneration Enos system can fit two multiarticulating instrument arms through the cannula. Enos 2.0 eliminates the integrated 2-D camera to make room for a third instrument arm. The Enos surgical robotics system’s suite of instruments includes:

• Monopolar hooks and shears for dissecting avascular planes and coagulation of small vasculature;

• Hunter and Maryland bipolar dissectors with an electric current that flows from tip to tip to safely seal larger vessels;

• Cold instruments such as the mega needle driver, suture cut, tenaculum, fenestrated and lap clinch effectors.

These instruments have a continuous segment design for a broad range of motion in confined spaces while delivering the force and grip needed for surgical tasks, Titan Medical said. They’re designed for fluid movement and to allow the surgeon to do more work in less time with design features such as a minimally bending radius for enhanced triangulation and enhanced instrument travel along the axis. In addition, the arms are strong enough to retrieve larger organs.

Enos 2.0 presents an “opportunity to incorporate third-party instruments, accessories and digital technologies,” the company said in an investor presentation.

The surgeon workstation has a medical-grade high-definition display screen and a dashboard that illuminates instrument status with interoperative overlays.

The Enos surgical robotics system’s patient cart.

Photo courtesy of Titan Medical

Titan Medical designed the Enos system’s console with a small footprint. It’s compact enough that surgeons don’t need a dedicated operating room to use it. Plus, there are no external moving robotic arms and relatively few independent components, making the robot easier to drape for surgery — and faster to prepare for the next surgery.

Titan Medical’s path to commercializing Enos

Titan Medical executives met with potential buyers of the surgical robotics company in San Francisco this month, timing their meetings for the J.P Morgan Healthcare Conference.

The company did not name individuals or companies with whom they met, but the annual conference brings some of the biggest names to the Bay Area.

Medtronic CEO Geoff Martha, for example, spoke on the first day of the conference. Medtronic has already worked with Titan Medical. Additionally, Medtronic has developed its own surgical robotics system, called Hugo, and is using it in clinical trials.

(continued on page 56)

(continued from page 54)

Titan Medical’s sales pitch touted the value of its IP and its Enos system, saying Titan Medical’s partnership with Medtronic contributed to the secondgeneration prototype.

Titan Medical previously hoped to submit Enos for FDA investigational device exemption (IDE) in mid-2023 and commercialize the robotic surgery system in 2025. The company withdrew its Enos timeline in December when announcing the cost cuts, but said the IDE filing would remain a top priority along with the strategic review.

Titan Medical’s presentation for potential buyers offered a new timeline to market, though the fine print says it’s only for information purposes and doesn’t depict actual target dates.

When the company resumes normal operations, it estimates Enos would need two months for the transfer to

manufacturing and system delivery, eight months for safety and verification testing, 11 months for IDE application, FDA review and IDE study, and five months for the commercial launch.

A 12-month process to obtain CE marking would likely start sometime within the 11-month FDA process, the presentation said.

“We are looking forward to meeting with strategic buyers and investors during the conference week and providing a future view into what a three-arm single access robotic-assisted surgery technology could look like,” Vance said ahead of the meetings.

Watch a video covering the new features of Titan Medical’s Enos 2.0 at wtwh.me/enos2

The Enos surgical robotics system’s surgeon workstation

Photo courtesy of Titan Medical

Titan Medical President and CEO Cary Vance

7 imaging data management strategies to accelerate medical device innovation

Medical device companies have massive amounts of data, but often, imaging data can’t support research and development (R&D) efforts. Here’s how to change that.

Data is the lifeblood of R&D groups at medical device companies. However, unlocking the full potential of your organization’s data assets isn’t straightforward, especially for complex data such as medical imaging.

Medical imaging assets are extremely valuable for R&D efforts, but they are often disorganized and lack consistent labeling. This means that before analysis and/or for machine learning or AI applications, the data needs standardization to make it accessible.

But curating complex medical imaging data poses a major challenge in many organizations. Even after organizing data, existing infrastructure and research processes can continue impeding success, and ultimately time to market.

To speed and scale medical device R&D, organizations must embrace extensible data practices and scalable data management solutions. To make the process easier, here are seven data management tips to help maximize the value of imaging data.

1. Get data out of silos

Information doesn’t add value when it exists in isolation. A data silo occurs when data is not easily discoverable and cannot flow freely between departments, a common situation in life science organizations. In many cases, data may be held in different databases with different structures and storage conventions. A comprehensive data platform can alleviate these issues by centralizing data in a shared repository, with access controls and version history. A well-designed and maintained data platform gives organizations flexibility in data storage, access and use, while giving users more visibility to available assets.

2. Conduct upfront data cleaning and standardization

The complex nature of medical imaging data means that researchers must leverage the assets’ metadata to make them useful for large-scale projects. However, metadata conventions often differ between data sources, devices and practitioners.

(continued on page 60)

Image courtesy of Flywheel

(continued from page 58)

Data scientists can standardize the conventions for an organization, both within the archives and also as newly captured data come in. The standardization may include, but is not limited to, standardized labeling for imaging modalities and/or body parts.

3. Ensure data hygiene practices can work at scale

The data standardization described above is only meaningful if it’s possible to apply it in an automated way at the enterprise level. Manually curating, cataloging and organizing data — even if it’s performed by a trained team adhering to agreedupon standards — is too time-consuming, and still carries the risk of inconsistency. Automating these processes as much as possible can prevent many challenges later.

4. Understand data modalities and associated measures used throughout the organization and ensure automation works for all

Your research teams may use imagebased data such as DICOM and microscopy, time series-based data like electroencephalography, and CSV (commaseparated variable) files or other selfdescribing text-based files in their work. Even when utilizing the same modality, different analysis approaches and output measures may need to be followed or captured. In designing an approach to modernize data management, teams should consider every data modality, data type and associated workflow they can integrate with and apply standardization for all.

5. Ensure you have an adequate volume of diverse data for AI training

The old saying “garbage in, garbage out” is especially true for AI training. Models trained using an inadequate volume of data — or data that doesn’t reflect the diversity of impacting variables such as scanner types or patient population — will likely underperform.

(continued on page 63)

“The old saying ‘garbage in, garbage out’ is especially true for AI training.”

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(continued from page 60)

To prevent this, it’s important to leverage all available data within your enterprise, but you may also look to supplement your own data with publicly available datasets or datasets licensed from collaborators. In either case, the need remains for consistent data curation and utilization of the entire data within validated workfl ows.

6. Leverage cloud-scale resources

Medical imaging data requires vast amounts of storage and computational power. Relying exclusively on on-premise resources can be both costly and limiting. Leveraging cloud-scale resources, on the other hand, allows for elastic compute infrastructure and more flexible storage. Organizations can spin up instances on the cloud as needed for unrivaled scalability.

7. Consider how to address comprehensive provenance

Provenance (establishing a documented trail to the original data source and associated processes and analysis steps) is required for reproducibility and regulatory approval. Research teams should look for systems that can automate provenance, with recording of access logs, versions and processing actions. Automating this work not only removes the burden from researchers but eliminates the risks of noncompliance and errors.

If your organization is facing challenges in leveraging insights from medical imaging data, you’re not alone. Fortunately, there are tools and resources available to automate and scale data capture, curation, and computation.

Incorporating these data management tips comes at an upfront investment of time and resources, but that investment can pay dividends through enriched data and accelerated innovation.

Medical imaging can quickly fill volumes of computer data storage, but the cloud offers options for keeping and using that information. Image courtesy of Flywheel

The next step

for medtech: becoming

a Google-like leadership proving ground

Leadership is crucial for attracting, keeping and getting the most out of great talent.

Medical technology companies are among the leading drivers of innovation around the world, but most organizations are missing a critical element of building for the future. To ensure the creative future of the industry, we need to create intentional programs that will empower the next generation of engineering and business leaders.

The tech giants of Silicon Valley have provided a roadmap for businesses everywhere to follow. Former Google employees, for example, have created more than 170 startups, including Pinterest, AirTable, Nuro and others.

Much of this second-generation success is directly attributable to the Googles and Metas of the world creating formal, quality leadership training programs. These are typically built into their cultures, and medtech companies need to adopt a similar strategy en masse.

Building and training emerging leaders is a core responsibility of highlevel leadership. In my 20 years as a CEO, my role has shifted from direct leadership to building leaders within our company. At MasterControl, we made deliberate changes in our organizational structure to cultivate those leadership skills and encourage innovation from everyone.

Here is a path companies can follow as they look to build for the future:

Make leadership a part of your identity

The importance of training future leaders became clear to me during an annual kickoff meeting a few years ago. We were in a phase of rapid growth, and as I stood to address the team, I realized that of our 500 employees, at least 150 were new.

There was a point during our startup phase when I knew every person and understood their work styles.

(continued on page 66)

MasterControl CEO

Jon Beckstrand and Chief Culture Officer Alicia Garcia at the 2022 MasterControl Summit

Photo by Austen Diamond Photography

STANDARDS

(continued from page 64)

When we hit around 300 employees, I realized that our team was too large for me to personally know each team member. But at this annual kickoff, something was concerning me. Not only did I lack a personal relationship with the new team members, but I did not know many of their managers, either. I was not confident that each new employee would experience a consistent and positive leadership culture. And I knew that without good leaders at the various levels throughout the organization, it would be hard to maintain collaboration, function as productive teams and retain talent.

We started what has become our leadership program shortly after. We have learned there are great benefits to having strong leaders throughout an organization and that poor leadership creates a significant drag on productivity. We have come to understand that creating a distinct leadership brand is incredibly

important, not only for operational success but also for recruiting and keeping great talent.

In the same way that a company focuses on branding and image when it comes to products and services, smart organizations also need to shape their leadership brand. During that fateful meeting, I knew what we had to do. If we were going to attract the talent that will build our company now and in the future, we had to make leadership a part of our identity.

Create excellent resources for training and support

The first step of our leadership journey was drafting a carefully considered statement of what an employee should expect from leaders at the company. This document became a guide for developing a five-point leadership code that informs our culture at all levels of the company.

The five pillars that make up our leadership code are:

• Creating a culture that encourages innovation

• Establishing a meaningful purpose for the work we do

• Building a high-trust environment

• Treating people like people, not objects

• Building an active feedback loop

Innovation, purpose, trust, people and feedback — these five principles set a clear expectation of what our team members can expect from their leaders.

We have also invested significantly in deep training, libraries and new tools to help our people develop these skills at scale. Our efforts now are focused on creating professional coursework — developed in-house — and teaching the courses throughout the year.

Ultimately, we hope that we can build well-rounded leaders where the skills they learn can translate to other companies, other opportunities and other places. (continued on page 69)

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Each company will have its own leadership style and should develop a curriculum that is relevant to them.

Recently, we decided to offer a course covering the five aspects of our leadership code to interested customers at our October Masters Summit. Building for the future will benefit when companies work together — especially in an industry as critical to well-being as medical technology.

Enshrine the leadership process across the company

The organizational cost of poor leadership is astounding. Managing a department where employees and managers have strained relations requires a tremendous amount of time and effort from the C-level.

In an industry that thrives on innovation to improve health and save lives, it is important that we do not punish people for trying to innovate and not quite succeeding. A growth mindset encourages honest effort and embraces the opportunity to learn when coming up short. Enthusiastic support in disappointment, with a focus on lessons learned, is one area where a skilled leader can make a significant difference for their team and the company.

Poor leadership issues become a top priority for me whenever they crop up at MasterControl. At times I spend up to 25% of the month just trying to help leaders strengthen their teams, build leadership skills and encourage collaboration.

Building our leadership process across the organization helps us minimize the impacts of these challenges. Leadership skills need to be learned and reinforced, and everyone is encouraged to learn and apply them in their areas. This means individual leaders can have a direct impact on their teams as well.

Executives must understand the value of their own leadership and make sure they impart the lessons they have learned to the next generation. It is long past time for our industry to create the sort of entrepreneurial environment that feeds the growth of companies in all industries.

Companies can be filled with leaders who encourage innovation and embrace growth. By establishing a reputation for training leaders and creating programs that support team members, companies can open the doors to influencing the future.

Why Affera’s cardiac ablation technology is worth $1B to Medtronic

Medtronic’s Affera cardiac ablation system diagnoses, maps and treats heart arrhythmias with a unique diagnostic/therapeutic catheter.

Affera started in 2014 with a simple goal that paid off when Medtronic bought the company for up to $1 billion in 2022.

Achieving that goal, however, took some unconventional and sometimes difficult design choices, Affera founder and CEO Doron Harlev said.

Newton, Massachusetts–based Affera’s system diagnoses, maps and treats heart arrhythmias with ablation. It’s a process that scars heart tissue to interrupt errant signals. Affera’s system uses both radiofrequency (RF) ablation and the non-thermal pulsed-field ablation tech that has been generating buzz in medtech.

Complex arrhythmias like atrial fibrillation and ventricular tachycardia can require an electrophysiologist to perform more extensive ablation. But Harlev and his team at Affera thought a larger ablation tip could make these procedures easier. At the same time, the

larger tip would offer better durability. As a result, there would be a reduced chance that ablated tissue would heal and allow the arrhythmia to return.

“The very origin of the company ... was as simple as, ‘Let’s make a bigger tip,’” Harlev said. “The challenge is [that] we can’t just make it bigger because we’re not going to puncture a much bigger hole in the patient’s groin and advance that. So that means expandable ... and that drove a lot of the innovation originally.”

In an interview with Medical Design & Outsourcing , Harlev and Rebecca Seidel, president of the Cardiac Ablation Solutions business in Medtronic’s Cardiovascular Portfolio, discussed how Affera’s devices work, the challenges to develop them and what’s next for the technology.

“We’ve been following Doron and his team for a very long time,” Seidel said. (continued on page 72)

Affera’s Sphere-9 mapping and ablation catheter Photo courtesy of Affera

TUBING TALKS

(continued from page 70)

“They’re prolific inventors. And that’s what we were really most excited about, the fact that they’ve done all of this work. Although it may seem like it happens overnight when these deals happen, that’s not how it goes.”

What does Affera’s cardiac arrhythmia tech do?

Affera’s platform includes its Prism-1 system for high-density mapping and navigation. The platform combines Prism-1 with the minimally invasive Sphere-9 cardiac diagnostic and ablation catheter. FDA has not yet approved the technology for commercial use. However, Affera’s system has treated patients through an ongoing clinical trial under an FDA Investigational Device Exemption.

Affera’s lattice-tip Sphere-9 catheter expands after insertion into the heart and can deliver both radiofrequency and pulsed-fi eld energy. The Sphere-9 catheter isn’t just a therapeutic catheter; it does double duty by collecting data for arrhythmia mapping.

“It’s unique in that it allows us to perform what’s called high-density mapping with one device, and it was designed at the same time as the rest of the system,” Harlev said. “The rest of the system includes the therapy delivery subsystems for radiofrequency and pulsed-field ablation, as well as the mapping. These were all designed at exactly the same time and came to be at the same time, feeding off each other, which is relatively unusual.”

That simultaneous design approach helped streamline and simplify the entire system. As a result, electrophysiologists could more effectively diagnose and treat cardiac arrhythmia.

“EPs are considered — I don’t want to offend the other kinds of physicians — but they’re kind of the rocket scientists, the nerds, the techies, the geeks,” Harlev said. “It’s a very interesting field of medicine where there’s a lot of complexity. It necessitates a lot of manual dexterity to move into position a catheter, a lot of mental abilities to analyze and understand these squiggles that we call electrograms.”

“We’ve been following Doron and his team for a very long time. They’re prolific inventors. And that’s what we were really most excited about, the fact that they’ve done all of this work. Although it may seem like it happens overnight when these deals happen, that’s not how it goes.”

Affera’s cardiac ablation design challenges

The Sphere-9 catheter has a 9 mm compressible lattice nitinol tip with nine mini-electrodes (each with a temperature sensor) for energy delivery. Harlev said the choice of the spherical shape and the nickel-titanium alloy for the ablation tip was “provocative” but worked out.

“When you consider putting that into a heart and delivering energy through it, your first reaction might not be favorable,” he said. “When we decided to pursue that, we did it in a very staged manner. First, we did some simulations and thinking about the physics, then things on the bench to see if you’re seeing anything untoward, then there’s a variety of animal models you can use to gain confidence that this thing’s actually going to work, increasing the realism of how this device, for example, would interact with blood. Then eventually you go to patients, and even when you go to patients you can sometimes pursue indications that would be more forgiving and safe before you go to other indications.”

The most challenging times were when the Affera team wasn’t sure if they were headed in the right direction and whether their results were due to a major design fl aw or just needed a minor revision.

“When you’re charting new ground, going in a new direction, you don’t know when to continue to be stubborn and persistent and just get to a solution or to actually give up and say, ‘This is a dead end. Let’s take a different turn,’” Harlev said.

Affera initially considered more of a balloon-based design for the catheter tip, Harlev said, but abandoned that approach after more than a year of development to look into other solutions.

“Smelling burnt rubber after you’ve ablated is not pleasant,” Harlev said. ... “The way the Sphere-9 looks today — it’s funny, but it was actually Plan B. Sometimes when you’re doing a device that’s a little bit more derivative, sometimes you don’t even understand how many questions have been answered for you.” >>

Medtronic’s PulseSelect pulsed-field ablation catheter Image courtesy of Medtronic

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TUBING TALKS

Why did Medtronic buy Affera?

Affera’s technology complements Medtronic’s existing atrial and ventricular arrhythmia disease management portfolio. The acquisition also gives Medtronic its first cardiac mapping and navigation platform.

“We’ve been super successful with the cryoballoon therapy, but that’s a pulmonary vein isolation tool and as a patient’s disease progresses, physicians want to do other things besides pulmonary veins. They want to treat different parts of the heart,” Seidel said. “When you get into that space, that’s when you need a mapping and navigation system to be able to tell you where you are and where you’ve ablated. We need that. We have our DiamondTemp catheter, a focal catheter and our PFA catheter, and even with some cryo, when they go to second procedures, they want to see where they’ve been. So it’s critically important for us to be able to expand our portfolio with mapping and navigation.”

The Sphere-9 catheter’s large footprint and dual abilities also stood out from the field, Seidel said.

“The Sphere-9 tool is a mapping catheter and a therapeutic catheter, which is differentiated from anything in the market. We don’t see that anywhere,” she said. “And we feel like that’s an exciting opportunity for physicians, so they don’t have to exchange the catheter or have a second catheter to do the mapping and the ablation.”

What’s next for Medtronic and Affera Harlev and Seidel could not say when they hoped to win regulatory approval for Affera’s technology.

Affera’s multicenter trial of its Sphere-9 catheter for treating persistent atrial fibrillation is expected to be complete in November 2023. Medtronic expects results from a clinical trial of its own pulsed field ablation system, PulseSelect, in early 2023.

Is Medtronic big enough for two PFA offerings?

“The physicians are going to tell us what they like best,” Seidel said. “And the clinical trials will tell us if they are efficacious and how the patients do. I think

the PulseSelect are just as different as those two are.”

Harlev and Seidel hope to advance the field of pulsed-field ablation by bringing engineers from Medtronic and Affera

The Affera system cart for radiofrequency and pulsed-field ablation

Photo courtesy of Affera

that’s where we’re all going to learn. ... It’s so early, and I think there’s room for both.”

Harlev also weighed in. “Different patients need different tools and different physicians have different preferences. So that’s why we can have simultaneously something like the cryo Arctic Front be very successful while the J&J ThermoCool is very successful. ... The Sphere-9 and

together to share what they’ve learned. The Affera team spent significant time dialing in the energy delivery. Also, they brought patients back for “remapping” a few months after ablation. Their goal was to evaluate how well the procedure worked.

“We certainly had our share of disappointments early on,” Harlev said. ... (continued on page 77)

“When you’re charting new ground, going in a new direction, you don’t know when to continue to be stubborn and persistent and just get to a solution or to actually give up and say, ‘This is a dead end. Let’s take a different turn.’”

(continued from page 74)

“Unfortunately when it comes to PFA, in part because it’s so new and in part probably because of physiological reasons, what you learn from animals is not sufficient. You have to move forward in your development. One aspect is optimizing the dose. ... Because this device is part of a mapping system, it can monitor a lot of parameters right before and during delivery and give feedback on how well you’ve likely done or maybe where you should be touching up.”

Can Medtronic help take Affera technology to the next level?

Bringing the two companies together makes it more likely that Affera’s technology will take off.

“They’ve been working on this technology for quite some time.” Seidel said, “and we have super high confidence that they’ve done all this iterative work and are making this technology super successful. ... What we bring is a large

team that can help scale the technology as well as a sales and commercial channel to bring it to market.”

Harlev compared the work ahead to Medtronic’s efforts to generate clinical data and prove the benefits of cryoablation. Medtronic bought Arctic Front cryoballoon catheter developer CryoCath in 2008.

“We all know how successful and helpful cryo has been — and it was an acquisition — but it took a tremendous amount of work,” Harlev said.

“Medtronic is quite unique in its ability to bring big innovations and turn them mainstream.”

Affera founder and CEO Doron Harlev

Medtronic Cardiac Ablation Solutions President Rebecca Seidel

JIM HAMMERAND MANAGING EDITOR

The home dialysis developer's CEO discusses leadership, leaping before you look and making medtech for the home and hospital.

Eight years after becoming the CEO of Outset Medical and two years after going public, Leslie Trigg says the medtech developer is finally at the starting gate for home dialysis. It hasn't been easy. The COVID-19 pandemic made it unsafe to train nurses in person, even as hospitals used the Tablo hemodialysis console in hallways and waiting rooms to clean patients' blood. The pandemic also disrupted Outset's supply chain. For example, it increased transportation costs for its single-use cartridges made by a contract manufacturer in Southeast Asia.

Last year, Outset had to put new shipments on hold while working through a submission review with the FDA.

And when she first got involved with the company, Trigg — who's not an engineer or a doctor — didn't know much about dialysis. But that worked in her favor, she said at our DeviceTalks West show. The October 2022 event in Santa Clara was near Outset's San Jose, California headquarters.

"Trust your instincts," she told the hundreds of medtech insiders in attendance for her interview with DeviceTalks Editorial Director Tom Salemi. (continued on page 80)

Leslie Trigg is CEO and chair of Outset Medical. Photo courtesy of Outset Medical

“Dialysis is definitely a pretty insular space. There is a lot of innovation happening, but it’s still largely controlled by only a couple of players. You need people who are going to come in and deliver some significant improvements in not only the patient outcomes and the economics, but also the experience.”

(continued from page 78) "Often, it is the greatest advantage to sort of have that beginner's mindset because you will ask those sort of why and why not questions and be open to the answers that you find on your own."

It'll take a different mindset to disrupt the dialysis space, currently controlled by DaVita and Fresenius Medical Care. Outset's results under Trigg's leadership show what she's contributed to the company and the future of dialysis treatment, MedTech Innovator CEO Paul Grand said.

"Dialysis is definitely a pretty insular space. There is a lot of innovation happening, but it's still largely controlled by only a couple of players," Grand said. "You need people who are going to come in and deliver some significant improvements in not only the patient outcomes and the economics, but also the experience. You've got to have a reason for people to either switch or for people to want to adopt a totally new modality in terms of dialysis at home."

"It just requires a different kind of thinking," he continued. "And it sounds like Leslie has done a good job of bringing that to the company."

With Outset at an apparent inflection point, Trigg discussed leadership lessons she's learned. She also spoke of the promise of the company's dialysis technology — and making medtech that works as well at home as it does in the ICU.

Starting at Outset with a beginner's mindset

When Trigg started working with Outset in 2013, the company only had four employees. Following leadership roles at FoxHollow, AccessClosure and Lutonix, she was an executive in residence at Warburg Pincus, the private equity firm that held Outset in its portfolio.

Eighteen months later, Trigg would officially become CEO. One Friday night, she was in her backyard and got a call from Warburg asking if she was interested in taking charge — and giving her until Monday to decide.

"I had 48 hours to think about it. ... But I absolutely leapt before I looked," she said.

Up to that point she hadn't thought about becoming the CEO, hadn't done a structured market analysis, or given it deep consideration, she said.

"I guess I was just moved probably more on a primal level emotionally," she said. "And I knew we could vastly up-level the [dialysis] experience. And I knew we had the capacity as a group of technology people to do that."

For years after that, her top criteria when hiring people was whether they also were willing to leap before they look — partially out of necessity because the company's failure was a strong possibility, if not a probability, Trigg said.

(continued on page 82)

Leslie Trigg and DeviceTalks’ Tom Salemi

Photo by Kara Singleton for Medical Design & Outsourcing

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(continued from page 80) "When I'm interviewing somebody, I'm always looking for a blend of a thinker, a doer and a believer," she said.

Even as CEO, Trigg said she wasn't the right fit for the job at that early stage, given that her expertise was more in commercialization than development or engineering. But that beginner's mindset was valuable.

"I was brought into that company way too early, and I didn't have a lot to add to many meetings other than curiosity and common sense. Now I happen to think that those two things count for a lot," she said. "I hope that I added some value because I definitely knew what the end part was going to look like, to hopefully help guide some of the decisions around scope in the early stages of Tablo, because I did have a very clear view of what was going to sell."

Today, Outset Medical is a publicly traded company. It sells its FDA-cleared Tablo Hemodialysis System, used by tens of thousands of dialysis patients. In 2022, Trigg became chair of Outset's board as well as chair of the Medical Device Manufacturers Association.

Outset Medical has yet to post a profit as it invests in R&D and sales efforts, but its recent revenue gains make it one of the fastest-growing companies in medtech and in the world, ranking 33rd on Deloitte's 2022 Technology Fast 500 in November.

Outset Medical founder and former CEO Michael Baker remains an investor in the company, though he's currently focused on his medical informatics companies, Cori2 and QView Health.

"I’m very pleased with the performance of the company and that the vision for the technology and user interface have been maintained and improved since we first invented the system," he told Medical Design & Outsourcing.

Outset Medical's Tablo system

Outset Medical's Tablo console is a compact hemodialysis machine used at home, in clinics, nursing homes, hospitals and even intensive care units. Formerly known as Home Dialysis Plus, the company won its first FDA 510(k) clearance for Tablo in 2014.

At the time, NxStage Medical was the only company with a home

hemodialysis device, which won FDA clearance in 2005.

But the Outset Medical team thought they had an opportunity, deeming the NxStage System One as too complicated to operate. NxStage Medical’s device had also failed to move many dialysis treatments out of clinics and into the home.

The more Trigg learned about the dialysis business, the more opportunity she saw to make a profound difference in an industry "frozen in time."

"What I saw really did shock me," she said. "I saw a very stale care delivery model where everybody was just sort of herded into the assembly line environment of dialysis clinics three times a week. It's going to be: Show up, sit down and shut up. I saw devices and technology from the 1980s ... like I was digging out a time capsule."

She spent time in clinics and spoke with patients, learning how they might spend hours of travel time because they had little or no choice in which dialysis clinic they would visit for treatment, let alone which chair they would sit in or which tech would stick them with needles.

"It is absolutely the classic definition of learned helplessness. They've done it brilliantly. Being in that clinic communicates to you in every way that you are not capable, you're not smart enough, don't touch that. Alarms are constantly going off," she said.

And then there's the smell. Dialysis clinics have water treatment rooms for purifying water and making the dialysate to pull toxins out of the blood.

"I had a physician tell me, 'You can smell a dialysis clinic before you can see it.' ... It smells like chemicals. And to be honest, it kind of smells like death. (continued on page 84)

“I guess I was just moved probably more on a primal level emotionally. And I knew we could vastly up-level the [dialysis] experience. And I knew we had the capacity as a group of technology people to do that.”

Outset Medical’s Tablo Hemodialysis System is designed for use in healthcare facilities and homes.

Photo courtesy of Outset Medical

TOP: Outset Medical’s Tablo device has a touchscreen that can display software for home users or health care professionals.

BOTTOM: A patient who uses Tablo’s Hemodialysis System at home.

Photos courtesy of Outset Medical

(continued from page 82)

You are surrounded by people who effectively are dying — ESRD stands for end-stage renal disease," Trigg said.

Home dialysis, on the other hand, lets patients stay in control and keep their confidence and sense of self-worth, dignity and identity, she said.

Home dialysis machines need to be easy for a patient to operate and small enough to fit inside a home. The Tablo console is about three feet tall to make it more approachable and less intimidating than the dialysis clinic machines that loom over patients.

Instead of water treatment rooms and plumbing systems, the Tablo console hooks up to a kitchen or bathroom sink with a hose to draw tap water. The device then filters, purifies and automatically turns the tap water into dialysate according to a nephrologist's prescription. A touchscreen display, automation system and a singleuse cartridge for the arterial and venous bloodlines make setup quick and easy.

Engineers designed the system so a person could operate it even if they had only one hand, said Manish Khemani, Outset's senior manager of systems and test engineering.

"We have actually 70 sensors in our system, which is unheard of in a medical

device," he said. "We wanted to monitor every single performance that we could, and we could improve the performance of the system over time. We could learn what the system is doing and eventually use machine learning and AI to help improve in real-time."

One controversial design decision was adding a door, an idea that nurses hated, according to Outset's market research. The nurses wanted to see inside the machine to spot blood clots or leaks. Why not solve those problems, Trigg thought, and spare patients from watching their blood circulate through the device?

"There's a lot of good thinking and clarity around who is your consumer, and now we have confl ict. And it's really interesting because as the vision evolved from home, it expanded to hospital," she said.

Over successive iterations and FDA clearances, the team added features for hospitals and ICUs. There were also new capabilities such as wireless communication for cloud connectivity. Connecting with the cloud enables nurses and Outset techs to check on machines remotely. Plus, the machines can remotely report performance metrics.

"Data is priceless," said Binny Chatrath, Outset software test director. "It helps us learn and understand to train and most importantly, improve users' experience. ... During COVID, we really had to figure out how to get the training to the virtual cloud so anybody can do training in their home."

The TabloCart accessory for hospital use adds more maneuverable wheels. There are also optional features such as a storage drawer and water prefiltration.

"We couldn't suddenly make this so that only nurses could use it," said Amy Kerdok, Outset's former director of product management. "We still needed patients to be able to use it. So we solved that problem by splitting the software into two personalities. We had a professional care kind of mode that could do all these advanced treatments, open up alarms, open up the ability for nurses to troubleshoot, but we still kept the patient side or the self-care side so that a patient could utilize it at home."

Tablo's patient-focused design showed promise. Patients using the device at home in clinical studies stayed (continued on page 86)

(continued from page 84) on them throughout the trial versus a 25% dropout rate for the incumbent device. And patients reported fewer symptoms and more energy after their treatments rather than feeling drained.

"Patient after patient after patient talked about actually physically feeling better," Trigg said.

The FDA cleared Tablo for home use in March 2020. The device was used by a patient at home for the first time postclearance in July of that year. Outset went public through an IPO that September, with its stock popping 125% by the close of its first day on the Nasdaq exchange.

In 2021, Outset opened a console manufacturing facility in Tijuana, Mexico, through a partnership with outsourced business administration service provider TACNA. Later that year, Outset entered into another Mexican outsourcing agreement, qualifying a second manufacturer for its Tablo cartridges.

Machines

on hold

In June 2022, the company froze shipments of its at-home devices while the FDA reviewed a new 510(k) submission with changes made since the first March 2020 at-home clearance. The company's stock had already been slipping, but the news sent the share price to new lows.

The FDA wanted Outset to re-run its human factors study for the latest changes and later asked for a third run of the study.

"We reran this human factors study twice," Trigg said. "Never because of the data, by the way — lesson for everybody [in medtech] — it was the protocol, and the depth and the breadth of the protocol. Our data was pristine."

The study originally submitted by Outset tested about 1,000 tasks, Trigg said, but the third study that the FDA accepted tested more than 7,000 tasks.

The FDA's reviews likely took longer than they would have before the pandemic due to turnover at the agency. Outset's 2020 submission for at-home clearance had five FDA reviewers over 10 months, while the 2021 review had at least three reviewers, Trigg said.

Outset held shipments for eight weeks, waiting for FDA to clear the latest submission.

"We are back," Trigg said. "We have been back since Aug. 1."

Home dialysis tailwinds

In November, the company increased its revenue guidance for 2022 to a range of $111 million to $113 million, which would be 8-10% growth over 2021. As of mid-December, the company's stock was trading at pre-shipping-hold prices, but still less than half of the IPO day's close.

"We're finally at the starting gate on home," Trigg said. "... Within the dialysis space and within renal, all of the stars are finally aligning."

The COVID-19 pandemic has accelerated the development of telehealth technology and got patients to accept and in many cases prefer treatment at home. Meanwhile, the Centers for Medicare & Medicaid Services has implemented new financial incentives for dialysis clinical and nephrologists to support at-home treatment.

"What I'm the most excited about is finally actually delivering on the original mission and the vision," Trigg said. "I want to see 100,000 patients at home. All-in and including peritoneal dialysis, which is a different modality of home, we're probably at 70,000 patients [in the] home. How do we get 100,000 on Tablo? I think that's largely going to occupy our imagination for quite some time."

It's a new beginning for Outset and Trigg — and that's exactly the mindset she wants.

“What I’m the most excited about is finally actually delivering on the original mission and the vision. I want to see 100,000 patients at home.”

The single-use Tablo cartridge Photo courtesy of Outset Medical

SEAN WHOOLEY ASSOCIATE EDITOR

Bill George's leadership experience speaks for itself.

He served as chair and CEO of Medtronic across the 1990s and into the mid-2000s. That came after stints as an executive with Honeywell and Litton Industries. Since 2004, he has taught leadership at Harvard Business School, where he now holds the role of executive fellow. (continued on page 90)

The medtech veteran o ers his advice for leaders in the industry — and how to make opportunities for aspiring leaders to rise.

Former Medtronic CEO and Chair Bill George

Photo courtesy of Bill George

(continued from page 88)

George recently published a new version of his book, "True North: Emerging Leader Edition." In it, he discusses the need for a transition to a new crop of leaders. He spoke with Medical Design & Outsourcing about his book, leadership in the medtech space and leadership altogether.

"For the last 20 years, I've been working on trying to develop more authentic leaders at Harvard and other places, working with a lot of corporations. I wrote the new book because I think it's time for a new generation," George said. "The baby boomers have had their day."

Some answers in this Q&A have been edited for clarity and length.

What needs to change in today's leadership

George credits the previous generations with producing great leadership, mentioning Microsoft CEO Satya Nadella, former Medtronic CEO Omar Ishrak and General Motors CEO Mary Barra. But he said it's time for a change.

"What's really changed is that the old command-and-control-style, top-down leadership practice — Jack Welch-style, if you will — will not work today. I think we need a whole new form of empowering leadership. I think leaders should look at themselves less as directors and managers of people and more as coaches of people. It is time for the new generation to really understand the millennial generation and what their needs are, their desires.

"Frankly, people today are not primarily concerned with maximizing shareholder value. They're concerned with leading with a sense of purpose. And if your company doesn't have that purpose, they don't want to work there. At Medtronic, fortunately, we had a mission that Earl Bakken, our founder, put in long before I arrived. There was a dominant driving force in the company for restoring people that full life and health."

Fostering innovation and leadership through COACH-ing George discussed an acronym created to describe fostering leadership: COACH.

The C stands for care — in letting people know you, as a leader, care about them. O stands for organize — using peoples' strengths and finding places they're most effective in the organization.

A stands for align — allowing people to find the alignment between their personal purpose and that of the company. The second C stands for challenge — because "any good coach is going to challenge you back," George said. Finally, the H stands for help.

"I think leaders today need to get in and work with people to help them, not just stand back and judge," George said. "That was the old style — stand back and judge, giving a performance review once a year and telling them how they're doing. Let's engage with people. We have a problem? Let's get everyone together around the table and solve the problem. Bring in the best people we can. That's what we tried to do at Medtronic. This is the motto we tried to follow."

George added that leaders have to look at their roles differently today. There's a difference between managers and leaders.

"There are millions of managers out there. There are not enough leaders," George explained. "Leadership is revealed in a crisis. ... You have any kind of crisis like COVID, you find out who the real leaders are, who's going to step up in that time. The people who take charge aren’t necessarily the ones with the big titles, and to me, those are the real leaders."

How to create and maintain culture within an organization

George said the alignment aspect of COACH represents a major building block in creating culture, especially in medtech.

Finding people with the same values as the company — people who put human life first and know that restoring health is the mission — is paramount. "I believe that you get people who keep the vision out there, where you're going to restore people to full life and health," George said. "You put the focus on your company's mission and its values. I used to tell people at Medtronic, 'We're here to alleviate pain, restore health and extend life. If that doesn't turn you on, probably should go to work for Merrill Lynch and trade stocks. You're in the wrong field. (continued on page 92)

“I think leaders today need to get in and work with people to help them, not just stand back and judge. That was the old style — stand back and judge, giving a performance review once a year and telling them how they’re doing. Let’s engage with people.”

(continued from page 90)

But if it excites you, you'll have a fantastic career, and at the end of the day, you realize all the people you've helped.'"

As for turning that into innovation, George referenced Disney's recent CEO change and said you can't centralize creativity. Leaders don't have to be innovators, but they have to create an environment where the innovators can flourish.

"I didn't invent anything. But I did support the innovators at Medtronic. ... The leaders in this industry have to be willing to take risks and recognize that things will fail. And some things will take a very long time," George explained. "You have to have a tolerance for risk, and you have to have the long-term view. If you don't have that, if you just want to make the quarterly numbers, you probably won't make it in this industry for the long term. You might make the numbers this quarter, but in the end, you'll get the culture that doesn't innovate, and you won't have it."

Who in medtech stands out right now from a leadership perspective

Of the current leaders in medtech, George agreed to name a few that he thinks are doing a particularly strong job. Stryker CEO Kevin Lobo made what has always been a great company greater, he said. Mike Mahoney "turned around Boston Scientific."

Soon-to-retire Mike Mussallem has done an "amazing" job at Edwards Lifesciences. George also credited former Medtronic CEO Omar Ishrak and his successor, Geoff Martha, saying, "There's no doubt they're on the right track."

Altogether, the medtech industry needs these types of leaders, he said, because the need for medical technology isn't going away.

"It's an industry that has been overlooked because of the dominance and size of the pharmaceutical industry," George said. "I think what medical technology has done is transformed so many lives over the last couple of decades. Through great innovation, great technology and blending electrical

technology and mechanical technology and digital technology and now software, it's fantastic, the lives that have been saved and restored by medical technology. It's a fantastic industry with enormous upside potential."

How to recruit and retain talent

When asked about recruiting top talent as times and people change, George had a quick counterpoint.

"The first thing you do is you develop the people you have. I think

purpose and an opportunity they wouldn't get elsewhere. Companies that do that are going to flourish. Companies that don't are going to struggle."

Advice for future leaders

For anyone who aims to lead a company big or small, whether tomorrow or in 10 years, George said experience counts. "Get a chance to go run something," he said. "If you're not the inventor yourself, work with a group of engineers, create a new product create a whole new business. Make a venture out of it and build it into a mainstream business. ... That's the greatest growth experience you can have."

It's a path George himself followed, and he explained that the freedom to make mistakes still leads to the experience needed to effectively lead.

"If [top leaders are] looking for perfection, they're in the wrong industry," George said. "Give people the opportunity to show what they can do. … They'll exceed your expectations. Not everyone, but an awful lot of people will."

Advice for anyone in medtech

companies have neglected that," he said. "I think there needs to be a lot more emphasis on leadership development. Figure out who the real leaders are and give them an opportunity. ... You want to develop the talent you have. Give them the leadership roles, and you'll be shocked at how well they perform."

He emphasized that the door must be open to pave the way for young leaders to come along. Otherwise, they'll leave. The issue, George said, is not just talent recruitment, it's the loss of talent.

"As far as talent recruitment, if you've got great leaders in your company, they're going to recruit people that are like them and are going to recruit very talented people," he said. "That's what I would look for. I would start early and try to get high levels of retention because your company's paying them well, but beyond that, you're giving them a real sense of

While at Medtronic, George said he had a policy to never lay off engineers or salespeople. "They were the cogs that made our organization go," he said.

Give people the freedom to try things by investing heavily in R&D, and you'll figure out what the industry wants.

"In this industry, the engineers [should] get close to the doctors. Get to know the real innovative doctors, the physicians on the cutting edge. Because they'll have ideas you never thought of. ... Get out and develop these partnerships, get out and talk to the doctors. ... That's where life and death hangs in the balance. Then you can understand the importance of quality, innovation and breakthrough ideas and how important it is that they work for the doctors, not just in the engineering lab."

“The first thing you do is you develop the people you have. I think companies have neglected that. I think there needs to be a lot more emphasis on leadership development. Figure out who the real leaders are and give them an opportunity”

Medtech’s biggest of 2022

Philips tapped Roy Jakobs (pictured) to replace longtime CEO Frans van Houten in fall 2022 as the company worked through a massive respiratory device recall.

Hired, fired and retired — Medtech leaders at some of the industry's largest companies made news with big moves, including surprising exits and wellearned promotions.

SEAN WHOOLEY ASSOCIATE EDITOR

Medtech leaders made big moves in 2022 with hirings, firings, promotions and retirements of CEOs, presidents and other business leaders across the industry.

To close out last year and move forward with 2023, here are the biggest medtech moves of the past 12 months — and some updates since the news broke.

Smith+Nephew names new CEO as Diggelmann steps down In February, Smith+Nephew said it would replace CEO Roland Diggelmann

with Deepak Nath. Nath took over the orthopedic device company's corner office on April 1.

Nath was previously president of diagnostics at Siemens Healthineers. Before that, he held senior roles at Abbott over the course of about a decade, eventually becoming president of Abbott’s vascular business.

Medtronic makes a multitude of moves Medtronic in March announced three new business heads covering its diabetes, surgical robotics and cardiac rhythm units. (continued on page 96)

Photo courtesy of Philips

Medtronic EVP and Diabetes President Que Dallara

(continued from page 94)

Que Dallara became EVP and president of the diabetes business, Mike Marinaro became president of surgical robotics and Dr. Kweli Thompson became president of cardiac rhythm management.

Dallara took over for Sean Salmon, who will focus exclusively on leading the cardiovascular portfolio, while Marinaro succeeded Megan Rosengarten, who took a sabbatical leave.

In April, Medtronic promoted Dr. Laura Mauri to chief scientific, medical and regulatory officer. The company then hired Dr. Ashwini Sharan as chief medical officer of its neuromodulation operation unit in June.

Presidents rotate through BD’s medical segment

In March, BD announced the retirement of Alberto Mas, EVP and president of the company’s medical segment, after more than 30 years with the company.

BD replaced Mas with Simon Campion, but he left BD a few months later to become CEO and president at Dentsply Sirona. BD then tapped Mike Garrison to lead the segment. Garrison was previously worldwide president of BD Medication Management Solutions and before that worldwide president of BD Surgery.

Dentsply executes a slew of leadership changes

After firing CEO Don Casey in April, Dentsply Sirona launched an internal investigation. Soon after, former CFO Jorge Gomez left his new job as CFO of Moderna.

The changes didn’t stop there.

In August, Dentsply appointed former BD executive Simon Campion as its new CEO. About one week later, Dentsply announced SVP and Chief Commercial Officer Walter Petersohn's departure from the company. Dentsply originally said Petersohn’s exit was a mutual decision, but in November, revised the departure to a termination “following subsequent discussions” with him, according to an SEC filing.

In late September, Dentsply found Gomez’s permanent replacement in new CFO Glenn Coleman, formerly of Integra LifeSciences.

Dentsply eventually provided more clarity on the situation with Casey and Gomez. In November, the board’s audit committee announced that it found no

evidence of intentional wrongdoing or fraud on the part of its former CEO or CFO.

The company disclosed $45 million in costs through September associated with the internal investigation, including lawyers, forensic accountants, remediation expenses, severance costs and one-time payments to keep key personnel.

Petrovic steps down as Insulet CEO

In a surprising move, Shacey Petrovic announced in May her resignation as president and CEO of Insulet due to personal reasons.

Petrovic joined the automated insulin delivery device maker in 2015 and led it since January 2019. She continues to serve on the board and will advise the company through May 2023 to support the leadership transition to new CEO Jim Hollingshead.

Hollingshead left sleep respiratory technology developer ResMed for the new job. ResMed tapped Lucile Blaise to replace him as president of its sleep and respiratory care business.

In December, Insulet announced COO and EVP Charles Alpuche's intent to retire at the end of 2022. Insulet said it would promote Prem Singh, VP and head of global supply chain operations, to SVP, global operations, at the start of 2023.

Fresenius CEO leaves after short stint Fresenius Medical Care announced in May that CEO Rice Powell would step down after reaching the company’s age limit. The company selected Carla Kriwet, 51, to succeed Powell as of Jan. 1, 2023.

However, Kriwet took over on Oct. 1, the company said in SEC filings. Deputy CEO and CFO Helen Giza assumed “certain functions of the role of chief executive officer for a brief interim period,” the filings said.

In early December, Fresenius said Kriwet was out, and Giza was in as the medical division’s next CEO. Fresenius said Kriwet’s departure was “at her own request and by mutual agreement due to strategic differences.”

Ambu

switches CEOs

Single-use endoscopy technology developer Ambu announced in May that it would replace CEO Juan Jose Gonzalez with board member Britt Meelby Jensen. (continued on page 98)

Medtronic Chief Scientific, Medical and Regulatory Officer Dr. Laura Mauri

Retired BD EVP and Medical Segment President Alberto Mas

Former Insulet CEO Shacey Petrovic

Former Fresenius Medical Care CEO Carla Kriwet

(continued from page 96)

“The COVID-19 pandemic, the recent macroeconomic headwind and a weaker than originally expected financial performance require that we execute differently on our strategy,” Ambu Chair Jørgen Jensen said at the time.

Meelby Jensen was CEO of Atos Medical from 2019 until March 1, 2022, stepping down after the laryngectomy care company’s acquisition by Coloplast. Before that, she was CEO of Zealand Pharma from 2015 to 2019, leading the metabolic disease therapeutic maker through its 2017 IPO.

Titan Medical names new CEO

On June 30, Titan Medical announced that it appointed Cary Vance as president and CEO.

Paul Cataford had been standing in as interim president and CEO for about six months after David McNally stepped down in December 2021. No reason was provided for his departure.

Vance was previously president and CEO at privately held neurovascular robotics company Xcath, and held similar roles at Optiscan Biomedical and Myoscience. He was also president and CEO at Hansen Medical, a publicly held intravascular robotics company acquired by Auris Health in 2016 before Auris was acquired by Johnson & Johnson in 2019.

3M’s healthcare president retires Mojdeh Poul, the president of 3M’s healthcare business, announced she would retire effective July 1. 3M named Jeff Lavers as her interim replacement, and in July announced plans to spin off the healthcare business by the end of 2023.

Poul joined 3M in 2011 as the global business VP of critical and chronic care solutions. She later became VP and general manager of the company’s food safety business and president of numerous 3M divisions, including infection prevention, 3M Canada, and safety and graphics.

David Pierce, who served in a multitude of roles of increasing responsibility at Boston Scientific since 1991, retired

Boston Scientific selected Arthur Butcher, EVP and President of the Asia

Pacific region, to serve as EVP and group president of both medsurg and Asia Pacific while remaining an executive officer of the company.

The company also promoted VP and GM of endoscopy Michael Jones to SVP and president of endoscopy.

Philips replaces CEO amid respiratory recall

Philips announced in August that longtime CEO Frans van Houten would leave the company, replaced by Roy Jakobs. Shareholders approved the move in a Sept. 30 special meeting, making the change official as of Oct. 15.

Van Houten was the face of Philips as it struggled with its still-ongoing Respironics recall. After becoming CEO, Jakobs offered an apology and promised improvement. The company soon after announced 4,000 job cuts, equal to about 5% of its global workforce.

A late summer update on the recall listed 69,000 medical device report (MDR) entries since April 2021, including 168 reports of death. In November, that number increased to more than 90,000 reports of problems, including 260 mentioning deaths.

Dexcom promotes COO from within In August, Dexcom promoted Chief Technology Officer Jake Leach to chief operating officer. Quentin Blackford, who left in 2021 to become iRhythm’s CEO, previously held that position.

Leach served as CTO since 2018, leading the company’s research, product development, product management and engineering departments. He joined the company in 2004 to lead the development of sensor electronics for its first commercial continuous glucose monitor (CGM) system.

Since Leach’s promotion, Dexcom has taken big steps forward, including the recent FDA clearance of its nextgeneration G7 CGM.

Invacare fires CEO

In August, Invacare announced the removal of President and CEO Matthew Monaghan from the corner office.

Elyria, Ohio-based Invacare also ended Monaghan’s role as chair of the board. However, the company said Monaghan would stay on the board as a director. (continued on page 100)

Britt Meelby

Philips CEO Frans van Houten

Dexcom COO Jake Leach

Fresenius Medical

Edwards Lifesciences CEO and Chair Michael Mussallem

(continued from page 98)

The company attributed the changes to its efforts to advance its business transformation initiatives. It also sought to address supply chain challenges and strengthen its financial performance.

Invacare named SVP and GM of EMEA and APAC Geoffrey Purtill as interim president and CEO. It initiated a search for a permanent replacement for Monaghan.

Cardinal Health promotes CFO to corner office

Cardinal Health named CFO Jason Hollar as its new CEO effective Sept. 1.

Hollar succeeded Mike Kaufmann, who was CEO of the Dublin, Ohio–based company for the previous five years. The change came as Cardinal Health continues efforts to refocus its Medical business after selling its Cordis business last year for $1 billion.

Chief Accounting Officer Patricia English stepped in as interim CFO. In December, Cardinal Health said it hired Sysco EVP and CFO Aaron Alt for the job effective Feb. 10, 2023.

Verily selects new CEO

When announcing a $1 billion investment from parent company Alphabet in September, Google’s Verily also announced leadership changes for the company’s next phase of growth.

Verily named founder Andy Conrad as executive chairman of the board and promoted President Stephen Gillett to CEO. Both changes take effect in January 2023.

Owens & Minor names new healthcare CEO

Owens & Minor in October appointed Andrew Long as EVP and CEO for its products and healthcare services segment.

Long replaced Jeffrey Jochims as leader of the business segment. Owens & Minor did not explain the departure.

Owens & Minor promoted Alexander Bruni to assume Long’s former roles of EVP and CFO. Long served in those roles since joining the company in November 2019.

Roche Diagnostics picks regional leader as new CEO

In October, Roche promoted Matt Sause to CEO of Roche Diagnostics. Sause, 45, previously oversaw the company’s North America region.

His promotion and addition to the company’s executive committee is effective Jan. 1, 2023.

Stepping up to fill Sause’s vacancy is Brad Moore, serving as president and CEO of Roche Diagnostics North America effective Jan. 1. Moore most recently served as SVP of core lab and point of care within Roche Diagnostics North America.

Sause replaces former Roche Diagnostics CEO Thomas Schinecker, who is becoming CEO of Basel, Switzerlandbased parent company Roche effective March 15, 2023.

The Roche Board of Directors has proposed outgoing Roche CEO Severin Schwan as its new chair on March 14, 2023.

Butterfly Network CEO steps down Butterfly Network said in December that it reached a mutual agreement with Dr. Todd Fuchterman to step down as president and CEO. Fruchterman also left Butterfly’s board of directors.

Fruchterman oversaw Butterfly’s development of artificial intelligencebased handheld ultrasound technology. But the company’s had a rough go in recent quarters, with missed financial expectations and layoffs to conserve cash.

Butterfly said Fruchterman would work with the leadership team through the rest of the year to ensure a smooth transition. The company chose founder and Chair Jonathan Rothberg to serve as interim CEO as it searches for a permanent replacement.

Activ Surgical promotes new CEO

In December, Activ Surgical promoted COO Manisha Shah-Bugaj to the role of CEO, replacing Todd Usen.

Shah-Bugaj served as COO at Activ Surgical since January 2022, leading

the company’s impending global commercialization efforts around the ActivSight intelligent light.

Usen will remain on the advanced surgical visualization tech company's board of directors.

J&J CEO to become chair of the board

In December, the Johnson & Johnson board of directors elected CEO Joaquin Duato to take the position of board chair.

Duato succeeds Alex Gorsky, who intends to step down from the role following a brief transitional period. Duato's appointment takes effect in January 2023.

In August 2021, Gorsky announced plans to hand the CEO role over to Duato, citing family health reasons. Gorsky remained on as executive chair following a spate of leadership moves at the start of 2022. As part of the changes, Duato assumed the CEO role and joined the board on Jan. 3, 2022.

Edwards Lifesciences CEO to step down Edwards Lifesciences Chair and CEO Michael Mussallem is set to leave the corner office in 2023.

Mussallem, 70, informed the board of his decision to step down as CEO in May when Edwards holds its annual meeting of stockholders. Edwards said Mussallem intends to stand for election as non-executive chair of the board at the May 11 annual meeting.

Bernard Zovighian is slated to succeed him as CEO. Zovighian currently serves as corporate VP and GM of Edwards’ transcatheter mitral and tricuspid therapies (TMTT) business.

Zovighian takes over as president effective Jan. 1 until he becomes CEO in May. Edwards said he and Mussallem will work closely with the board and executive leadership team to ensure a smooth transition.

Edwards also named Larry Wood to the expanded role of corporate VP and group president, TAVR and surgical structural heart. He previously served as VP and GM of the TAVR business. Daveen Chopra, who served as VP and GM of surgical structural heart since 2018. will lead the TMTT business.

— Managing Editor Jim Hammerand contributed to this report.

Interpower® North American 5-15, 5-20, 6-15, and 6-20 hospital-grade cords never leave our facility without thorough examinations—they are rigorously tested to surpass UL 817 (18.2.4.1) and C22.2 No. 21-14 requirements for hospital-grade power cords and cord sets—and VDE requirements. They provide the correct “doses” of amperages and voltages for vital diagnostic medical equipment such as portable CT Scanners and X-ray machines, medical-grade treadmills, ECMO machines, and ventilators. Interpower North American hospital-grade cords come with NEMA hospital-grade plugs bearing the “green dot.”

Interpower hospital-grade cords and components ship the same day if in stock. All cords provide the customer with the correct North American connections to the local mains power, which means our cords are ready to use right out of the box. Order 1 cord or 5,000 cords. Made in America’s heartland in Oskaloosa and Lamoni, Iowa.

DEVICETALKS

5 tips from medtech leaders for the next generation

DeviceTalks guests offer advice for building successful careers in the medtech industry.

When interviewing senior executives on our DeviceTalks podcasts, I always start by asking how they got into medtech.

Tom Salemi | DeviceTalks Editorial Director |

Starting at career square one allows us to walk through the decisions that led to their success. I like to spend a few minutes examining those critical crossroad moments when the guests chose to leap into a new opportunity.

These interviews are full of lessons and tips for younger medtech professionals to equip themselves with experience and insights that will help develop them into leaders of the future.

You’ll need to listen to our past episodes for every bit of great advice. But we pulled these particularly helpful tidbits to help you build your successful career.

Tip 1: Run to the fire

Michael Mahoney surprised many when he left a senior role at Johnson & Johnson to take the CEO role at Boston Scientific. Boston Scientific was struggling, with a market capitalization almost a tenth of the $67 billion it sported near the end of 2022.

Mahoney was comfortably positioned as group chair of Johnson & Johnson’s medical device business. But Mahoney saw an opportunity to be a turnaround CEO.

“You have to be willing to run to the fire,” Mahoney said.

He looks favorably upon executives who took on the tough task of turning around a declining division or market rather than leading a large, steady business. “I encourage our people that it’s not always the size of the business that matters, it’s the complexity.”

Kate Stewart, VP and GM of ENT at Stryker, moved from her native Australia to Amsterdam to help manage the growing ENT business. As managing director of the Europe neurosurgery, ENT and craniomaxillofacial businesses, Stewart helped oversee the combination of Stryker’s ENT, Neurosurgery and CMF businesses in Europe. At the same time, the group was growing through M&A and had to integrate ENT products from recent acquisitions of Scopis and Polyganics NV.

“That was through a time of significant transformation,” she said.

“And I knew that not only would our family grow personally by taking on that experience, but professionally, certainly that would be a moment in my career that would really help me learn and grow and become a better leader through the amount of transformation that we had to lead through.”

Tip

2: Get out of your comfort zone

Like Stewart, some executives point to their decision to accept positions outside of their native countries as career accelerants.

(continued on page 104)

Boston Scientific Chair and CEO

Mike Mahoney

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DEVICETALKS

(continued from page 102)

Celine Martin, chair of the Cardiovascular & Specialty Solutions (CSS) Group at Johnson & Johnson, said the global company gave her many opportunities outside her native France.

“I lived in Europe, then moved to the U.S., East Coast [and] West Coast,” she said. “I touched many functions. Big companies. Small companies. Companies that were

acquired and companies that were divested.”

Skip Kiil, president of Medtronic’s cranial and spinal business, spent six years playing professional baseball in the minor league systems of the Phillies, Reds and Yankees before selling medical devices for Stryker. Then, in 2009, he took the post of general manager of Stryker Japan, an international trajectory that would move him and his family to Rome, Geneva and London. A mentor told Kiil that every year spent working in a country where you don’t speak the language is worth three years of experience in a country where you do.

Kiil said leading a business and employees outside the U.S. exposed him to different healthcare markets, physician communities and reimbursement systems.

“You get a good understanding of global healthcare, the policies, and how those policies are executed,” he said. “Universal healthcare is very different than what we operate with here.”

The overseas posts also helped him sharpen his communication skills.

“You’ve got to be concise and consistent with your message because your message is being translated into multiple languages,” Kiil said.

In Japan, for example, Kiil said he spoke enough Japanese to follow conversations, but his success depended upon conveying a simple, clear and focused message that would be passed on by native-speaking subordinates. “You had to be bright, be brief and then be gone,” he said.

Tip 3: Always change at least one thing Martin has spent her entire career with Johnson & Johnson. But the breadth and depth of the large global company afforded her the opportunity to assume many roles in different businesses selling different types of medical devices.

Each new job adds skills to your career “toolbox,” she said, and any career move should change at least one of these variables: job function, company (or a business within a larger company), industry (orthopedics, cardiovascular, and other specialties) or geography.

“When you move, think always about the move afterwards, but try to always move one variable at a time,” she said.

Mahoney moved within companies and changed companies — GE Healthcare, GHX, Johnson & Johnson and now Boston Scientific — when the opportunity was right. But he says changing employers isn’t the point.

“There are great leaders at Boston Scientific who’ve been here for 30 years,” he said. “They’ve always found ways to reinvent themselves. They change divisions, move overseas. They constantly improve themselves.”

Tip 4: Don’t be too humble

Andy Pierce, group president of medsurg and neurotech at Stryker, calls the company a “career playground” that “loves talent and loves giving talented people new experiences as long as you’re engaging in the dialogue and pushing yourself and those around you to be better. That gets noticed in our company, and you’ll get tapped on the shoulder to do more.”

Pierce says part of your careerboosting strategy should be letting your superiors know what your goals are.

“There is a humility gene that runs through Stryker folks and sometimes that humility gene just says, ‘Put your head down and do the right things, and your time will come,’” he said. “Well, most of the time that’s true. But it is a good idea to share your thoughts with your manager.

“Don’t speed,” he warns. “Be great at what you do, understand what great looks like in your role. Go out and get it and make your ambitions known, and things will come along OK. But become a master of your universe. That’s not just learning, but how you have ambition and drive to achieve. That shows up well for people that want to grow in their career.”

Tip 5: Develop resilience Stryker’s Stewart followed career opportunities in London, Amsterdam, San Francisco and now Minneapolis. Each geography presented an opportunity to develop resilience to new workplaces, neighborhoods and customs, she said. The ability to absorb change became even more essential in 2020 when the pandemic unleashed waves of uncertainty.

“What is remarkable to me is how leaders who are successful always make people feel like things are going to be OK,” Stewart said. “… Despite the fact that we may have very difficult decisions to make right now, or that it may feel very unsettled, helping people to feel like things are going be OK in the long run is so incredibly important for us as leaders.”

Go to wtwh.me/careertips for links to listen to these DeviceTalks conversations and more.

Medtronic

Cranial and Spinal President

Skip Kiil

Johnson & Johnson Cardiovascular & Specialty Solutions Group Chair Celine Martin

Stryker Medsurg and Neurotech Group President Andy Pierce

Stryker VP and GM of ENT Kate Stewart

The medical device industry just wrapped up another record year, with more blockbuster mergers grabbing headlines around the world and new, innovative technologies emerging seemingly every day.

This level of success wouldn’t be possible without the innovation, ingenuity and determination of the people who drive it: leaders. These individuals and companies are working for the growth of the entire medical device industry.

The future of medtech will build on the foundation of today’s efforts. Medical Design & Outsourcing

like to acknowledge such

the following pages.

QUALITY, EXPERTISE AND INNOVATION

As the largest electropolishing specialist in the United States, Able Electropolishing has spent six decades at the forefront of innovation in electropolishing to eliminate defects and improve the surface finish of critical metal parts, with microscopically precise and consistent results.

In close collaboration with clients in the aerospace, medical, laboratory, pharmaceutical and food processing industries - among others - Able has developed highly customized processes that produce the most precise, consistent and reliable results for a wide array of critical metal parts, with benefits that include:

• Deburring

• Ultracleaning

• Resistance to Bacterial Growth

• Microfinishing

• Fatigue Life Improvement

• Improved Corrosion Resistance www.ableelectropolishing.com

Prototyping Collaboration

Puts Finishing Expertise to Work at the Start

Nitinol wire

The Able Difference

And while we play a vital role as the “last step” in the process for many critical metal parts, we also use our metal finishing expertise to improve parts from the start by consulting in the design and prototyping stage. Our “Finish First” methodology helps clients avoid design flaws that can trap debris and liquids and impede the ability to create the highest quality surface finish.

Commitment to Our Customers

Our commitment to our clients’ success drives our work toward continuous innovation, down to the customization of our processes for each part, including on-site tooling, custom racking, custom chemical formulation and prototyping runs conducted on full production equipment. We treat every single job as the critically important step that it is and our roster of clients worldwide shows the level of trust that we have earned over six decades of providing state-of-the-art solutions and unmatched customer service.

We’ve earned the trust of engineers and manufacturers in some of the most challenging industries in the world. That takes more than innovation and state-ofthe-art processes. It also means an attention to deadlines, efficiency, reliability and a tradition of continuous improvement. Our clients depend on us for jobs with no room for error. You can too.

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Voting for this company will identify it as a leader in the medical technology industry.

Accumold began in a rented garage in 1985. Our primary focus was and still is on very small micro-sized plastic parts and components that other companies can’t produce. The original Micro-Molder® was designed to help manufacture parts with minimal waste and short cycle times for electronic component manufacturing. Although there have been many innovations over the years the basic principals have remained the same and so has our commitment to micro-injection molding technologies.

Today the company now focuses on industries that require fast turn around and complex parts for high tech industries such as Micro Electronics, Micro Optics, and Medical, as well as new emerging markets and technologies.

Micro-Mold®

These minute parts are often measured in microns and are no bigger than 0.5 cubic inches; they typically weigh less than a gram. In addition to their size, these parts have very tight tolerances and must be molded efficiently and precisely — time and time again.

Accumold builds specialized molding machines for this unique capability. The machines are engineered to handle volumes from prototypes to millions per year while maintaining consistent, precise tolerances that are unique in the industry. The specialized tooling and molding for micro-sized components are only available at Accumold.

Accumold

1711 S.E. Oralabor Road Ankeny, IA 50021

P: 1.515.964.5741 F: 1.515.964.5742 accu-mold.com

Small Parts

Not every micro-molded application requires microscopic parts, but many require demanding geometry and tight tolerances on a slightly larger scale. Micro-features — incorporating very small features on a normal-sized part up to about 3 inches in diameter — are another of Accumold’s capabilities.

Lead Frame / Insert Molding

Insert micro-molding involves molding in or around a wide variety of materials such as plastic, ceramic, glass, fabrics, film or foil. This type of over-molding can be achieved on either the Micro-Mold® or Small Mold platforms with the same high-precision output. The process can be operator loaded or our Automation Team can build a custom loading system for high-volume applications.

Facilities

Accumold is an ISO 13485, 9001 and 14001 certified company with a state of-the-art, 130,000 square foot production plant. The Accumold facilities are located near Des Moines, IA, in the heart of the Midwest. The building is climate controlled and includes six 100K clean rooms and three 10K clean rooms for micro-electronics and medical applications.

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Voting for this company will identify it as a leader in the medical technology industry.

Metal Injection Molding & 3D Metal Printing

Manufacturing small, intricate, high-volume components is often costly and hard to scale. At Advanced Powder Products, our proprietary technology harnesses the power of metal injection molding to maximize the performance of your design. Medical device companies need a reliable supplier for all their small and complex metal parts. In order to achieve that sort of relationship, questions often need to be answered surrounding capacity, supply chain, prototyping, qualifications, and more. The manufacturing process is undeniably technical and complex, but finding the right partner shouldn’t be.

For over 20 years we have been pushing the boundaries of MIM and binder jet 3D printing to produce precision, complex, net-shaped, highdensity components for the medical device industry. We know how difficult it is to engineer components that meet print which is why we work with you to balance the dueling needs of budget and quality so that you get the best outcome.

Advanced Powder Products, Inc. 301 Enterprise Drive Philipsburg, PA 16866 advancedpowderproducts.com

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Voting for this company will identify it as a leader in the medical technology industry.

APP’s expert team of metallurgists, engineers, and production staff focus on innovation, quality, and performance so that you can feel confident in your design from prototype to production. Bring your application to market by incorporating APP’s proven technology platform. Whether your product is in design or production, APP’s technology can fit your needs.

AllMotion Inc. develops and manu-factures

miniature high-performance stepper and servo drives for the medical, scientific, optical and general automation markets. Their mission is to create superior, ultra-compact motion control solutions that reduce costs and readily integrate into OEM instrumentation designs across a wide range of industries. R&D efforts are centered on core competencies of small form factor components that deliver precise positioning control and ease of use.

AllMotion provides off-the-shelf motion control devices and custom solutions based on their EZStepper and EZServo motor driver technology. Their servo motor controllers and brushless DC motor controllers feature quadrature encoder feedback, and are programmable to allow standalone operation. Based in San Jose, California, the company has proven leadership in miniature motion control, with a full line of intelligent driver/controllers.

The EZQuad Servo was designed to allow the rapid implementation of multiaxis stepper motor solutions in products requiring automation.

Measuring only 2.25” x 2.25” X 1.0” (57mm x 57mm X 25mm), the fully intelligent servo motor Controller + Drivers runs 4 fully independent Brushed or BLDC servo motors. Operating from a 7V to 40V supply, the controller regulates to any motor voltage via software command (e.g., 3V motor can be run with 24V supply). Commands can be issued from any serial terminal program (such as HyperTerminal) or from the EZStepper Windows application.

The EZQuad Servo will drive 4 motors at 2.5 Amps each with a setting of move current m=50 %. However, with careful selection of motors and/or improved cooling and/ or low move time duty cycle, it is possible to run motors at 5 Amps at m=100%. See Command Set for details.

Command

All Motion, Inc. 30097 Ahern Avenue Union City, California 94587 Sales Office - 510.471.4000 Technical Support - 408.460.1345 Fax - 408.358.4781 Email - support@allmotion.com www.allmotion.com

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Set for details.

The Commands are intuitive and simple. For example, the command A10000 will move the servo motor to Absolute position 10000. (This communications protocol is compatible with devices that use the Cavro DT or OEM protocol.)

The EZQuad Servo is also capable of standalone operation with no connection to a PC. It can be set to execute a preset string of commands upon power up (i.e., only power is required in this mode). The Commands include nested loops and execution halt pending a switch closure, which is useful in stand-alone applications.

The EZQuad Servo Motor Controller will typically work with any motor that is 3” or smaller (size23 or smaller). Starter Kits enable a first time user to make Servo Motors move intelligently in less than half an hour.

ALTECH - COMPONENTS FOR MEDICAL DEVICE DESIGNS

Serving automation and control industries since 1984, Altech’s products meet UL and international standards and all are RoHS and REACH compliant. Altech’s commitment to quality have been recognized since May 27, 1999 when they were awarded the prestigious honor of ISO 9001 certification and maintains a ISO 9001:2000 certification today.

Product lines include miniature circuit breakers, busbars, DC-UPS devices, digital panel meters, terminal blocks, enclosures, contactors, many types of relays including safety relays, motor disconnect switches, strain reliefs, receptacles, foot switches, push buttons and pilot lights. Many other products are also available.

Altech Corporation is an established USA supplier of components and devices used in industrial control, instrumentation and automation. It is an ISO 9001:2000 certified manufacturer and distributor of electrical, electronic and electromechanical components.

Altech provides many services. This begins with its product managers, providing technical support and partner with customers in design assistance, ensuring the best solutions. The Customer Service Department ensures that customers are informed with complete order information. The versatile assembly department provides manufacturing, value added or customization services to expedite delivery. The marketing department has been highly recognized for its catalogs, advertising and website, while the sales department motivates over 25 manufacturer representative companies throughout North America, ensuring product information is complete.

Altech 35 Royal Rd. Flemington, NJ 08822 www.altechcorp.com

The product line includes miniature circuit breakers, busbars, DC-UPS devices, panel meters, terminal blocks, contactors, motor discon¬nect switches, pin & sleeves, receptacles, foot switches, many types of relays, push buttons & pilot lights. Also available are metal detection systems, ferrules, marking & engraving systems, fuses, power distribution blocks, tubing, liquid tight strain reliefs, timers, test & measurement, LED panel lights, thermostats, panel filters, tower lights & wire ducts. Altech’s products meet UL and many international standards and all are RoHS compliant.

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Bring YOUR Message to Life

ARTERY STUDIOS has specialized for 30 years in the creation of engaging medical animations and illustrations –striking visuals to promote existing and developing products, educate health care professionals, inform patient audiences, drive tradeshow marketing, and bolster social media messaging.

With every one of our illustrators and animators holding master’s degrees in biomedical visualization, we partner with our clients to showcase your medical device or biomedical concept with crystalclear medical visuals.

Animate your innovation in a way that’s impossible to ignore – bring your message to life with ARTERY STUDIOS.

Artery Studios, Inc. 22 W. Washington St. Suite #1500 Chicago, IL 60602

https://arteryhealthcarevisuals.com

ARTERY STUDIOS is a leader in showcasing biomedical breakthroughs with eye-catching and informative medical animations and illustrations. We are a team of specialized medical illustrators & animators, trained at accredited medical school programs. With an MD on staff and our deep knowledge of, and specialization in, biomedical depictions that ‘translate’ complexity into clarity, Artery Studios elevates your communications for enhanced outcomes.

We create visuals for numerous medical purposes – to advance healthcare; attract investment capital; boost corporate messaging; demonstrate cutting-edge medical innovation; market established products; educate audiences from laypeople to specialized physicians; clarify complex scientific concepts, and more.

We’re known for the clarity of our medical illustrations and the other media we create. We believe that accuracy is paramount and must be fully integrated with beautiful and engaging visualizations to appeal to the viewer – to grab attention and make the key message strike home.

“Artery Studios is [the] type of creative partner that every med-tech company needs… [their] attention to detail and commitment to “getting it right” will satisfy the most discriminating client. Artery Studios are experts in breaking down complex technologies through customized animation and eye-catching graphics.”

Rob Berman CEO, enVVeno Medical

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If you need a trusted outsourcing partner for medical device and pharmaceutical contract manufacturing, turn to B. Braun’s OEM Division — a division of one of the world’s leading health care companies. Whether you are looking for a solution, medical device, fluid administration set, custom kit or individual components, we can provide the products and capabilities to meet your needs.

Our dedicated project management teams have the expertise to turn your ideas into reality.

B. Braun’s OEM Division

B. Braun Medical Inc. 861 Marcon Boulevard Allentown, PA 18109 1.866.8.BBRAUN (1.866.822.7286) us.bbraunoem.com

For more than 175 years, B. Braun has worked to protect and improve the health of people around the world. With thousands of pioneering achievements in medical device and pharmaceuticals, the family owned company remains at the forefront of innovation. The OEM Division operation has been part of B. Braun for over 30 years.

Every day, over 64,000 B. Braun employees worldwide share their expertise with colleagues and customers to enhance safety for patients, doctors, and nurses, and to improve working processes in hospitals and medical practices.

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Propelled by our philosophy of Sharing Expertise®, B. Braun Medical Inc. is a leader in infusion therapy, pain mangement technology, and support services that meet the highest standards for quality, safety, sustainability, and efficiency.

The B. Braun Group of Companies has global headquarters in Melsungen, Germany and operations in 64 countries. In the U.S., B. Braun Medical’s corporate headquarters is located in Bethlehem, Pennsylvania with manufacturing facilities in Allentown, Pennsylvania, Irvine, California, Daytona Beach, Florida, and the Dominican Republic.

BAYCABLE Interconnect Solutions

Our specialty is working with clients to design application specific solutions to complex interconnection problems that are solved by our capability to manufacture custom cable, coil cords, molded cable assemblies and electromechanical sub-assemblies in Fremont, California and Sonora, Mexico.

SPECIALTIES:

• Silicone and Thermoplastic Molding & Extrusion

• In House Cable Manufacturing

• In House Mold Tooling

• Very Fine Wire Termination

• Custom Connector Design

MARKETS:

• Medical

• Industrial

• Automotive

• Audio

Bay Associates Wire Technologies 46840 Lakeview Blvd Fremont, CA 94538 510-933-3800 bayinfo@baycable.com www.baycable.com

BAYCABLE is vertically integrated and can offer a wide range of manufacturing capabilities including custom cable constructions, full turnkey cable assembly and molding services, component customization, specialized testing, and in house mold tool manufacturing.

BAYCABLE delivers unparalleled engineering expertise “an integrated solutions partner” that can help skillfully create the optimal interconnect system for your application.

Early design collaboration with our Silicon Valley based engineering group takes you from concept through pre-production into the initial production runs quickly, and we provide medium to higher volume production by transferring production to our plant in Sonora, Mexico. Both manufacturing locations are ISO Registered.

BAYCABLE has a long legacy of delivering high performance reliable interconnect solutions to our customers.

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Global Full-Service Hydrophilic Coatings Provider

Biocoat is a leading full-service hydrophilic coating provider specializing in supplying lubricious hydrophilic coatings, custom coating services, and coating equipment for medical devices. Biocoat is the only hydrophilic coatings provider to offer industry-leading performance in both Thermal and UV light coatings. Our service team creates unique solutions that offer high-touch services from your discovery phase through delivery. Biocoat also offers EMERSE®, an automated dip coating system designed for medical device companies that require high-quality and reliable technology to coat their devices in-house. EMERSE is available for both UV and Thermal curing options.

Biocoat Incorporated 123 Rock Rd Horsham, Pennsylvania 19044 http://www.biocoat.com

For over 31 years, Biocoat has partnered with the world’s largest manufacturers and some of the most innovative and exciting start-ups companies as a coating partner, an R&D asset, and a manufacturing arm. Being a global leader in hydrophilic coatings, we offer high performing, custom, lubricious, abrasion-resistant, and biocompatible hydrophilic coatings that can be applied to a wide range of polymeric and metallic substrates using either a Thermal or UV curing technology to meet your design parameters. Providing a complete solution goes beyond simply providing a product. In addition to the industry’s top-performing coatings, Biocoat also offers a turnkey solution that enables your medical devices to be expertly coated using our HYDAK® technology with a Thermal or UV cure. Our comprehensive ISO 13485-2016 Contract Coating Services for medical devices is specifically designed to

ensure that your products will be expertly coated for maximum safety, maneuverability, and patient comfort. To complete the development and launch of medical devices that use hydrophilic coatings, Biocoat offers hydrophilic dip coating equipment to support both high and low volumes of coating, is a true full-service

hydrophilic coatings provider and your one-stop shop for all things hydrophilic. With Biocoat’s full-service offering, our coating experts will be able to find the perfect solution for your project.

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BMP Medical provides plastic contract manufacturing services to leading medical device and diagnostic OEMs in need of injection molding and injection blow molding contract manufacturing services. We help customers in the Medical & Diagnostic markets bridge their capability gaps and accelerate their go-to-market success. We foster strong trust-driven relationships to develop inventive solutions tailored to customers and end-user needs. From concept through commercialization, BMP offers in-depth problem solving backed by deep industry knowledge and operational excellences.

What makes BMP Medical different from other companies?

A culture that promotes continuous improvement, respect for humanity, and an optimal results-driven approach—all of which benefit leading medical device and diagnostic OEMs, the employees, and the company. Our continuous improvement approach can be seen in our expanded capabilities within our 80,000-square-foot manufacturing facility and in our commitment to implementing internal training programs with an eye to benefiting our valued customers.

Services:

• Custom Injection Molding

• Custom Injection Blow Molding (IBM)

• Clean Room Manufacturing (Class 8)

Markets Served:

BMP Medical is a global contract manufacturer servicing the Medical Device and Medical Diagnostic markets in all areas, including, but not limited to, IVD, IV access, sample-preparation devices, and lateral-flow technologies. Headquartered in Sterling, MA, and with global manufacturing capabilities in Asia, BMP Medical can service partner requirements on a worldwide basis.

Quality Systems:

• ISO 13485:2016

• FDA 21CFR820

BMP Medical

16 Chocksett Road

Sterling, MA 01564

Phone: 978-632-2555; toll-free: 800-253-3684 Fax: 978-632-2524

E-mail: sales@bmpmedical.com Web: www.bmpmedical.com

• Clean Room Packaging & Assembly

• Product Design & Development Services

• Sterilization Services

• Custom Packaging

• DNase- and RNase-free manufacturing

• FDA Registered Facility

• Class 7 Assembly

Capabilities:

• Design Consultation

• Engineering Consultation

• R&D Tooling

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• CAD Design

• Statistical Process Control

Cadence, Inc. is a single source contract manufacturing partner for medical device and diagnostics companies worldwide.

Cadence provides end-to-end product realization solutions focused on best-in-class total value. Cadence employs over 550 people with headquarters in Staunton, VA and other locations in Connecticut, Pennsylvania, Rhode Island, and Wisconsin.

Major Markets Served: Analytical Science Cardiology Drug Delivery Point of Care

IVD Fluid Delivery Interventional Therapy Neurology Biopsy Diagnostics Endoscopy Pharmaceutical Orthopedics General Surgery Minimally Invasive Surgery Opthalmology

Cadence, Inc. 9 Technology Drive Staunton, VA 24401 sales@cadenceinc.com Tel: 540.248.2200 Fax: 540.248.4400 cadenceinc.com

What makes Cadence different from other companies? Cadence is all about improving product performance and economics. We help develop new products that other cannot, build processes that other will not, and deliver outcomes that simply make the world work better. We use integrated and advanced technologies to make finished devices as a single, turnkey manufacturing partner for medical device OEMs.

Cadence offers complete services that range from initial design through manufacturing and full supply chain management for single use and disposable medical devices.

• Design Services

• Rapid Prototyping

• Certified Cleanroom Manufacturing

• Finished Device Assembly

• Complete Supply Chain Management

• Final Packaging and Labeling

• Sterilization Management

We also provide a very broad set of core capabilities that are competitive and differentiated in the marketplace. Unlike most contract manufacturers, we also have significant metals and plastics expertise; making new products a reality.

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Metals Expertise:

• Advanced Welding Lab™

• Micro Machining & Swiss Machining

• Laser Welding, Cutting, & Marking

• Tube Fabrication including LaserSwiss

• Sharps – Specialty Blades & Needles

• Precision Metal Stamping

• Microstamping & Multi-slide Stamping

• EDM – Wire, Ram, & Sink

• Nitinol Shape Setting

• Custom Automation

• IncisionLab™

Plastics Expertise:

• PEEK Machining

• Cleanroom Molding

• Engineered Resins Expertise

• Sharps Molding & Handling

• Reel-to-Reel Molding

• Plastic Injection Molding

• Insert Molding

• Micro Molding

Precision Designs “MOVE”

Our compact DC motors, developed in 1962, for use in Canon 8-mm movie cameras, have been further refned for use in audiovisual devices, single-lens reflex cameras, office equipment, and other applications. The scope of application for these motors has continued to expand, and they can now be found in product categories subject to high demand, including camera lenses, laser printers, large format printers, industrial machinery, analysis equipment, cash machines and medical devices.

Today, Canon USA uses that advanced technology to propose customized solutions to meet all kinds of customer needs. Our flexibility in design, allows us to work closely with each customer to provide the exact solution required, be it simple or complex.

Our product lines include brushless DC servo motors, brushless motors, coreless motors, frameless motors and linear ultrasonic piezo motors as well as optional equipment such as gears and encoders. In addition, our simulation technologies enable us to offer actuator units and other essential parts to meet the needs of a wide range of customers.

Energy-efficient small motors have the advantage of consuming little power, which makes them the popular choice of industries worldwide. By offering the unique ability to customize our products, we remain committed to meeting customer needs.

Canon U.S.A., Inc.

3300 North First Street San Jose, CA 95134 United States https://www.usa.canon.com/business/industrial/ dc-motors

Brushless DC Servo Motors: Achieves Best-in-Class torque and compactness BLDC, compared with other Canon motors. Applications include Gantry Robots, SCARA Robots, and Surgical Robots etc.

Frameless Motors: Canon’s frameless motors are lightweight and high-performance in compact size. These built-in type frameless motors enable space-saving installation and flexibility in mechanical design. Size, voltage, speed, shaft type and rotor type can be customized based on a customer’s request.

Linear Ultrasonic Piezo Motors: Canon’s linear ultrasonic piezo motors are compact, quiet and accurate for linear positioning applications. Canon has been using this technology for driving focus lens in camera products. Applications include Medical, Scanning electron microscope (SEM) and Optical devices.

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We’re more than medical device manufacturing

Canon Virginia works with companies to bring together innovative technologies, ideas, and processes to make meaningful impacts in medical manufacturing, device development, and beyond. Whether device development, manufacturing and engineering services, or support services, we’re uniquely equipped to be an outsourcing partner.

Canon Virginia is ISO 13485:2016 and MDSAP certified as well as FDA cGMP compliant for medical manufacturing. We have the skills and facility to support Class I, II, III medical device manufacturing. In addition, Canon Virginia is ISO 9001, 14001 certified, and EAR/ITAR compliant.

Canon Virginia, Inc.

12000 Canon Blvd Newport News, VA 23606 United States www.cvi.canon.com/mfg

As the manufacturing and engineering center for Canon in the Americas, Canon Virginia can tap into processes and insights from the global Canon network and apply them to customer challenges. With hundreds of engineers and a broad range of skill sets, we’re able to produce everything from single parts to complex products for medical image/optics and microfluidics manufacturers.

Canon offers an extraordinary range of services, including: Product Design, Prototyping, Design for manufacturing, Injection mold making, Design transfer, Manufacturing process development and validation, Risk management, Medical molding, Quality management systems, Component and subassembly manufacturing, Logistics, Financial Services, and Service & support.

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Mechanical Cable for Surgical Applications

The world trusts Sava’s mechanical cable to power tomorrow’s surgical robots and endoscopic instruments. That’s a fact.

For over 50 years, Carl Stahl Sava Industries has been a staple in the manufacture of world-class surgical robotic, endoscopic device, implantable and wearable mechanical cable and assemblies. Using materials such as tungsten, stainless steel, nitinol, titanium and more, Sava has taken the time and invested greatly in perfecting the ultrafine cables powering the motion systems of the world’s most advanced surgical marvels.

Working alongside the most trusted names in contract manufacturing and surgical instrumentation innovation, Sava has a deep bench of experts with decades of collaborative experience.

Carl Stahl Sava Industries makes the most sophisticated surgical mechanical cable and assemblies on Earth. What make Sava a special maker of ultrafine mechanical cable assemblies is our commitment to meeting the complex needs of surgical robotics and medical devices makers. Sava has invested millions deploying the talent and technology required to satisfy the most discerning surgical device makers. Combined with our deep bench and state-of-the-art equipment, Sava also applies the most modern lean and cellular manufacturing processes, and honors 5S practices across all facets of production. What’s more, Sava’s quality experts ensure customers receive products that meet and often exceed rigorous regulatory, tolerance, strength and lifecycle requirements.

But even with the right people and tools, the right attitude is what differentiates Sava from alternatives. Sava understands the engineers that design tomorrow’s next surgical innovation. After all, we talk to them all day, every day.

4 North Corporate Drive Riverdale, New Jersey 07457 www.savacable.com

With Sava, device makers have a partner that understands the often-protracted R&D exercise undertaken. That’s why Sava has developed manufacturing processes that allow us to move in lockstep with our customers through every phase of production. Any revision, big or small, frequent or rare, as well as course corrections like a change in cable material, testing parameters or even scheduling are all managed with an eye on ensuring goto-market planning goes uninterrupted.

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Carl Stahl Sava Industries

LARGEST MINIATURE-GUIDES SUPPLIER IN THE WORLD

Chieftek Precision USA of Chieftek Precision Co. Ltd. (cpc) is a manufacturer of complete linear-motion mechatronic solutions, including profile linear guides, linear motors, compact linear stages, servo drivers, XYZ tables, and gantry systems for automation machine tools and robotic industries. With distribution centers in California, cpc provides rapid and first-rate service to American customers — offering German quality with Taiwanese flexibility, prompt delivery, and competitive pricing. guides

Chieftek Precision USA of Chieftek Precision Co. Ltd. (cpc) supplies linear guides, directdrive tables, linear motors, feedback components, and servo drives backed by a team of managers, engineers, and technicians dedicated to the R&D and manufacture of top-quality linear-motion components.

Chieftek MR Series linear guides excel in precision measurement and inspection applications; ARC guides are widely used in machine tools; HRC and ERC guides complete heavily loaded axes; and RR linear guides with roller bearings deliver top performance in general motion designs.

Chieftek Precision Co., Ltd (cpc) www.chieftek.com

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Chieftek P Series ironless linear motors have the highest thrust density and efficiency of their kind. C Series iron-core linear motors deliver high thrust with low cogging. For users familiar with belt and ballscrew-driven systems, Chieftek packages its linear motors into CLS/CLMS compact linear stages that integrate linear motor, guide, and positioning.

Chieftek packages

Engineers can also source servo drives from Chieftek. The Will1 Series features high power density, easy-to-use autotuning, and advanced features to let machine builders create breakthrough products. The low-voltage Chieftek Will1-D accepts 48-Vdc input to 30 A continuous. It features an ultra-small size and high power density — and is suitable for AGVs, drones, and robot applications; Will1-B drives support all standard encoder formats.

Most recently, Chieftek introduced the UF-30-09 ultra miniature linear-motor stage. With thickness to 9 mm and acceleration to 3.5 g, the stage excels in electronics assembly (SMT), medical pipetting, and other multi-head applications where space is limited.

Outsourcing Solutions for Complex Medical Devices

As a vertically integrated, full-service outsource partner, Cirtec specializes in today’s most innovative product technologies. We bring over three decades of expertise to every phase of the product development lifecycle including state-of-the-art product design, development, and manufacturing capabilities. From active implantables to interventional devices and delivery systems, Cirtec can assist with pilot/ clinical builds to full scale production. Our systems are ISO 13485 certified to ensure consistent quality management for your components and finished devices.

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. We have the expertise needed to design innovative devices, solve complex design challenges, and help bring devices to market.

Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring your product to full production, including assembly, packaging and testing, and in-house sterilization.

Our core competencies include:

• Active Implantables

o EE, SW, firmware, RF design

o IPG assembly

o Orthopedic smart implants

o Leads design and assembly

• Catheters & Delivery Systems

o Complex, steerable o Balloons, balloon catheters

o Braiding, coiling

o Multi-lumen extrusion

• Circuits & Sensors

o Application Specific Integrated Circuits (ASICs)

o Printed circuit board assembly o Thin-film circuits

Cirtec Medical 9200 Xylon Avenue North Minneapolis, Minnesota 55445 United States www.cirtecmed.com

• Nitinol Tubing & Processing

o Implant quality tubing

o Highest fatigue life for heart valve cages

o Peripheral vascular tubing o Laser cutting, heat setting, electropolishing

• Precision Metals

o Machining and Swiss turning o Stamping o Wire EDM

o Coil winding

o Laser cutting and welding

• Silicone Molding & Extrusion

o LSR molding

o HCR molding

o Extrusion

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o Assembly, subassembly

Cirtec is committed to being the preferred outsourcing partner for providing innovative solutions for your life-enhancing therapies.

CLIPPARD PRECISION FLUID CONTROL PRODUCTS & SOLUTIONS

Clippard provides thousands of standard and special precision flow control products to design engineers and manufacturers around the world. Clippard’s expertise is not limited to providing over 5,000 standard products, but also offers a unique advantage by providing custom products and value added assemblies for hundreds of applications.

Products include:

• Electronic Pressure Controls

• Electronic valves, standard and proportional isolation

• PTFE and PEEK Isolation valves and pneumatic or electronic pinch valves

• Precision flow controls

• 7, 8, 10 and 15 mm electronic valves

• Fittings and tubing

• Value-added custom assemblies

• Special components and systems designed for customer’s OEM applications

For over 75 years Clippard has been manufacturing and providing products and solutions to design engineers and manufacturers in a wide variety of industries including drug dispensing, laboratory equipment, medical devices, material handling, analytical, chemical analysis, sampling, life science/biotech, genetic research, gas chromatography, spectrometry, DNA synthesizing, blood analyzing, printing, diagnostic equipment, fermentation, packaging, water treatment and more.

Miniature Pneumatic Products & Solutions

Web

Visit www.clippard.com to find complete product information, engineering drawings, technical specifications, full color photos, CAD files, order information, literature downloads, helpful calculators, technical assistance, distributor information and more.

Quality

Quality remains a primary feature of every product Clippard produces. This is achieved through the excellence in manufacturing practices and craftsmanship that has continued throughout the years. The high standards set by Leonard Clippard, in company relationships with customers, distributors, suppliers and employees continue to be upheld. The company motto, “Quality People, Quality Products”, emphasizes the important role every employee plays in maintaining the company’s reputation.

Catalog

Clippard offers a full-line catalog which contains over 5,000 standard products. Call today for a free copy.

Applications

Today, Clippard pneumatic control devices are used virtually everywhere for control, interface, sensing, logic and actuation functions. For medical, analytical, laboratory, diagnostic and other related applications, Clippard manufacturers precision components including oxygen clean, analytical and proportional valves, PTFE and PEEK isolation and pinch valves, precision regulators, manifolds and more. Custom products and assemblies for specific applications are also welcomed.

Distributors

Clippard products are sold through a worldwide distributor network that offers products plus design engineering expertise.

Clippard

7390 Colerain Avenue

Cincinnati, Ohio 45239 877-245-6247 www.clippard.com

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Components Corporation is the global leader in the design, manufacture and engineering of innovative precision printed circuit test points, wireform interconnect and testing solutions, printed circuit card edge connectors, preform jumpers and hardware, and battery contacts.

We remain committed to solving the industry’s most demanding wireform interconnect and testing challenges with high-quality and innovative products for the broadest range of mission-critical applications. Our industrial, military and commercial customer base has come to rely on Components Corporation to ensure the excellence and economy of products regardless of the quantity required. Our products are marketed through a worldwide network of sales representatives and distributors.

Components Corporation: Redefining Innovation in Interconnect Solutions

At Components Corporation we design, manufacture and engineer a standard line of innovative PCB test points, card edge connectors, preform jumpers, and battery contacts.

But if a standard product doesn’t suit your design requirements, take advantage of our innovative custom wireform services for the right solution to your most challenging interconnect applications.

Our advanced skills in the custom wireform manufacturing of precision alloy materials to strict specifications has resulted in a variety of specialized wireform products for the electronics packaging industry worldwide.

Given basic requirements or dimensions, Components Corporation will deliver an economical, perfectly-functioning part that’s compatible with the parameters of our machinery. A unique feature of both our custom wireform and standard products is their ability to function in a broad range of conditions. Our products are ROHS and REACH compliant.

Our In-house capabilities allow us to custom manufacture wireform interconnect products such as connector contacts, spring contacts, test points, terminals, jumpers, retaining clips, ground clips and shielding contacts for any board application. With roots as an R & D company we’ve earned our “no failure” reputation by solving a range of stringent design challenges.

Components Corporation is committed to supplying the products that suit your requirements, and we provide product samples upon request. A strong team concept and the ability to anticipate the changing needs of our customers with innovative solutions has positioned Components Corporation as a leader in custom wireform manufacturing. Contact us for more information!

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COMSOL is a global provider of simulation software for product design and research to technical enterprises, research labs, and universities. Its COMSOL Multiphysics® product is an integrated software environment for creating physics-based models and simulation applications. A particular strength is its ability to account for coupled or multiphysics phenomena. Add-on products expand the simulation platform for electromagnetics, structural, acoustics, fluid flow, heat transfer, and chemical applications. Interfacing tools enable the integration of COMSOL Multiphysics® simulations with all major technical computing and CAD tools on the CAE market. Simulation experts rely on COMSOL Compiler™ and COMSOL Server™ to deploy applications to their design teams, manufacturing departments, test laboratories, and customers throughout the world.

COMSOL, Inc. 100 District Avenue Burlington, MA 01803

Phone: +1 781 273 3322 Fax: +1 781 273 6603 E-mail: info@comsol.com www.comsol.com

Highly accurate simulation of the human body and its interaction with medical devices is driving a shift toward in silico device trials of new therapeutics in the medtech industry. The COMSOL Multiphysics® software is critically important to understand and predict the performance of a device through the software’s multiphysics capabilities for the modeling of physiology, different physics of processes in the human body, and their complex interactions. Applications include the modeling and simulation of ablation systems, hearing aids, stents, hematology analysis, MRI, implantable devices, glucose sensors, ultrasound imaging products, peristaltic pumps, electrical sensors, piezoelectric valves, and more.

Simulation of a rapid test strip showing how the sample flow develops.

Simplified human head and brain model created with COMSOL Multiphysics® for the calculation of specific absorption rate (SAR)

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Applying Materials Science to MedTech Innovation

Confluent Medical Technologies applies materials science to MedTech innovation. Confluent specializes in expert design and development of large-scale manufacturing specializing in interventional catheterbased devices and implants. Our key capabilities include Nitinol tubing and components, balloon and complex catheters, high-precision polymer tubing, and implantable textiles. We operate in 8 state-of-the-art facilities across the United States and Costa Rica and currently employ over 2,000 employees.

Confluent engineers solutions to the most challenging design problems enabling our OEM medical device customers to offer lifesaving products. Our vertically integrated supply chain offers expert design, development, and large-scale manufacturing specializing in interventional catheter-based devices and implants. With over 30 years of experience, we ensure that every project is supported by our unmatched capabilities in Nitinol tubing and components, balloon expandable stents and catheters, biomedical textiles, complex catheters, and high precision polymer tubing. Our U.S.-based capabilities offer security and stability to our Nitinol supply chain and our

Confluent Medical Technologies 6263 N Scottsdale Rd Suite 224 Scottsdale, AZ 85250

https://confluentmedical.com/

High Precision Polymer Tubing Center of Excellence offers Filmcast PTFE within 4 weeks or less. Our position as a leader in contract manufacturing of medical devices keeps us at the forefront of the industry and well-equipped to serve medical device companies seeking partnerships for their engineering, manufacturing, and production needs. With 8 state-of-the-art facilities across the United States and Costa Rica and over 2,000 employees, Confluent has earned the confidence of leaders in the medical device community through a proven track record of innovation, engineering, and manufacturing.

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Contract Manufacturing & Engineering Services

Cretex Medical provides medical device manufacturing and engineering services. Our family of companies (rms, QTS, and our newly formed CDT group) specialize in a broad range of outsource services, including metal and plastic machining, additive manufacturing, custom instrument manufacturing, injection molding, precision metal stamping, laser processing, finished device assembly, sterile packaging, sterilization management and design & fabrication of cases & trays, chassis and metal enclosures.

We offer a complete range of end-to-end manufacturing capabilities, the latest technologies, and the talent to match any engineering or manufacturing challenge. You have a partner in us who can grow with your business, backed by a strong financial portfolio and long-term perspective.

Making It Easier to Get Your Products to Patients

Major Markets

Services Offered

Cretex Medical Multiple locations. HQ in Minnesota. Email: info@cretexmedical.com www.cretexmedical.com

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Delivering Scalable Solutions for What’s Next

Since 1985, Digi International Inc. (Digi) has been a pioneer in wireless communication, forging the future for connected devices and responding to the needs of the people and enterprises that use them.

Before the Internet of Things was a thing, we built M2M and IoT devices, adapted to evolving network standards, and optimized data communications around the most advanced protocols and emerging technologies. From radio frequency modems to gateways, cellular routers, networking devices, embedded systemon-modules (SOM) and single-board computers (SBCs), Digi’s solutions have continually grown to serve the full breadth of applications across the IoT landscape.

Today, our IoT offering includes sensor-based solutions, a sophisticated platform for remotely monitoring device deployments of any size, anywhere, as well as professional design, implementation and certification teams to help you carry out your vision, no matter how large or small.

Digi ConnectCore® embedded system-onmodules (SOMs) are complete solutions used by medical device companies worldwide, providing integrated wireless connectivity, in-depth security, extensive developer tools, and unparalleled quality and reliability.

Digi leads with integrated, secure, and pre-certified wireless connectivity on ConnectCore SOMs. The latest ConnectCore MP1 includes an ARM® Dual Cortex® A7 from ST Microelectronics with integrated Wi-Fi 5 (802.11ac) and Bluetooth® 5.0. New SOMs released later in 2023 will be among the first with Wi-Fi 6 support.

Digi has recognized the importance of device security with our integrated Digi TrustFence® security framework, offering powerful, easyto-implement technology features that support end-to-end data encryption for compliance with HIPAA and other regulations worldwide.

In 2023, Digi introduces our innovative ConnectCore Security and Cloud Services, designed to provide monitoring of evolving security vulnerabilities after devices are deployed, and a sophisticated mechanism to manage deployed devices with secure overthe-air software updates.

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Digi pioneered Surface-Mount SOM technology, and our patented SMTPlus® form factor makes the ConnectCore MP1 the smallest wireless SOM available, ideal for handheld and portable medical devices, where size and low-power operations are crucial.

Industrial grade components, extensive testing and certifications, with an industryleading 3-year warranty and 10-year (minimum) availability enable rapid medical certifications and long product lifecycles, with the quality required for medical devices.

Founded in 1985, Digi is a publicly traded company (NASDAQ: DGII) with revenue of $388 million in their 2021 fiscal year. Headquartered in Hopkins, Minnesota, Digi has regional sales and engineering offices throughout North America, Europe, and Asia.

Digi International Inc. contact information and web address

Digi International

Delivering stainless steel, high nickel alloy components to customers in the medical, aerospace and industrial industries. Stainless steel is a commonly used material in applications ranging from medical instruments, chemical storage, transportation of liquid and gasses and other industrial applications.

Just as not all stainless steel grades are created equal, neither are stainless steel tubing suppliers. As an experienced stainless steel tubing supplier, Eagle can provide guidance about both standard and custom options. Since 1982 Eagle has been offering custom and off the shelf sizes and grades and a variety of custom fabrications capabilities. ISO 9001 and ISO 13485 quality management certifications in place since 1998.

There are nearly 60 grades of stainless steel, type 304 accounts for nearly 50% of all stainless steel used followed by type 316.

• Distribution. Eagle ships products from inventory, including tubing, bar stock, hollow bar, wire. Stocking both seamless and welded tubing.

• Precision Cut-to-length. Cutting and deburring hypodermic, fractional, metric tubing, and pipe.

• Custom-fabricated components. Working to customer specifications and specializing in Bending, CNC and EDM/ ECG machining and Laser machining.

Cut-to-length tubing – Eagle’s facilities enable cutting and deburring 1 ½ “ diameter tubing in quantities from a single piece to millions of pieces. Burr free production. Removing burrs creates a smoother, more functional durable metal part.

Bending – Stainless steel can be bent in multiple directions and angles without excessive distortion, wrinkling or fracturing. Things to keep in mind when bending are the bend radius, yield strength, material thickness and if it is welded or seamless.

Eagle Stainless Tube & Fabrication, Inc.

Call us. We are ready to help with any of your metal needs!

Phone: 800.528.8650 Fax: 800.520.1954 www.eagletube.com

End forming – Ensuring repeatability for proper mating of flare and end-reduced tubes. Closedend tubes are spun closed and welded shut in various end configurations including round, flat or pointe. Advantages to end forming tubes is an enhanced tube strength, connectivity improvements and increased sealing capabilities.

CNC Machining – can result in improved accuracy, increased production speeds, enhanced safety, increased efficiency, and cost savings

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Thoughts of tubing may offer circular images. Tubing comes in many shapes, sizes and thicknesses. Round, oval, rectangular or square, stainless steel tubing is versatile and popular. Formed components are ideal for uses in surgical devices, heat exchangers, instrumentation and handling equipment.

ElectroCraft, Inc. is a global provider of dependable, application-engineered fractional-horsepower motor and motion products. The ElectroCraft Powering Innovation custom manufacturing services cover the following products: AC motors, PMDC motors, brushless DC motors, stepper motors, servo motors, gearboxes, gearmotors, linear actuators, drives, servo drives and integrated motor drives.

Our products are found in thousands of different applications within industrial, commercial and consumer product markets. While ElectroCraft provides a wide array of standard products with many configurable options, we have built our brand on custom OEM solutions that meet the precise performance, cost and quality our customers require.

For OEM Customers who are unsatisfied with having to design around inflexible off-theshelf products, our technical knowledge and cusomizable product families provide for a design experience which results in motor and motion systems that provide superior reliability and performance at the lowest possible cost.

ElectroCraft AxialPower™ Enhanced Series

ElectroCraft has expanded it’s stepper linear actuator lineup to include the highperformance 28mm, 42mm and 56mm (NEMA 11, 17, 23) frame size.

ElectroCraft, Inc. 844.338.8114 www.electrocraft.com

These new linear actuators are highly configurable and available with a variety of imperial or metric leadscrew options. The Enhanced-Series offers 50% more force than competitive sized designs.

APES11M: NEMA 11 Stepper Linear Actuator Technology: Stepper Size: NEMA 11

Force: 71 N (16 lbs.) to 190 N (43 lbs.)

APES17: NEMA 17 Stepper Linear Actuator Technology: Stepper Size: NEMA 17 Force: 107 N (24 lbs.) to 1001 N (225 lbs.)

APES23: NEMA 23 Stepper Linear Actuator Technology: Stepper Size: NEMA 23 Force: 267 N (60 lbs.) to 1779 N (400 lbs.)

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ElectroCraft hybrid stepper linear actuator solutions provide original equipment manufacturers the precision, performance and reliability that is required for a wide variety of motion control positioning applications. From medical and laboratory equipment to industrial machinery, ElectroCraft offers configurable or completely customizable solutions in three unique product designs: linear actuator (non-captive), leadscrew motor (external linear) or guided linear actuator (captive).

www.medicaldesignandoutsourcing.com

As the exclusive provider of FAULHABER products for North America, FAULHABER MICROMO creates value through advanced design and engineering services.

We’re proud to offer the broadest range of high precision, high performance products for micro motion applications in the medical market.

FAULHABER MICROMO brings together the highest quality motion technologies and value-added services in North America plus global engineering, sourcing, and manufacturing to deliver the best micro motion solutions. FAULHABER partners with customers to deliver quality, innovative solutions faster and better every time.

FAULHABER MICROMO is your full service, value added outsourcing partner:

• ISO 9001 and 13485 certification

• Custom design and complete clean room subassembly

• Express prototyping

• Machining center

• State-of-the-art testing laboratory

• Energy-efficient solutions and enhanced product life

FAULHABER’s benchmark motion solutions are part of numerous medical devices and applications, such as medical pumps, surgical robotics & end effectors, laboratory automation, point-of-care diagnostic systems, haptics systems, medical imaging, bionic prosthetics and more.

EXCELLENCE IN MICRO MOTION SOLUTIONS

Since 1961, FAULHABER MICROMO is the trusted partner of OEMs for micro motion solutions and subassemblies. As the industry leader with micro motor, encoder technology as well as design customization, we bring together value-added services and cutting-edge technologies from around the world through high efficiency, high performance rotary and linear offerings, such as brushed, brushless, stepper, flat DC motors, piezoelectric & linear motors.

YOUR SOLUTION, OPTIMIZED

FAULHABER MICROMO creates value through advanced design and engineering services:

• Precision Actuation Systems

• Design and Integration Components

• Drive and Control Integration

• Performance and Cost Optimization

QUALITY LEADERSHIP

FAULHABER MICROMO is ISO 9001 and ISO 13485 certified as well as RoHS compliant. With the FAULHABER Group’s ISO 14001 certification, FAULHABER MICROMO provides the highest quality standards for the design, development and manufacturing of fractional horsepower drive systems for diverse markets.

FAULHABER MICROMO

14881 Evergreen Ave. Clearwater, FL 33762

T: (800) 807-9166 www.faulhaber.com

TECHNOLOGY LEADERSHIP - IT ALL STARTED DECADES AGO WITH THE “FAULHABER COIL.” Decades ago, Dr. Faulhaber patented the first selfsupporting, ironless, skew-wound rotor coil, and the FAULHABER Drive Systems product portfolio evolved from this innovative motor technology, based on utilizing hollow, coreless, low-inertia rotor coils for maximum power and efficiency in the absolute smallest physical spaces. FAULHABER is the premier provider of micro motion control systems. FAULHABER’s product line includes fractional horsepower DC coreless motors, brushless DC motors, stepper motors, piezo motors, linear servo motors, precision gearboxes, high resolution encoders, fail-safe brakes, speed and motion controllers, micromechanical systems, and custom subassemblies that incorporate these products for integration into OEM devices.

IT’S ALL HERE IN NORTH AMERICA

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From concept to delivery, FAULHABER MICROMO (Clearwater, FL) provides it all. With on-site machining and assembly facilities, a versatile standard product line, an Advanced Engineering Group, and over 5,000 special executions, customization is our strength. FAULHABER MICROMO’s operations include a state-of-the-art CNC machining center, a 12,000 ft² clean room assembly operation (class 100,000 capable), and a design, R & D and engineering testing center. All application work is carried out by in-house engineering staff. FAULHABER MICROMO’s engineering team partners with customers for the design, specification and after sales support of industry leading motion control products. Advanced online tools, such as the FDST (FAULHABER Drive Selection Tool) used for evaluating and selecting a variety of product configurations and performance options, combined with our easy online store, OEM engineers can easily and quickly purchase compact motion systems day or night. Plus, with our localized inventory, many products can be delivered in three days or less to meet immediate design and testing requirements.

Contact FAULHABER, and let’s get your application in motion, today!

Filmecc USA, Inc. [Asahi Intecc Group]

High Performance Components

Filmecc USA, Inc. [Asahi Intecc Group] is a ISO9001/13485 certified manufacturer of precision medical components, extruded tubing, PTFE Liners, sub-assemblies, and guidewires. We supply our products to over 100 countries around the world. We have five R&D facilities located in Japan and the USA as will as production facilities in Japan, Thailand, Vietnam, and the Philippines. Our ACTONE flexible cable tube (1 to 1 torque response), motor driven drive cables, and multi-layered torque coils, miniature coils, braid-reinforced catheter tubing are all high quality and high performing products that can be used in you delivery system, catheter, or device. High-Volume manufacturing capabilities are available. Device assemblies and subassemblies are offered.

Asahi Intecc Group is an industry leader due to our Torque Processing which is one of our four core technologies along with Wire drawing, Forming, and Coating Technology. Asahi is industry leader in 1 to 1 torque performance of our components and guidewires. Our experience in many medical applications makes Asahi Intecc unique as we can offer many components along with value-add options like subassembly, coatings, laser welding, PTFE Liners, and much more. We also offer OEM/ODM service. Our products are used in many medical applications such as cardiovascular catheters, microcatheters, sheaths, guidewires, delivery systems, retrieval systems, imaging devices, surgical tools, and orthopedic devices. Our components are intended for use in applications requiring torque response, flexibility, kink resistance, and maneuverability within a small profile or tortuous path.

Filmecc USA, Inc. [Asahi Intecc Group] 3002 Dow Avenue, Suite 216 Tustin, CA 92780

https://filmecc-us.com

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Flimecc USA, Inc. is part of the Asahi Intecc Group, a Global Medical Company based in Japan with over 10,000 employees worldwide. We are trusted partner to world leading medical device companies that have our products used in Cardiovascular, Peripheral Vascular, Structural Heart, Neurovascular, Endoscopy, Urology, ENT, and other markets. We are a CDMO that provides a wide range of capabilities for design and manufacturing of components, catheters, delivery systems, and guidewires. We are an industry leader in precision wire-based components like our ACTONE Cable Tube, OEM guidewire design and manufacturing, extruded tubing, PTFE Liners, torque technologies, and coating technology. We offer contract manufacturing and provide design & development services.

Design Develop and Deliver

Flexan is a global strategic contract manufacturer of custom highquality silicone and thermoplastic components, sub-assemblies and devices designed to meet the critical requirements of our customer’s medical devices

Flexan 500 Bond Street Lincolnshire, IL 60069 www.Flexan.com (224) 543-0003

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Our experience goes back more than 75 years, which allows us to provide our clients with a greater perspective, a better process and improved overall medical device manufacturing experience.

With locations across the globe, Flexan has the pedigree a medical device company is looking for when they seek a custom contract manufacturer.

Freudenberg Medical is a global CMO / CDMO with 11 manufacturing operations and more than 2,400 associates worldwide. Manufacturing capabilities range from high precision molded components and medical tubing to drug coatings, finished devices, catheter shafts and hypotubes for minimally invasive, handheld, and catheter-based devices.

ISO 13485 certified quality systems and FDA registered sites are located throughout the Americas, Europe, and Asia.

Freudenberg Medical has the experience and expertise to simplify your supply chain and get product to market faster. A global network of R&D and manufacturing facilities supports customers from material selection and design optimization to prototyping and mass production of components and finished devices.

Freudenberg Medical has introduced a number of pioneering process and product innovations over the past year. These include:

A groundbreaking extrusion technology, Helix iMC™ continuously measures the inner geometry of silicone tubes. Unique to the industry, it increases product quality for critical tubing applications and dramatically reduces material waste and process time.

HelixTwist™ multi-lumen tubing is designed to provide an equal balance of stress across the inner and outer lumens as the tube bends. Ideal for pacemakers, breathing tubes, and other applications which require navigation through tortuous pathways within the body.

Freudenberg Medical

California • Indiana • Massachusetts Minnesota • Costa Rica • Germany Ireland • China info@freudenbergmedical.com www.freudenbergmedical.com

As a materials specialist, Freudenberg Medical has developed a proprietary conductive silicone compound used for smart therapeutic devices that deliver electrical currents also to shield sensitive electronics.

Freudenberg Medical holds patents for minimally invasive technologies, these include the Composer® Catheter Handle Platform, hemostasis valves with variable diameter seals, and expandable introducer sheaths. Three next generation Product Solutions were just added to the portfolio – Composer® EPIC and Composer® Toccata Catheter Handle Platforms, and the HyperSeal® Mini hemostasis valve. Designed for medical device companies looking to accelerate time to market with commercialization-ready solutions.

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And announcing the latest in needle devices from Cambus Medical, Velona Custom & Specialty Needles for fine needle aspiration, fine needle biopsy, minimally invasive delivery systems, and structural heart applications.

Galt Medical OEM has been a leading provider of vascular and interventional medical devices for over 30 years, developing and manufacturing a range of products for interventional procedures. We offer products private labeled and bulk nonsterile to medical device OEMs. Our regulatory, customer service, engineering, and marketing teams are located in our Garland, Texas headquarters, with manufacturing done both at our Garland location and in Costa Rica. Clinicians in six continents use Galt products for a range of Interventional Radiology, Interventional Cardiology, Vascular Surgery, and IV Therapy procedures.

Galt products are widely recognized for their quality by our OEM customers and clinicians.

Galt Medical OEM 2220 Merritt Dr Garland, Texas 75041 https://galtmedical.com/

Galt Medical OEM products are developed through deep engagement with many clinicians and/or customer engineering teams. While many of our products serve broad markets and utilize our high-volume manufacturing capabilities, we are proud that several of our products address underserved, niche applications. We provide custom products and associated design services to a range of large and small medical device companies.

Projects range from exclusive, minor modifications of existing Galt products for an OEM partner, to unique products based on an OEM’s requirements or specifications. Our manufacturing capabilities include, but are not limited to tipping, forming, shaping, injection molding, hot stamping, hole punching, markings, assembly, packaging, tooling, and rapid prototyping/3D

printing. We also provide regulatory support to many of our contract manufacturing customers.

Galt Medical OEM is committed to providing on-time delivery, quality products, vast regulatory experience, R&D Solutions from concept to design manufacturability as well as EU MDR navigation. Our highly specialized and focused workforce is dedicated to producing quality products such as Micro Introducer Kits, Specialty Guidewires, Tearaway and Valved Introducers, Drainage Catheters as well as Accessories including Dilators, Needles, Torque Devices, Valve Adapters, Stylets. Galt Medical OEM is Trusted Experience and Industry Leader.

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Halkey-Roberts is a leading supplier of plastic components and subassemblies used for fluid and gas management in disposable medical devices. We supply all of the major OEM medical device and Life Science companies worldwide. We are ISO 13485 certified and manufacture to GMP standards.

Our standard and customized medical valves include those used as substitutes for needle ports in IV and drug delivery applications, catheter balloon inflation valves, tubing clamps, tubing flanges, fill and drain closures, hand pumps and pressure relief valves.

Our comprehensive line of high flow, split septum swabable valves feature a unique and innovative patented design that allow the valves to be used in a wide variety of demanding applications where high flow and a closed system are a must.

Halkey Roberts Corporation

2700 Halkey Roberts Place North St. Petersburg, Florida 33716

www.halkeyroberts.com

We have the technical and financial resources to invest in new product development and the automation it takes to produce high-quality products at the lowest possible price point. We understand the value of providing an economical solution that solves a problem and addresses a need in the market.

Our design and manufacturing groups work hand-in-hand utilizing concurrent engineering methodologies to minimize the product development cycle. Our vertical integration, meaning we mold and assemble most everything in the same facility, demonstrates our expertise in the vast array of engineering disciplines from mold building, automation, machine vision and materials.

We also understand the concept of mass customization. We combine your idea with our in-depth product knowledge and expertise in flexible automation to provide a custom product at a low unit production cost. This helps our customers differentiate their end products and provide their clients with truly custom solutions.

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Halkey-Roberts has supplied high quality products for over 75 years. We pioneered the use of plastics in the medical device industry when we introduced the Roberts’ tubing clamp decades ago. We continue to provide innovative solutions to the Medical Device and Life Science markets worldwide.

Precision Metal Components for Medical Devices

Hobson & Motzer’s world-class facilities offer the most advanced technology in metal transformation and assembly. With more than 100 years of precision manufacturing experience, we have the capabilities and infrastructure to deliver on critical projects. Our commitment to lean and continuous improvement results in superior quality, as well as exceptional supply chain performance and customer satisfaction. Our extensive tool design and engineering expertise drives repeatability and efficient production. We offer precision rapid prototyping and projectbased support, from concept to completion. Medical device components include endomechanical, electro-surgical, pharmaceutical, ophthalmic blade blanks, custom electrical contacts, and more.

Hobson & Motzer

30 Airline Road

Durham, CT 06422 1-860-349-1756 www.hobsonmotzer.com

Performance When It Counts

As a trusted supplier to OEMs, we drive the latest thinking in manufacturing through innovation and technology. We are often relied upon to make the impossible possible—or pick up where others have failed.

Our company is vertically integrated with key competencies in metal stamping, and 3-, 4-, and 5-axis high-speed CNC machining, PECM, laser cutting, welding, and assembly services. We also perform a wide range of secondary operations, all in house: pad printing, PTFE coating, metal finishing, electro polishing, and more. We have an extensive team of toolmakers and a highly equipped tool room—all supported by industry-leading design engineers and skilled project managers. Our plants are highly automated, featuring robotic automation technology that is engineered, designed, built, and supported in house.

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Vertical integration is a solid strategy—but listening to the needs of our customers has truly been the driving force behind our manufacturing depth. We invest in the right equipment, resources, and people to successfully develop in-house expertise. This ensures the highest quality end-to-end, so medical device OEMs can have confidence in our precision, our consistent quality, and a robust supply chain.

Reinvent the way you design and produce medical devices and equipment

With HP 3D Printing Solutions, you can optimize your end-to-end production workflow and unlock new design potential. Gain freedom to develop innovative, differentiated medical devices by removing design constraints and deliver accurate, high-end medical devices, all while significantly reducing operating and production costs with a simple, integrated technology that enables everything from rapid prototyping to final part production.

Healthcare companies are increasingly discovering the benefits of additive manufacturing and embracing the design freedom to produce cost-effective medical devices and equipment that they can deliver to the market quickly.

With HP’s Multi Jet Fusion 3D Printing technology, you can harness the power to quickly react to market changes and customer feedback, while streamlining tasks throughout the medical device production lifecycle. Easily and rapidly iterate, adjust your parts to meet the ever-changing requirement of product lines and increase production flexibility by producing multiple new part designs in parallel and on-demand. Keep schedules on time—own the full control over your supply chain while remaining competitive.

Manufacture possibilities with HP 3D Printing solutions. Together we can make any idea, large or small, simple or complex, a reality.

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Driven by innovation and expertise. Proven by manufacturing excellence and quality.

Integer® is a world leader in advanced medical device outsourcing, bringing unparalleled expertise and comprehensive solutions in innovation and manufacturing to customers. We have a rich, 80-year history of innovation that serves our customers with an unmatched breadth and depth of capabilities. We leverage our global presence, vertical integration, and extensive design and manufacturing know-how to partner in the development of quality components to complete systems.

Integer 5830 Granite Parkway Ste 1150 Plano, TX 75024 www.integer.net

Integer’s global workforce brings a depth of knowledge to every step of the product development process. We are a trusted partner to many of the world’s leading medical device companies who depend on our highly skilled team of engineers, machinists, toolmakers, and quality and regulatory professionals, to create the right solution for your products. Our 17 manufacturing sites operate under multiple ISO certified systems and are committed to ensuring the products we produce meet or exceed the highest standards set by the FDA, the European Community and other internationally recognized agencies. Additionally, with full control of the product’s supply chain and dual-site manufacturing capabilities, our partners receive unparalleled service.

From concept to completion, our stable supply chain, world-class manufacturing facilities and delivery performance are focused on providing customers the high-quality devices they rely on. A full-service technology partner, Integer is uniquely equipped to support critical steps across the product lifecycle. We aspire to be our customers’ partner of choice.

Our broad capabilities and expertise include:

• Research

• Design & Development

• Testing & Certification Expertise

• Rapid Prototyping

• Quality & Regulatory Expertise

• Commercialization

• Global Medical Device Manufacturing

• Vertical Integration

• Strategic Sourcing

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• Supply Chain Management

Visit integer.net to learn more.

Interpower® is a premier manufacturer of American-made electrical power systems worldwide, including North American 5-15, 5-20, 6-15, and 6-20 hospital-grade cords, and international hospital-grade cords providing correct amperages and voltages for vital medical equipment such as portable CT Scanners and X-ray machines, medical-grade treadmills, ECMO machines, and ventilators.

When designing and manufacturing hospitalgrade products worldwide, it’s essential to know the medical requirements of the country of export—select hospitals in Australia, Canada, Denmark, Japan, and the United States have proprietary requirements. (Note: any country currently without hospital-grade standards may add them to their existing electrical standards.)

Efficient Electrical Designs. Interpower manufactures medical and nonmedical cords, cord sets and components along with North American and international cable. By designing approved country-specific plugs on one end of the cord, and adding an IEC connector on the other, customers reduce cost by not warehousing country-specific cord sets.

IEC 60320 components create a common connector interface. Our C13 and C19 IEC connectors and other IEC connectors, inlets, outlets, and plug connectors require only one country-specific plug for the mains power at the wall socket. The opposite end of the plug terminates in an IEC 60320 connector which plugs into the inlet of the Accessory Power Strip (APS) or Power Distribution Unit (PDU). Now IEC jumper cords connect to equipment or devices by plugging into the multiple outlets along the APS/PDU.

® ®

Interpower® Group of Companies

P.O. Box 115, Oskaloosa, IA 52577-0115 (800) 662-2290 sales@interpower.com www.interpower.com

Testing. All Interpower cords, cord sets and components are U.S.A.-made and tested according to Interpower’s quality plan: hipot testing, continuity testing, and ground testing with multiple inspections. However, hospital-grade cords approved by UL and CSA in North America must pass rigorous testing per UL 817 (18.2.4.1) and C22.2 No. 21-14 for hospital-grade power cord sets.

Interpower offers no minimum order or dollar requirements, and same day shipping on in-stock Interpower products.

Please visit our website at www.interpower.com. Email us at sales@interpower. com or contact Customer Service at (800) 662-2290.

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Founded in 1990, Isometric’s success begins and ends with our people. Isometric is ISO 13485 certified with two adjacent facilities, three Class 7 cleanrooms, and over 120 employees.

With unparalleled micro manufacturing capabilities, Isometric provides 100% in-house processes:

• Micro 3D Printing

• Micro Tooling

• Micro Molding

• Micro Automated Assembly

• CT Scanning

A global micro solutions leader, Isometric serves high precision medical market segments including diabetes, ENT, ophthalmic, cardiovascular, neurovascular, orthopedic, and drug delivery. Isometric’s micro solutions include microfluidics, microneedles, catheter tips, sensors, transdermal patches, life science disposables, and neurovascular implant devices. Driven by ambition for innovation, Isometric’s team of experts use our internally developed Microns Matter® risk mitigation process to successfully meet tolerances and bring your micro parts to validation faster.

From Small to Micro, Success Starts Here.

For over 30 years, Isometric Micro Molding, Inc., has been a strategic and trusted partner in micro injection molding and micro automated assemblies with unparalleled micro manufacturing capabilities. Today, we are the fastest growing medical-focused micro molder in North America.

Since we work in microns every day, we serve high precision medical markets including diabetes, ENT, ophthalmic, cardiovascular, neurovascular, orthopedic, and drug delivery.

At Isometric, our team of experts make the impossible, possible, through 100% in-house processes: Micro 3D Printing, Micro Tooling, Micro Molding, Micro Automated Assembly and CT Scanning. In addition, we mold all thermoplastics, long-term implantable, bioresorbable, fluoropolymers, silicone, and API resins. From small parts with micro features to micro-sized parts, we provide unique, creative, and robust miniaturization solutions. We successfully create components through extreme thin wall molding, tight tolerances, complex geometries, insert molding, overmolding, and 2-shot molding. Your micro solution is completed all inhouse and under our control.

We are committed to strategic partnerships through transparent and honest customer collaboration. Coupled with our Microns Matter® proven risk mitigation process, we account for all variables that contribute to the successful validation of your project. Our ambition for innovation means your project can achieve success faster.

Isometric Micro Molding, Inc. 240 Wisconsin Drive New Richmond, WI 54017 sales@isomicro.com www.isomicro.com

When you partner with Isometric, you can unleash your FULL design potential, usually thought impossible, to achieve incredible micro solutions.

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Isometric Micro Molding’s small part molding (3 inch or 76.2 mm with 175 micro features of 30 microns or 0.00118 inch); human hair as a size reference

HELPING ENGINEERS SUCCEED

JW Winco, Inc., A Ganter Company, is a leading supplier of Standard Industrial Machine Components and Assembly Hardware that also specializes in offering value-added services to engineers. Standard parts are extremely versatile in their application and therefore can offer great opportunities. An increased use of standard parts greatly reduces the costs of product development and in turn, provides the engineer with more time to devote on larger project requirements. The engineers can concentrate on the actual machine or equipment design, as standard parts can costeffectively be procured externally. The wheel does not have to be reinvented, and the creativity in developing can be the focus again.

JW Winco offers catalogs or digital part libraries that users can access quickly. Along with an extensive selection of high-quality parts, JW Winco strives to make an engineer’s job easier. The company’s mobile-responsive website at www.jwwinco.com is dedicated to providing the customer with modern navigation and usability that also allows visitors to see product availability. Features include filtering capabilities to find products faster and easier, the ability to build and price parts to easily create the standard part required for the design, and free CAD download in all common 2D and 3D CAD formats. Customers can not only check product availability and pricing online, they can set up an account or make a purchase easily 24/7 with a credit card. JW Winco prides itself on its knowledgeable technical sales associates who provide assistance with products and applications. Customer service is a top priority. To provide customers with complete solutions, JW Winco also offers secondary machining, special kit packaging, and bar coding.

For more information, visit www.jwwinco.com, call 800-877-8351, fax 800-472-0670, or email sales@jwwinco.com.

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Sanline

Handles and operating parts can act as vectors for many pathogens. The antibacterial standard parts of the Sanline product family by JW Winco can prevent bacteria and germs from propagating on an operating part, actively reducing their spread and preventing bacterial illnesses.

https://www.jwwinco.com/en-us/antibacterial-parts-sanline

Stainless Steel Latches GN 1150 in Hygienic Design

Stainless steel latches GN 1150 are intended for use in hygienic areas and meet hygienic requirements on the operating side (front hygiene) or on the operating and latch arm side (full hygiene).

The locking mechanism is protected by multiple seals. At the same time, the high surface quality (Ra < 0.8 µm) and dead space-free mounting prevent dirt from adhering and facilitate cleaning.

https://www.jwwinco.com/en-us/products/quick-finder?q=1150

GN 1582 Stainless Steel Screws in Hygienic Design

Captive stainless steel screws GN 1582 with recessed shoulder for loss protection expand the product family Hygienic Design. The sealed mounting surface enables components to be mounted without dead spaces.

Due to the recessed shoulder, they are easily secured against loss, such as in a cover.

https://www.jwwinco.com/en-us/products/3.2-Mountingpositioning-levelling-with-screws-clamping-and-supportingelements/Swing-bolts-Shoulder-screws-Thrust-bolts/ GN-1582-Stainless-Steel-Hexagon-Head-Screws-HygienicDesign-Low-Profile-Head-with-Recessed-Stud-for-LossProtection

800-877-8351 fax 800-472-0670 sales@jwwinco.com jwwinco.com

Johnson

Matthey Medical Device

Components provides high-quality micromachined components, implantgrade Nitinol parts, and advanced coating solutions. Our vast knowledge in PGM metals (including platinum, palladium, iridium), microfabrication processing, and metal management services accelerates med-device time-to-market. Whether it’s gold or platinum marker bands, to PGM wire, sheet, or custom components, JM-MDC delivers unparalleled quality and precision. Our world-class nitinol sheet and tubing line offers expanded capacity in a LCC manufacturing region. JM-MDC is committed to manufacturing excellence and metals sustainability, providing customers with continuity of supply for critical precious metal components.

Johnson Matthey Medical Device Components is a global leader in precious metals management and microfabrication.

For 200+ years, JM-MDC developed specialized techniques for the processing of PGM metals and is one of only a few companies globally with the infrastructure to support intensive processing of PGMs like melting, extruding, recycling, and refining. Deploying an array of micromachining techniques including swiss screw, electrical discharge machining, or femtosecond laser micromachining, JM-MDC continually pushes the boundaries to deliver exceptional quality at unimaginable tolerances, proudly supplying over 100+ million medical components into 30+ million medical devices.

Johnson Matthey - Medical Device Components

12205 World Trade Dr San Diego, CA 92128 https://matthey.com/medical

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The JM-MDC’s leadership extends into intimate collaborations with the medical device community. Providing PGM expertise for decades and pioneering medical nitinol sheet, JM-MDC’s technical team routinely offers DFM guidance including advanced support of new alloy combinations and innovative platinum manufacturing using nano-particle inkjet printing. Industry partnerships have also spawned further investments in the form of facility expansions, cutting-edge manufacturing equipment upgrades, and new facilities like the JM-MDC Nitinol Center of Excellence located in the low-cost manufacturing region of Mexicali, Mexico. Continuity in metals supply coupled with microfabrication innovation positions JM-MDC as a premier leader in specialty metals medical components today and for decades to come.

If you’re looking for an automation partner who understands the precision and care required to manufacture the world’s finest drug delivery devices, consider Kahle Automation, Engineering Excellence since 1920 and now a part of the BBS Automation family.

Federico Ceresetti, CEO Kahle Automation: “Partnering with BBS Automation was the logical next step in Kahle’s development.” With access to BBS’ global reach and market leading reputation, BBS will support Kahle on larger projects and continue its successful growth trajectory by leveraging manufacturing and service capabilities on three continents.

Successful automation requires an automation partner who truly understands the process of manufacturing medical devices. Regardless of whether you’re looking for a system that assembles thousands of devices per minute, improves the quality and consistency of your manufacturing process or whether you’re simply trying to maximize the space in your clean room, Kahle has the technical solutions to meet your goals.

89 Headquarter Plaza North 3rd Floor Morristown, NJ 07960 www.KahleAutomation.com

Every year, Kahle dedicates over 182,500 man-hours to designing automation systems that manufacture medical devices. This effort has resulted in the largest portfolio of proprietary automation technology in the entire industry. From this portfolio, you can choose from continuous, indexing and asynchronous motion assembly platforms that feature the latest innovations in mechanical, pneumatic and robotic assembly with premium inspection and process control operations. This flexibility allows us to create cost efficient, effective systems for projects of every size. Beyond creating the ideal assembly system for your project, your Kahle team is also focused on getting your machine validated promptly and transitioned efficiently into production. Further, we want to make it easy for your employees to be trained to operate and maintain the equipment. In addition your Kahle machine arrives with the best quality and validation documentation in the industry.

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Kahle Automation

Quality Interconnect Components and Electronic Hardware

Leading–edge technology and precision manufacturing have defined Keystone’s performance as a world-class manufacturer of precision, electronic interconnect components and hardware since 1950.

Keystone Manufactures precision stampings and specializes in progressive dies, four slides, wire forming, in-die tapping, and high-speed blanking. Assembly procedures include eyeleting, riveting, staking, swaging, inserting, crimping and screw insertion to assemble components into finished products.

Our Product Design Guide M70 features products for OEM Designers and Engineers who create/develop state-of-the-art electronic products/instruments/systems. Our Custom Manufacturing Division provides modifications and custom fabrications and is fully integrated with in-house, precision tool and die shop that utilizes the latest CAD/CAM and 3D modeling software to provide close tolerance Stamping, Machining and Assembly services.

Keystone is ISO 9001:2015 certified and RoHS/ REACH compliant with USA headquarters and offices in Canada, Europe, Australia and Asia. Visit our website for our Dynamic Catalog of Products or to request our Product Design Guide M70

Battery Clips, Contacts, Holders & Retainers

Advances in portable electronics and LithiumIon battery technology demand dependable battery connections. Keystone leads the way with a vast range of reliable, high-quality, costeffective products for most battery types.

Test Points & Terminals

Low profile and limited board space drive today’s PCB connectivity designs. Keystone is the right fit with UL Recognized Quick-fit Male and Female PCB terminals, Snap-on, Snap-Fit and PCB Screw Terminals as well as SMT and THM Test points and Jumpers and more.

55 South Denton Avenue New Hyde Park, NY 11040

800.221.5510 or 516.328.7500

Email: kec@keyelco.com www.keyelco.com

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Pins, Plugs, Jacks & Sockets

Keystone’s USB 2.0, 3.0 & 3.1 Jacks & Plugs, Micro Pins/Jacks, Banana and Phono Plugs & Jacks are designed for use in the latest Mobile & Computer Electronics, Home Theatre, Test Gear and Industrial Interconnects.

Fuse Clips & Holders

Fuse connectivity products for Electronics, Datacom, Telecom, Automotive and Solar use.

Keystone offers Surface Mount, Thru-Hole and Rivet Mount products for Cylindrical, Automotive and Subminiature fuses.

Spacers, Standoffs/Supports

Diverse insulated and non-insulated spacers and standoffs are available in a wide range of lengths, thread sizes, hole sizes, mounting styles & materials. Choose from English or Metric type products for your PCB, panel and mounting applications.

Multipurpose and Panel Hardware

Check out the diverse selection of Panel and Mounting hardware Keystone is well known for. Fan Filters & Guards, LED Lens Caps, Holders & Spacer Mounts, Jack Screws and Connector Hardware, Instrumentation Handles, Cable Clamps, Knobs and more.

KNF Neuberger is an independent familyowned company comprised of 24 global locations dedicated to providing tailor-made solutions with diaphragm, solenoid, swing piston and boxer pump technologies.

We have solved thousands of design challenges for a variety of application tasks, including: fluid supply, liquid waste handling, washing, recirculation, and metering/dosing; aspiration, degassing/ debubbling, chamber evacuation, and vacuum roughing/backing; gas transfer and pneumatics.

KNF’s broad applications and systems experience stretches across a diverse set of industries, including medical device and diagnostics, environmental/ industrial hygiene, laboratory equipment, reprographics, security and defense, semiconductor, energy, various process industries, and more.

KNF is a technology leader with over 300 patents and a solid reputation for providing innovative, high performance, reliable pumps. Drawing on our expertise in various fields of engineering, from mechanics, materials, and fluidics to electronics and software, KNF strives to find the smartest solutions for every application – not just for today but innovated over time to continuously serve evolving needs.

One size doesn’t fit all. We collaborate closely with our customers throughout the entire development process – from the initial idea to the final result – to create the best solution for each specific application while balancing required performance, product lifetime, and cost.

By understanding customers’ applications and specifications, KNF engineers strive to optimize not only our pump, but to also assist customers in optimizing their overall system. Our job is to fit the pump to your application – not the application to a pump. In fact, customers often send us problematic systems for testing. Whether the issue is related to the pump or other system components, we’ll provide a full report with analysis and recommendations.

Whatever the challenge, KNF is ready to bring a deep bench of engineering, fluidics, and applications expertise to your next project.

KNF Neuberger

Phone: 609-890-8600 Email: knfusa@knf.com Web: www.knf.com

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Laird Connectivity simplifies wireless connectivity with market-leading RF modules, internal antennas, IoT devices, and custom wireless solutions. Our products are trusted by companies around the world for their wireless performance and reliability. With best-inclass support and comprehensive product development services, we reduce your risk and improve your time-to-market. When you need unmatched wireless performance to connect your applications with security and confidence, Laird Connectivity delivers – no matter what.

Laird

Connectivity

Laird Connectivity is the partner of choice for medical device manufacturers. Our wide range of solutions and services enable you to rapidly deploy products that meet the most stringent security standards and work in even the most difficult RF environments. Our products are expansive in their applications, providing secure connectivity to medical equipment for patient monitoring, surgical, infusion, portable, bedside, and more.

We are here to help our customers every step of the way so they can reduce time to market. From selecting and integrating a wireless solution to trouble shooting in the field with end customers, we have dedicated engineering teams standing by and ready to assist. We also know the importance of longevity. Long Term Support considerations are built into our solution design. Through our customers’ initial development phase, certification, and approvals phase, commercial launch and full market life-cycle, we support strategies that keep our customers’ devices viable. We prioritize flexibility in packaging along with backward and forward compatibility.

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Founded in 1918, Lee Spring is headquartered in New York, with multiple locations in the United States, Mexico, Europe, India and China. The Lee Spring brand sets the standard for excellence through bold product innovations, quality manufacturing and responsive customer care. Lee Spring takes pride in creating solutiondriven responses. The Lee Spring Sales Team, Engineering Team and Manufacturing Team collaborate to develop application specific resolutions.

Lee Spring understands the value of our customers for well qualified engineering support. Lee Spring engineers can offer assistance from design conception through project completion. Extensive expertise in spring design and mechanical engineering complement our customers’ design teams. Lee Spring’s expanding global presence and in-depth knowledge of the worldwide marketplace puts Lee Spring at the leading edge of creating market specific solutions for customers’ needs.

Lee Spring manufactures and distributes mechanical springs, wire forms, stampings and fourslide parts worldwide. Our extensive print and online catalog offers over 25,000 inventoried products in a variety of materials. From 10 springs to 10 million springs, Lee Spring is a premier global source for stock catalog and custom designed mechanical springs and related products.

Lee Spring continues to respond to the voice of the customer with advanced Custom capabilities and unique Stock products such as LeeP™ Plastic Springs, Bantam™ Mini Springs, Lite™ Pressure Springs and our latest expansion of Stainless Steel 316 springs. All stock products are available through our website or our print catalog.

• We make it easy - exceptional personal attention

• We have it - over 25,000 catalog products

• We can design it - engineering expertise

• We can make it - extensive custom manufacturing capabilities

www.leespring.com

STOCK SPRINGS

Over 25,000 Stock Springs

Online CAD Downloads

Free Ground Shipping Options Available

• Over 25,000 Stock Imperial and Metric Designs

• Free CAD Downloads

• Live Engineering Support

• Free Ground Shipping in Continental U.S.

• Free Passivation on Stainless Steel Springs

• Free Plating on Music Wire Springs

• Free Grinding on Standard Compression Springs

• Free Certificates of Compliance

• Guaranteed RoHS & Reach Compliance

• Online or Phone Ordering

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• Inch and Metric Designs

CUSTOM SPRINGS

Wire Forms, Stampings and Springs

Prototypes to Production Runs

Turning Ideas Into Reality

• Pull/Kanban Capabilities

• CAD Assisted Product Design, Drawing & Modeling

• Live Engineering Support

• In-House Prototype Production Services

• Free Material & Chemical Certification

• Free Certificates of Compliance

• In-House Tooling Production Including EDM

• Governmental and Industrial Regulatory Expertise

• Global Supply Chain Network

• Long or Short Runs

• Proprietary Quality Control System

www.medicaldesignandoutsourcing.com

LEMO®, founded in Switzerland in 1946, took its name from the company founder, engineer Léon Mouttet. Originally a manufacturer of contacts in noble and rare metals, the company took a major step forward in 1957 with the introduction of the push-pull selflatching connector.

In 1984 LEMO purchased REDEL and LEMO then began marketing plastic connectors to the medical market. Today LEMO’s largest market in the USA is medical and continues to grow. Due to the high demand and increased sales for cable assemblies, LEMO purchased Northwire, Inc., a wire and cable manufacturer, in the Summer of 2014, to complete the solution.

LEMO USA, INC.

635 Park Court, Rohnert Park, CA 94928 USA Tel: 707-206-3700 Mail: info-us@lemo.com www.lemo.com

NORTHWIRE, INC. 110 Prospect Way Osceola, WI 54020 | USA Tel: (800) 468-1516 Mail: CableInfo_Northwire@lemo.com www.northwire.com

LEMO® is the leader in designing and manufacturing precision custom interconnect solutions. High-quality LEMO Push-Pull connectors and Northwire Custom Cables are used in a wide range of challenging applications such as Medical, Autonomous Vehicles, Robotics, Aerospace, Defense, Space, Information Systems, and Test & Measurement.

Why LEMO

• Standard/Custom Design for Applications such as Pulsed Field Ablation

• Disposables

• Touch Proof

• Steam Sterilizable

• 3 High Voltage configurations (2, 5 & 8 contacts)

• IEC 60601 compliant

• Temperature range -50°C to 170°C

• Lightweight and compact design for space savings

Northwire, Inc. celebrates 50 years as an innovator in custom wire and cable manufacturing and interconnectivity solutions for medical device/life science, robotics, industrial, off-road heavy equipment, aerospace, defense, test & measurement applications, and more.

Why NORTHWIRE

• Quality custom cable solutions for Electrophysiology, Mapping, and Ablation; Surgical Robotics (RAS); Laparoscopic Surgery; Electro Surgery; Patient Monitoring

• BioCompatic® Silicone Alternative USP Class VI medical cable

• Design engineers help you navigate complex regulatory requirements and select the right cable materials and components for your exact end application

• Quality Management System certified to ISO 9001 and ISO 13485

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• Push-Pull quick and secure locking

• Water-resistant IP66 available

Master Bond formulates cutting edge adhesives, sealants, coatings and potting/ encapsulation systems for challenging medical device applications.

High Performance Adhesives, Sealants & Coatings

Our expansive line of epoxies, silicones, UV curable and LED curable compounds can be customized to meet a myriad of property requirements including:

• High/low temperature resistance

• Electrical conductivity/insulation

• Thermal conductivity

• Sterilization resistance

• High/low viscosity

• Flexibility and toughness

• Optical clarity

Developed to withstand harsh environmental conditions, our products feature superior longterm durability. They are used in a variety of industries and are designed to meet stringent industry standards and are certified for:

• USP Class VI

• ISO 10993-5

• NASA low outgassing

• FDA CFR 175.300 & FDA CFR 175.105

• UL 94V-0 & UL 94V-1

• and more

Master Bond

154 Hobart Street Hackensack, NJ 07601 Tel: 201-343-8983 Fax: 201-343-2132 www.masterbond.com technical@masterbond.com

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Outstanding Customer Support

Master Bond makes customer support a fundamental priority in the adhesive selection process. Our technical specialists have decades of experience and will work with you, one-on-one, throughout the design, prototyping and manufacturing stages of your application.

EP62-1HTMed: Non-Cytotoxic Epoxy Resists Sterilization Master Bond EP62-1HTMed is a two part epoxy that meets the requirements of ISO 10993-5 for non-cytotoxicity and can be utilized in many medical device applications. It resists repeated sterilization cycles, including STERRAD® and autoclaving. It is also capable of withstanding exposure to gamma radiation, ethylene oxide, bleach and other aggressive sterilants and chemicals.

LED405Med: Biocompatible, Nanosilica Filled LED Curable Adhesive LED405Med is a one component, LED curing adhesive system that meets ISO 10993-5 cytotoxicity requirements for use in medical device assembly. It does not need a UV light for curing, is optically clear, and offers excellent light transmission properties.It has a nanosilica filler resulting in both lower shrinkage upon cure, as well as greater dimensional stability.

maxon drives set the world in motion.

maxon combines electric motors, gears and DC motor controls into high-precision, intelligent drive systems that can be custom-made to fit the specific needs of customer applications. maxon helps provide innovative solutions at competitive prices for numerous applications in various markets, such as industrial automation, medical, robotics and aerospace.

maxon precision motors, inc. 125 Dever Drive Taunton, MA 02780 508.677.0520 info.us@maxongroup.com www.maxongroup.us

At maxon, we focus on comprehensive solutions optimized through a diversified product range and client consultation.

maxon manufactures small, high-quality brush and brushless DC motors ranging in size from 4 mm to 90 mm. maxon’s rhombic wound ironless rotor motors provide exceptionally high efficiency, low EMI emissions, fast acceleration, no preferred rotor position, torque constants and long service life. The drive components are assembled and designed according to your individual needs. Our modular system includes planetary, spur and special gearheads as well as encoders and control electronics.

With over 50 years of experience, hightech innovations and superior product quality, maxon is the reliable partner in drive technology. Individual, customized drive solutions are our greatest strength.

Extremely powerful drives that are easily configured online. Customers can fit the drives with specific mechanical and electrical components specific to their application needs. It is possible to customize the shaft lengths, winding types, ball bearings and much more. When combined together with maxon encoders and planetary gearheads, you form a high-precision, robust drive system ideal for any application requiring a compact, powerful, quiet and strong drive system. In addition, detailed product data may be viewed immediately online and 3D CAD data for the configuration is available for downloading.

Visit xdrives.maxongroup.us

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On

Go to www.maxongroup.us

Full- Service Contract Manufacturer

We are an ISO 13485:2016 certified, FDA Registered contract manufacturer offering innovative manufacturing solutions for the medical and biotechnology industries. We specialize in precision injection molding, assembly, packaging, project management, and design support. We have numerous certified ISO Class 7 & 8 cleanrooms and white rooms for molding and assembly. We have flexible capacity to handle major projects or small custom orders. We mold most medical grade thermoplastics, including implant grade “PEEK and all of our silicone molding is done in it’s own facility.

Medbio, LLC

5346 36th St SE Grand Rapids, Michigan 49512 P: 616.245.0214

https://medbiollc.com

Medbio is a full-service contract manufacturer allowing for development and manufacturing. We take your project from design through final assembly and packaging, while meeting all quality standards, providing documentation, and aiding in the navigation of necessary regulatory approvals.

Medbio continually invests in the latest molding technologies and assembly techniques to stay ahead of the competition. Our experience, facilities, equipment, tooling, and process control capabilities allow Medbio to provide consistent quality and value to our customers.

Our numerous facilities around the country allow us to leverage more capabilities while mitigating environmental risks to protect your project. We have flexible capacity to handle everything from small custom orders, transfers, and major projects.

We take pride in our best-in-class manufacturing capabilities, customer service, program management, aggressive turnaround times, and innovative problem solving. Whether surpassing our customers’ expectations in bringing new products to market, or improving manufacturability and part quality on transfer business, Medbio excels in providing solutions for today’s contract manufacturing challenges.

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MicroLumen has been a leading manufacturer of high performance medical products since 1987. Our high performance medical tubing is used in a wide range of minimally invasive, critical OEM applications such as cardiovascular catheters, stent delivery systems, urological retrieval devices and drug delivery.

Primary materials include Polyimide, PTFE, Pebax®, Nylon, Polyurethane and various polymers specifically designed to provide exceptional mechanical, thermal and chemical properties. Our proprietary process delivers significantly tighter tolerances for our medical and surgical tubing than conventionally extruded products.

MicroLumen offers innovative solutions and aids engineers in the design of extremely specialized medical devices. Our diversified medical product line and secondary operations include; custom laser machining, etching, composite constructions, assembly, braid / coil reinforced shafts - all that solve specific tasks. Contact our engineering team for possibilities.

MicroLumen, Inc., is registered to ISO 13485:2016.

Exceptional Products & Customer Service

MicroLumen is committed to providing high performance medical and surgical tubing of unparalleled quality and function. Our dedication to technical excellence ensures that our surgical tubing products will always be at the cutting edge of what’s possible, while maintaining the highest standards of consistency and quality. Our goals are simple. To help you, our client:

• Improve patient care

• Reduce recovery times

• Reduce the overall cost of health care

We invite you to experience the best in high performance medical tubing products. Our products include polyimide tubing, braid reinforced tubing, PTFE/composite tubes, and laser machined medical tubing.

Microlumen

One Microlumen Way Oldsmar, FL 34677 T: 813-886-1200 www.microlumen.com

Capabilities

We design and produce the highest quality medical and surgical tubing available, on time and at a competitive price. Our cutting-edge processes ensure exceptional consistency and product performance, while also providing the flexibility to create new solutions that meet your specific needs.

In our state-of-the-art manufacturing plant, our tubing is manufactured with tighter tolerances than conventionally extruded plastic tubing.

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High Performance Medical Tubing

MicroLumen provides tubing with exceptional mechanical, thermal and chemical properties for use in a wide range of minimally invasive, critical OEM applications such as cardiovascular catheters, stent delivery systems, urological retrieval devices and drug delivery.

Our innovative manufacturing process allows us to deliver significantly tighter tolerances than conventionally extruded tubing. We offer Polyimide, PTFE, Nylon, Pebax®, Polyurethane, and various polymer products. Our secondary operations, including custom laser machining, etching, composite constructions, assembly, and braid/coil reinforced shafts enable us to develop customized solutions for your exact requirements.

Complete Medical Devices & Assemblies

MICRO is a full-service contract manufacturer of complete medical devices, insert/ plastic moldings and custom fabricated tube assemblies. This includes product development & design assistance—from prototyping and validation to full-scale production. Our own tube mill for raw material, combined with our laser cutting technology and automated work cells, allow us to drastically reduce tubing costs on high volume, single-use disposable instruments. Tubing capabilities include: flaring, flanging, expansions & reductions, piercing, slotting, sharpening, electropolishing and laser welding, cutting & marking. Our modern facilities are cGMP-QSR compliant and ISO-9001, ISO-13485 & ISO-14001 certified and we maintain an ISO Class 8 clean room for surgical instrument assembly. MICRO’s Costa Rica location achieved ISO 13485:2016 Certification for its Medical Device Quality Management System in October of 2022. The 32,000 sq. ft. facility located in the Zona Franca Metro Business Park features clean room assembly and light manufacturing.

MICRO

140 Belmont Drive Somerset, NJ 08873 732-302-0800 sales@micro-co.com www.micro-co.com

A Tradition of Manufacturing Excellence

MICRO is a full-service contract manufacturer that draws on over 75 years of experience in medical device assembly, precision metal stamping, insert/injection molding, machining, sharpening, and finishing—delivering the highest quality products to customers in the medical device industry. Utilizing modern manufacturing techniques and innovative engineering solutions, we manufacture and distribute our products to customers all around the world.

To achieve these ends, we offer full-service project and supply-chain management platforms consisting of cost containment/ quality-enhancement programs, inventory consignment, just-in-time delivery, and local warehousing.

Design Engineering

At its heart, MICRO is an engineering company, staffed by experienced, innovative design engineers driven to help customers achieve their goals in a timely, cost-effective manner.

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We are the world’s largest manufacturer of titanium and stainless steel ligation clips –class-critical implant devices shipped directly to inventory. We also produce a wide variety of blades, scissors, stapling and biopsy devices, as well as laparoscopic, endoscopic and arthroscopic minimally invasive surgical instruments.

Program Management

We strive to develop and manufacture the best possible products at the best possible price, while providing a supply-and-distribution chain that allows our customers to operate at optimum efficiency and ease.

Critical to our success is our ability to design, produce and maintain the dies, molds and associated tooling used to produce customer parts. From prototyping to mass production, we are eminently capable of generating engineering designs that take advantage of our team’s unique ability to translate our customers’ needs into practical, reliable solutions.

Total solution for steel strip spring application

Ming Tai Industrial Co., Ltd. is one of leading manufacturer of steel strip springs for medical device application, including Constant Force Spring, Constant Torque Spring, Power Spring and Pre-stressed Power Spring, Variable Force Torque Spring, Variable Torque Spring and SpringStrip Tube.

With ISO 9001: 2015 and RoHs certificated, Ming Tai is capable of serving customer from the technical support in develop procedure, prototype, to trial run, mass production, spring mounting and assembly. Each manufacturing procedure, including steel strip slitting, heat treatment, edge trimming, forming process is consistent production and completed in-house to ensure highest quality requirement.

Ming Tai Industrial Company expects to be your best engineering consultant for steel strip spring application with enthusiasm. Recently Ming Tai has been helping lots of customers to develop medical devices which apply steel strip spring successfully. All innovative products include pen-type drug injector, high adjustable monitor and keyboard integrated medical workstation, high adjustable trapeze for patient bed, and patient bedside table, Bowden cable for endoscope, draw wire encoder for MRT machine. Both performance of Ming Tai’s steel strip springs and manufacturing service are gain lots of praise and appreciation from customers.

Attached figure 1, it explain that variable force torque spring exerts constant force to keep injecting drug with fixed flow, to prevent patient from feeling uncomfortable. Variable force torque spring also features stretch force in the end the stroke that ensure pen type drug injector dose drug entirely.

Figures 3, you can find constant force spring features counterbalance. These can be applied to high adjustment application, such as patient bedside table.

Since there are a number of different spring design possibilities for a given application, you are welcome to contact us in the early design phase to create an optimized spring solution for your demand. Along with high quality production, prompt delivery and competitive pricing. Ming Tai is your best partner to win the market.

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80 Sextillion Configurations with MISUMI

MISUMI is the most comprehensive and user-friendly resource for factory automation, press die, and plastic mold components. Our 80 Sextillion part configurations fit a wide scope for many of today’s advanced manufacturing technologies in such industries as automotive assembly, aerospace, medical manufacturing, 3D printing, semiconductor production, and warehouse automation.

MISUMI offers a vast selection of standard and customized parts, which make us an unmatched, one-stop-shop to meet customer specifications. Our products make us an ideal resource for many of today’s engineering teams and we are committed to empowering customers to do incredible design-work, incredibly fast, at the lowest possible cost.

MISUMI is a leader in the medical industry by manufacturing con components. Configurability allows the engineer to select the material, surface treatment, and dimensions of the component they need, with some dimensions up to 1 micron on our website. A unique and globally accepted part number is generated along with a CAD model for easy importing into their assembly. This model creates over 80 Sextillion configurations! Configurable components provide easy, fast, and flexible solutions for every phase of the medical design process from concept to build.

Not only is MISUMI a manufacturer but also a distributor and continues to expand its product offering by onboarding a variety of brands. MISUMI offers a wide range of components to medical markets including lab automation, surgical robotics, capital equipment, and contract design & manufacturing. Whether it’s actuators for a robotic system, bushings for lab automation instruments, or aluminum extrusions for automation machines, MISUMI has it covered. MISUMI is a one-stop-shop for all medical design needs.

MISUMI 1475 E Woodfield Rd Suite 1300 Schaumburg, IL 60173 misumi.info/discover

The benefits of configurable components are not only the flexibility but the time savings. A part that could take weeks to create with an in-house machine shop can now take just a few days with MISUMI. Our mission is Quality, Cost, and Time – QCT – to provide quality components, at competitive pricing, and with reliable lead times. The design possibilities are endless with MISUMI configurable components.

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Safeguarding Global Health®

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,500 customers across 15 facilities in the United States, Mexico, Asia, and Europe. We have a comprehensive array of over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues. Learn more about Nelson Labs at www.nelsonlabs.com

Nelson Labs brand, we are a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. We provide our customers mission-critical lab testing services, which assess the product quality, effectiveness, patient safety and end-to-end sterility of products. These services are necessary for our customers’ regulatory approvals, product releases and ongoing product performance evaluations.

Nelson Laboratories, LLC 6280 South Redwood Rd Salt Lake City, UT 84123 https://www.nelsonlabs.com/

Nelson Labs serves over 3,500 customers across 15 facilities in the United States, Mexico, Asia and Europe. We have a comprehensive array of over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. Our customers rely on our expertise in their industries to get their medical device and pharmaceutical products to market.

Medical device lab testing services include: microbiology, biocompatibility and toxicology assessments, material characterization, sterilization validation, sterility assurance, packaging validation and distribution simulation, reprocessing validations, facility and process validation and performance validation and verification of PPE barriers and material.

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Custom Medical Extrusions

Incorporated in 2001, New England Tubing Technologies occupies a 14,000 square foot state-of-the-art controlled environment manufacturing facility in the beautiful White Mountains of New Hampshire. Partnering directly with the world’s leading medical electronics and device manufacturers, we design custom braid or spiral reinforced tubing, lined catheter shafts, and hybrid tubing built to exacting specifications.

NEW ENGLAND TUBING TECHNOL OGIES

New England Tubing Technologies 132 North Main Street Lisbon, NH 03585 United States www.newenglandtubing.com

Working directly with clients in the medical electronics and device industries, as well as with other custom industrial and commercial projects, we design and manufacture custom braid or spiral reinforced tubing, lined catheter shafts, multi-durometer and multi-lumen tubing, hybrid tubing configurations, as well as medical braid. Building on the decades of extrusion and wire-processing experience of our parent company, New England Wire Technologies, New England Tubing is advancing innovation in thin-wall, tight tolerance tubing, reinforcing, bonding layers of thermoplastic to fluoropolymer, and braiding all types of round and flat wire.

Our team of design engineers work personally with each customer to develop innovative, one-of-a-kind tubing solutions and custom OEM components from their specifications or to meet unique performance characteristic requirements.

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We also offer a wide range of value-added and post-processing services—tipping, hubbing, flaring, Parylene coating, centerless grinding, and cut to length options. Through true vertical integration of manufacturing processes, New England Tubing Technologies is able to offer customers everything from rapid prototyping services and small quantity orders to full production and value-added services. Let us help you dream beyond today’s technology and achieve the impossible!

New England Wire Technologies is a privately held company with an employee stock ownership program. For 125 years, we have manufactured the most technologically advanced wire and cable in the industry. Our 400,000 square foot, state-of-the-art facility, located in Lisbon, NH, houses manufacturing, R&D, quality/ testing, tooling/machine fabrication and office space. With almost 400 employees, we operate 3 shifts per day, five days a week. As an ISO9001 registered company, we specialize in technical cable solutions, short lead times, and unparalleled customer service.

New England Wire Technologies 130 North Main Street Lisbon, NH 03585 603.838.6624 www.newenglandwire.com

Founded in 1898 in response to the birth of the communication age, today New England Wire is advancing innovation in several industries including medical device and electronics, aerospace, defense, robotics/automation, power generation, and alternative energy. Our capabilities include custom Litz wire, miniature, microminiature, single and multiconductor cables, low-noise, high temperature, coaxial and hybrid cables. Since the 1960’s, we have provided cabling and insulating services to the superconductor industry where our products are integrated into most of the major accelerator projects, ore separator magnets, NMR magnets, and superconducting magnetic energy storage (SMES) magnets.

Through our creative design and development expertise, our engineering staff specializes in product development, concurrent engineering, design for manufacturability, and quick-turn prototyping. Our on-site manufacturing processes include wire drawing, plating, braiding, insulating, and extrusion services. And, since all of our proprietary equipment and tooling is designed and built in-house, we have complete control while also offering quick modifications when needed. Through true vertical integration of the manufacturing processes, our customers’ design-to-market curve is the shortest in the industry!

New England Wire Technologies is committed to being the premier custom cable manufacturer of choice for customers in existing and emerging worldwide specialty cable markets. We help our customers dream beyond today’s technology and achieve the impossible!

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NEW ENGLAND WIRE TECHNOL OGIES

Nitto Kohki USA

Nitto Kohki USA, Inc. designs, develops, engineers, and continuously improves high quality air compressors and vacuum pumps for applications like medical devices, laboratory equipment, applied robotics and environmental sensing equipment.

Nitto Kohki’s unique linear free piston design has one moving part per pump— the piston. The result is a pump with exceptionally reliable performance in tough medical applications. The linear free piston concept enables Nitto Kohki pumps to be smaller and lighter than conventional aerators, allowing designers greater flexibility in system design.

Nitto Kohki USA, Inc. 46 Chancellor Drive Roselle, IL 60172 www.nittokohki.com

Nitto Kohki leads through exceptional product design and execution, with pumps that meet the rigorous demands of today's medical device industry.

Nitto Kohki pumps feature a unique, patent-awarded linear-motor-driven free piston system that is globally proven in the medical device, instrumentation, and other critical industries. This unique design theory eliminates the wear components typically found in conventional air compressors and vacuum pumps, such as crank shafts, connecting rods and ball bearings. The only moving part is the piston! Also eliminated is the need for any lubrication. Fewer parts translate into fewer problems.

WHY DESIGNERS CHOOSE NITTO KOHKI

• Exceptionally reliable performance for critical applications

• World class manufacturing expertise ensures consistent product quality

• Clean, simple design maximizes performance, minimizes maintenance — adding value over the integrated product lifecycle.

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Award-Winning Electronic Enclosures

OKW Enclosures, Inc. is a specialist manufacturer of enclosures for OEM electronics. The company’s extensive and award winning program includes pocket-size, handheld, desktop, portable, wall mount and DIN rail enclosures, plus accessories and a large range of tuning knobs. OKW also offers a comprehensive customizing service which can supply the enclosures fully finished with all the modifications necessary for mounting the customer’s components. Options include CNC machining, custom colors and materials, digital printing and much more. Free samples are available for evaluation.

OKW manufactures advanced enclosures for today’s electronics equipment.

The enclosures can be supplied fully customized to customer specifications.

The range includes the following popular versions:

Handheld Enclosures

Modern and ergonomically designed enclosures for mobile electronics used both indoors and outside. Standard features include recessed tops for locating membrane keypads, battery compartments for AAA, AA and 9V cells, integrated cable glands, infra-red versions, sealing kits up to IP 65, desk stations for charging and wall holders for storing. Many of these enclosures can also be used as wearable devices with the optional wrist/hand straps, belt/pocket clips and lanyards.

Instrument Enclosures

Stylish high quality enclosures for table-top and portable electronic instruments. Large range of designs in plastic or aluminum with removable front panels or sloping front sections. Options include aluminum or plastic front panels recessed for membrane keypads, ventilation slots, battery compartments, bail arms or integrated handles and non-slip feet.

Wall Mount Enclosures

Advanced wall mount enclosures for indoor and outdoor electronics equipment. Stylish and modern design sets these enclosures apart from the norm. Standard features include hidden fixing screws for a clean and tamper-proof assembly, recessed top for a membrane keypad, standard ingress protection up to IP 67 ( NEMA 4X) and hinged solid or transparent lids.

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OMRON Industrial Automation, powered by the InnovativeAutomation

Omron Automation is an industrial automation partner that creates, sells and services fully integrated automation solutions that include sensing, control, safety, vision, motion, robotics and more. Established in 1933 and currently headed by President Yoshihito Yamada, Omron’s 30,000 employees help businesses solve problems with creativity in more than 110 countries.

OMRON tackles manufacturing challenges through three innovations: “Integrated” (control evolution), “Intelligent” (developing intelligence through ICT) and “Interactive” (human-machine collaboration).

Integrated

Enabling easy replication of ultra-highspeed, precision control for anyone

OMRON finely coordinates its extensive collection of more than 200,000 products with the unique control software to provide more than 170 kinds of control applications that enable easy replication of advanced craftsmanship, such as ultrahigh-speed machine control and ultra-high precision processing.

Intelligent Systems that learn and develop by making full use of production site data

Our solutions visualize the production site through nearly 100,000 IoT control devices and make full use of production site data with unique AI technology. Our goal is to create downtime-free production lines and defect-free production facilities through measures such as remote predictive maintenance and near-human sensory inspections.

Interactive

Ultra-flexible production where machines open new possibilities for human workers

OMRON solutions enable coordination between machines and humans by coupling human labor with IoT, collaborative robots, and other technology. Our goal is to realize an ultra-flexible means of production where machines understand and assist humans.

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OMRON Industrial Automation Contact information here

Medical power leader

P-DUKE technology

P-DUKE was founded in 1992, manufacturing based in Taiwan, is fully devoted in research & development, production that provides complete sales, technical service of DC/DC converters and AC/DC power supply also custom power solution. Specializes in particular sectors such as medical and railway applications where require high standard and attention on safety the most. Main Business is over Europe, America, and pacific Asia. Accumulating abundant experience within 30 years, has opened up product awareness becoming an important role in the global market.

P-DUKE offer broad range of medical power products. Including 1-60W DC to DC converter for CF type devices and 15-450W AC to DC power supply for B/BF type devices in compact design. The manufacturing facilities are acquired ISO 9001 manufacturing, ISO 13485 quality and 14971 risk Management System certification for medical device. Offering high IEC/ EN 60601-1/ ES 60601-1 medical certificated reliable power supplies.

P-DUKE Technology Co.,Ltd. No.36,22nd Rd.,Taichung Industrial park Taichung 40850 Taiwan www.pduke.com

P-DUKE USA California (909) 598-5000

The products own many design and manufacturing process patents, always bringing the latest technology which won the Innovation Award of TAITRONICS and good reputation in the industry.

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High-performance Motion Control for Healthcare

Performance Motion Devices, Inc. (PMD) is a world leader in motion control technology for life sciences, medical devices, robotics, and healthcare automation. PMD delivers a broad range of advanced electronic motion control products including integrated circuits (ICs), digital amplifiers, digital drives, and boards to a worldwide customer base. With over 6.5 million motors controlled by PMD solutions, they distribute products to healthcare OEMs around the globe.

Performance Motion Devices, Inc. is an ISO 13485:2016 and ISO 9001:2015 certified company.

PMD’s unique motion control products excel at Brushless DC, DC Brush, and step motor control. These controllers provide profile generation, servo loop closure, advanced commutation and current control, and much more. With PMD’s Developer Kits and C-Motion programming language you’ll be tuning your system and building your application in no time.

MAKE EVERY MOVE COUNT

PMD helps engineers solve their toughest motion control challenges. Discover how PMD’s world-class motion control solutions increase performance, improve reliability, and help get your products to market faster.

• High-performance motion control ICs, modules, and boards

• Easy-to-use motion control development tools

Performance Motion Devices, Inc. (PMD) 80 Central Street Boxborough, Massachusetts 01719 https://www.pmdcorp.com

• A single common motion language for all products

PMD’s motto, Motion Control At Its Core, reflects its uniquely powerful strategy of placing motion control ICs at the core of all of their products so that they speak one common motion language.

NEW ULTRA-COMPACT MOTION CONTROLLER

Meet the new PCB-mountable intelligent drive that provides advanced motion control features, flexible network connectivity, and advanced power amplification.

• Fully Programmable

• S-curve Profiling

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• 1 KW+ Power Output

• Supports Brushless DC, DC Brush, and step motors

Visit www.pmdcorp.com/nseries to learn more.

PTC enables global manufacturers to realize double-digit impact with software solutions that enable them to accelerate product and service innovation, improve operational efficiency, and increase workforce productivity. In combination with an extensive partner network, PTC provides customers flexibility in how its technology can be deployed to drive digital transformation – on premises, in the cloud, or via its pure SaaS platform. At PTC, we don’t just imagine a better world, we enable it.

The global pandemic has impacted the entire medical sector. For medical device manufacturers, it has become even more critical to service equipment from offsite, whether due to a hospital lock-down or an internal concern over technician safety. And now, more than ever, medical equipment downtime is more than an inconvenience—it can directly compromise patient outcomes during a time of extreme stress on healthcare systems.

PTC 121 Seaport Blvd Boston, MA 02210

www.ptc.com/medical-device

PTC’s Internet of Things solutions provide essential support for medical device makers as they shift to remote service models that were nice-to-have before the pandemic—and are now business critical. With remote condition monitoring providing real-time insights and remote service capabilities enabling real-time repair, technicians are able to reduce medical equipment downtime, improve first-time-fix rates, and support healthcare providers who are under unprecedented pressure. Service parts planning made even more effective through off-site data connectivity helps ensure the right parts are available at the right location, for the right problem, at the right time. And augmented work instructions and remote assistance provide the just-in-time coaching needed to help factory field teams, 3rd party service organizations, or even users themselves to keep equipment running to specification. PTC’s IoT service solutions provide crucial protection for both technicians and patients—ensuring that medical device service teams can support medical practitioners by safeguarding the equipment that saves lives.

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PTI Engineered Plastics is a custom injection molder and manufacturer of plastic components and assemblies. As a diverse plastic injection molding company, PTI services the medical, defense/aerospace, consumer products, and electronics industries.

Medical Defense/ Consumer Electronics Aerospace

Whether it’s low or high volume, simple or complex, prototype or production, PTI can deliver. Our 160,000 sq. ft. facility in Macomb, Michigan offers 4,000 square feet of ISO Class 8 Cleanroom, an array of secondary services and is fully versed in IQ/OQ/PQ validation protocol. Our facility was specifically designed and technically equipped to deliver our customers a comprehensive experience.

Certifications

PTI is FDA, UL, and ITAR registered and ISO 13485, ISO 9001, and MedAccred AC8160 certified.

PTI Engineered Plastics 50900 Corporate Drive Macomb, MI 48044 586.263.5100 teampti.com

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Design

PTI can take you from mind to manufacturing® starting with an in-house industrial design and development studio. PTI Design can optimize your design or take your idea through a five-phase process to ensure your product has a competitive edge in the market.

Tooling

The PTI Tool Room is comprised of 35 mold makers and highly skilled mold build specialists, using a fully integrated network of 25 CNC machining centers. In addition to seven Makino high-speed vertical machining centers, PTI has a 4-axis horizontal Makino and two 5-axis machines offering the latest in high-speed machining technology: a GROB 550 and a Hermle C400. Each of the ten high-speed CNC machining centers utilizes thermal shrink collet tooling for precision and accuracy. Within the EDM department are four high-speed graphite robotic-fed machining centers with spindle speeds up to 54,000 RPM. PTI has a total of four CNC carousel-fed sinker EDM machines as well as wire EDM capabilities.

In terms of tooling, PTI incorporates many materials based on the needs of the program. These materials include aluminum, P-20, NAK 55, hardened steels and varying grades of stainless. Different types of injection molds include unit-mold insert, free-standing, and shuttle bases; all are available in single cavity and multiple cavity options. PTI’s P3™ Proprietary Process can create production-ready prototypes to get parts to market quick, and to sustain product orders well into the life of a program.

Production

PTI’s Production floor currently hosts 60 injection molding machines ranging from 38-300 tons of clamping force, with 0.09-55.5 oz. shot capacity. Manufacturing capabilities include low and high volume production, insert/overmolding, high-temperature molding, contract manufacturing, assembly and packaging.

Smart Factory Technology

PTI has 20 Arburg presses that are all equipped with a host computer system. These “smart machines” provide numerous benefits from improved efficiency, safety, security, cost reduction and performance.

Cleanroom Manufacturing

Services within ISO Class 8 Cleanroom include injection molding, assembly, secondary operations and packaging.

Secondary Services

PTI offers an array of secondary services such as plastic joining, laser marking, pad print and assembly.

Validation

PTI is fully versed and staffed in the IQ/OQ/ PQ validation processes.

Your Full-Service Engineering Partner

PSN Labs is an Engineering Services firm, specializing in all areas of product development with three distinct but cohesive laboratories: Engineering Lab, Testing Lab, and Processing Lab. Our engineers and scientists have decades of experience within their field and work within as well as across each lab to bring products to market with ease and confidence.

PSN Labs offers comprehensive services with uncompromising quality. Our experience and expertise crosses over a wide range of industries, products, and manufacturing processes, allowing our teams to be a best-in-class choice to help determine and correct the risks associated with medical device manufacturing.

PSN Labs is a leader in biocompatibility and toxicology for the medical industry. Within our ISO/IEC 17025:2015 accredited Testing Lab, PSN Labs has a dedicated team of biocompatibility experts, who are involved at every stage of the development process for medical devices and technology.

Biocompatibility testing (ISO 10993/ ISO 18562) is an important requirement for all medical devices that are patient contacting. Our team stays involved from the very onset of development to ensure the material choices, design, and processing are safe for patients and follow all requirements under the FDA and other regulatory bodies. Whether testing current devices or designing something new, this team will be involved the whole way, including assisting in the FDA 510(k) submission.

PSN Labs 5368 Kuhl Road ERIE, PA 16510 https://www.psnlabs.com/

There is no one easy answer to toxicology or biocompatibility. Each program is a customized test plan created for each unique device, with test fixtures to isolate the data for just the device components required. Our team of scientists and engineers are trained to isolate confounding variables and provide clear analysis to guide the commercialization of new medical devices. We are passionate about patient safety and ultimately want to ensure that the medical devices and technology on the market are going to increase the quality of life - both in the short and long term - for those who are often the most compromised.

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Qosina is a leading global supplier of more than 5,000 OEM single-use components to the medical and pharmaceutical industries. Our mission is to provide the best customer experience possible by helping our customers find, order and receive quality medical components quickly and accurately. We provide practical solutions to meet the changing needs of today’s engineer through innovation, technology and continuous improvement.

Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified and operates in a 95,000 square-foot, climate-controlled facility that includes an ISO Class 8 Clean Room.

Qosina helps medical device engineers get their products to market faster and more efficiently by offering free samples of our products; downloadable 3D CAD models and technical product documentation; modification of existing molds; and new product design and development.

Purchase from Qosina to eliminate the cost of tooling your own components. If you need an item that is not a stock product in our inventory, we will work to develop the part to your exact specifications. We’re committed to providing you with high quality products that meet your expectations and comply with industry standards. Download a pdf of our vast product catalog, which includes full-scale images on a one-centimeter grid.

Our Extensive Component Inventory

Adhesives

Applicators, Swabs & Brushes

Bags

Caps Chambers Clamps & Clips Containers

Connectors

Dilators & Introducer Sheaths Dispensers

Drapes, Towels & Bandages

ENFit® Extension Lines Filters

Qosina

2002-Q Orville Drive North Ronkonkoma, New York 11779 631.242.3000 www.qosina.com

Guide Wire & Catheter Accessories Injection & Sampling Ports Needles

NRFit™ O-Rings Ports & Flanges Scoops & Spoons

Spikes

Sterilization Supplies Stopcocks

Syringes Tools Tubing Valves

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Visit qosina.com today and discover countless solutions to get your project off the ground and into production. We look forward to being your partner in growth, innovation and success.

www.medicaldesignandoutsourcing.com

The Leader in Manufacturing for Life Sciences

Founded in 1987, Resonetics is a pioneer in advanced engineering, prototyping, product development, and manufacturing solutions for the life sciences industry. Resonetics is a leader in laser processing, centerless grinding, nitinol processing, thin-wall stainless steel & precious metal tubing, photochemical machining, microfluidics, sensor solutions, and medical power.

With strategically located AGILE Product Development teams and Lightspeed Labs, Resonetics is committed to quality, speed, innovation, and a great customer experience. The company is ISO 13485:2016 certified with 14 facilities and more than 2,000 associates in the United States, Canada, Costa Rica, Israel, and Switzerland.

26 Whipple Street Nashua, NH 03060 800.759.3330 sales@resonetics.com resonetics.com

Lightspeed Lab: Industry Leading Prototype Solutions

The Resonetics Lightspeed Lab is a group of engineers and technicians deploying dedicated, state-of-the-art equipment to provide quick-turn prototyping solutions for the medical device and advanced diagnostic markets. Each Lightspeed Lab has technology expertise and develops manufacturing processes that can easily scale to high-volume production, which enables our customers to develop and launch products in record time.

Lightspeed Lab areas of expertise:

• Laser Cutting & Welding

• Laser Cut Tubing

• Laser Ablation

• Centerless Grinding

• Photochemical Machining

• Sensors

• Nitinol Processing

• Microfluidics

• Medical Batteries

The Lightspeed Lab team is comprised of leading industry experts who partner with customers early in the development process and use the latest capabilities and advanced micro-manufacturing processes. All projects will receive detailed feedback on design-formanufacturability so that the program will be cost effective in production.

AGILE Product Development

The AGILE product development team at Resonetics can support customers with different levels of product development services. With deep expertise in catheter-based delivery systems, electrophysiology, cryotherapy, and implants, our dedicated team of engineers will work collaboratively with you to bring elegant and disruptive medical solutions to life, from initial design and prototyping to validation and commercial scale-up.

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• CNC Machining

Rotor Clip is a globally recognized manufacturer of high-quality retaining rings, spiral rings, wave springs and hose clamps. Companies across a broad range of industries rely on Rotor Clip products, value-added services and expertise to build reliable and safe equipment for virtually any application.

Rotor Clip operates in the US, UK, Germany, China, and the Czech Republic - providing worldwide service to its customers. Recognized worldwide, Rotor Clip has received numerous quality awards from major OEMs, automotive manufacturers, and distributors. Rotor Clip also produces its products under IATF 16949, ISO 9001, AS9100, ISO 14001, ISO 13485, and TISAX standards.

INNOVATION EVERY DAY: ROTOR CLIP

We not only manufacture quality products, but offer a wide range of parts in different sizes, finishes and styles. Our products are made in the USA and EU including retaining rings, spiral rings, wave springs and hose clamps.

Rotor Clip 187 Davidson Ave Somerset, New Jersey 08873 www.rotorclip.com

Wave Springs - Rotor Clip manufactures the largest range of Wave Springs in the market. We have the capability to make Wave Springs from .118” to 25” O.D.

Spiral Rings - Spiral Rings are axially installed into machined grooves in housings/bores or on shafts to retain assemblies. They provide 360° contact with the groove and offer more clearance than a tapered section ring. Made from .118” to 25” O.D.

Tapered Section Retaining Rings – Inch, DIN, ANSI metric, and JIS retaining rings to world standards. We make over 50 different styles, and well over 1000 part numbers.

Hose Clamps - Perfect fit every time, uniform hose pressure, and a lower cost and weight leaving more budget room.

Custom Material and Finish Options - We can produce these parts in Carbon Steel, Stainless Steels Alloys, Beryllium Copper, Phosphor Bronze, and Specialty Steel Alloys. We also have several finishing options to withstand almost any condition: including many RoHS and REACH compliant options.

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SCHURTER Components and HMI Innovation

The SCHURTER Group is a globally successful Swiss technology company ensuring clean and safe supply of power, ease of use and sophisticated overall solutions. Known for its innovation, manufacturing and distribution of Circuit Protection, Power Entry Modules, EMC Filters, and Switch Components and HMI Solutions, SCHURTER impresses its customers with agility and excellent product and service quality. Specific market focus is in the areas of medical, automotive, avionics and space, data and communication, energy and the greater industrial market. Committed to customers around the world, directly and through our partner network, SCHURTER’s expertise, financial independence, innovative strength, distinctive corporate culture, and environmental practices sustain SCHURTER into the digital future, together with its partners.

In addition to the distribution of electronic components, SCHURTER Inc located in Santa Rosa, CA now offers in-house manufacturing and design services for projected-capacitive (PCAP) touch screen solutions. We work with you to develop an HMI system that is precisely tailored to your complex application requirements. With targeted advice, knowledge and creativity, we are your perfect partner to design, develop, and produce the best solution for your application.

SCHURTER offers state-of-the-art optical bonding as part of your HMI Touchscreen Solutions. Here are some advantages:

• Best readability

• Improved touch performance

SCHURTER Components and HMI Innovation

447 Aviation Blvd Santa Rosa, CA 95403 www.schurter.com (800) 848-2600

Commitment to Our Customers

• Increased robustness

• Protection against dirt and dust particles

• Qualified UV stability

• No condensation

• Reduced reflections

• Increased shock and vibration resistance of the touch panel

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At SCHURTER, success is based on more than just technological achievements. After all, it is the people here who provide the highest degree of product benefit and safety to our customers and, in turn, their customers.

Setting Ideas Into Motion

Stock Drive Products/Sterling Instrument (SDP/SI) makes it easier for OEMs to get their products to market by designing and delivering precision components and complex drive assemblies while managing costs and inventories. Well known as the one-stop-shop, we provide mechanical and electromechanical components, engineering development, precision manufacturing, and problem-solving customized solutions.

Established in 1950, we are a proven partner to the most recognized names in medical, aerospace, defense, and robotics industries providing innovative solutions, world-class quality, and engineering support from concept to completion. We look forward to working with you!

Medical Applications include:

• Minimally invasive & surgical gear drivers

• Robotic surgery

• Pharmaceutical processing & packaging

• Drug delivery systems

• Therapeutic & assisted living devices

Stock Drive Products/ Sterling Instrument 250 Duffy Avenue Hicksville, NY 11801 USA Web: www.sdp-si.com Email: sdp-sisupport@sdp-si.com Phone: 516-328-3300 Toll Free: 800-819-8900 Fax: 516-326-8827

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Proven Performance for Medical Applications

SDP/SI has over 70 years of experience in engineering development and precision manufacturing for a diverse range of industries, including medical, surgical robotics, and healthcare. Combining our engineering expertise in small power transmission and motion control applications with a state-of-the-artmanufacturing facility ensures our customers receive components and assemblies that meet their specific needs. SDP/SI is ISO 9001:2015 + AS9100D certified, ITAR, Reach, and RoHS compliant.

Offering a comprehensive selection of mechanical and electromechanical components, SDP/ SI products are available with a wide range of standard features for easy integration intended for precision applications. SDP/SI creates precision gears, timing belt & pulley drive systems, mechanical components, and customized solutions.

SDP/SI offers significant custom engineering and manufacturing capability. As a trusted partner to companies such as Medtronic, Intuitive Surgical, Abbott Laboratories, Hologic Surgical Products, Siemens Healthcare, and more we develop and manufacture the components and assemblies that ensure success for your device.

Visit www.sdp-si.com to find detailed product specifications, custom capabilities, 3D CAD models, product literature, and helpful calculations.

SigmaTron International is a full service EMS provider with a network of manufacturing facilities in the United States, Mexico, China and Vietnam that enables us to provide a wide range of nearshore and offshore manufacturing options. We focus on companies who want customized service plus a scalable global manufacturing footprint. All of our facilities are registered to ISO 9001 and those focused on medical products are registered to ISO 13485. Our Union City, CA facility holds a California FDB Device Manufacturing License.

Services include:

• Engineering support

• NPI/Prototyping

• Supply chain management (Includes IPO in Taiwan)

• PCBA assembly

• Testing

• System assembly

• Box build and pack-out

• Fulfillment/distribution

SigmaTron International 2201 Landmeier Rd

Elk Grove Village, IL 60007 sigmatronintl.com

SigmaTron’s advantages for medical customers include:

• Agile PLM-driven project launch support

• Access to a global network of facilities in the U.S., Mexico, China and Vietnam

• Ability to support high mix, low-to-medium volume production, as well volume production

• 24/7 visibility into project status around the globe via our proprietary SCORE system

• A supply chain management strategy that supports material integrity while addressing constraints

• Robust systems for serialization, traceability and device history recordkeeping

• An experienced team capable of supporting your project’s changing needs over time

We’ve built our business around mid-to-high volume accounts who want Tier One caliber solutions, but truly customized service and responsiveness. You’ll have access to global manufacturing options that support both nearshore and offshore strategies plus a trusted partner who truly values your business.

Our medical product manufacturing experience includes:

• Clinical Diagnostic Systems

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• Instruments

• Life Support System Battery Packs

SigmaTron International’s business model is focused on providing service excellence, superior quality and manufacturing solutions tailored to each customer’s needs. We strive to add value at each step of your product’s lifecycle from product design through production and postmanufacturing support. Whether you need prototype or high volume production nearshore or offshore, we have a solution.

Vacuum Heat Treating for the Medical Industry

Solar Atmospheres is one of the world’s largest providers of commercial vacuum heat treating services, serving over 18 metal working industries including aerospace, medical, and power generation. Solar’s thermal processing produces bright, scale-free parts with minimal distortion. With over 60 furnaces ranging from lab sized to 48 feet long with a 150,000 pound workload capacity, Solar can efficiently handle any size job.

Solar operates plants in Eastern and Western Pennsylvania, California, South Carolina and Michigan. Nadcap, ISO 9001, AS9100, ITAR, and MedAccred Certified.

Solar Atmospheres 1969 Clearview Road Souderton, PA 18964

https://solaratm.com

Lives depend on your medical components, so partner with a heat treater that you can depend on. Solar’s state-of-the-art services include vacuum heat treating, brazing, carburizing, nitriding and advanced processing of raw materials. From annealing to case hardening, we’ll help assure that your parts perform reliably in critical situations.

At Solar Atmospheres, your stringent medical specs get the specialized expertise they deserve. Harness our leading-edge vacuum technology for clean, bright, safe parts. Our world-class equipment and expertise give you precise process control and repeatability for uncompromised quality.

Solve your toughest thermal processing challenges with innovative, custom process solutions from our brain-trust of metallurgists, chemists and engineers. Our commitment to taking on the challenge of new types of work is evidenced by the R&D we perform for universities and national laboratories.

Solar Atmospheres operates a MedAccred accredited metallurgical testing services laboratory, utilizing Struers Microhardness testers which can read both Knoop and Vickers scales without recalibration. Computerized stage control and indentation measuring systems significantly improve test accuracy, precision, and repeatability.

Get results that exceed your expectations and the responsive service you deserve at Solar Atmospheres.

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40-Plus Years of Proven Shock, Vibration & Noise Reducing Solutions

Sorbothane, Inc. serves widely varied market segments with Standard and Custom Engineered components.

MARKETS SERVED

TRANSPORTATION SHIPPING & LOGISTICS

• Sorbothane® Safeguards Precious Cargo

PRECISION LABORATORY EQUIPMENT

• Sorbothane® Isolates Disruptive Vibration

MOBILE ELECTRONIC DEVICES

• Sorbothane® Attenuates Impact Shock & Isolates Vibration

CONSUMER & COMMERCIAL PRODUCTS

• Sorbothane® Damps Unwanted Vibration & Noise

INDUSTRIAL & MANUFACTURING EQUIPMENT

• Sorbothane® Extends Equipment Life

AEROSPACE & AERONAUTICAL

• Sorbothane® Protects Critical Components

MEDICAL EQUIPMENT

• Sorbothane® Protects Performance

SPORTING GOODS & FITNESS

• Sorbothane® Protects, Cushions & Comforts

Sorbothane, Inc. is located in Kent, Ohio and operates 10 specialized pouring machines. With 64,000 square feet of manufacturing space and supply support systems in place, the Sorbothane team stands ready to meet any production need. Sorbothane, Inc. has an engineering design staff that specializes in shock and vibration solutions plus an in-house testing and quality assurance lab.

Sorbothane® is a proprietary viscoelastic material that has been specified by engineers worldwide for over three decades. Sorbothane® is a highly damped polymeric solid that “flows” like a liquid under load. Its superior damping and isolation properties have been scientifically and real-world proven. Sorbothane® is ideal for engineering design applications requiring shock absorption, vibration isolation and acoustic damping. Produced in a durometer range from 25 to 85 - Shore 00 scale Sorbothane® is considered a super soft polyurethane.

Unique applications call for innovative solutions. Standard Sorbothane® parts and custom engineered solutions are available to meet individual product objectives.

STANDARD Sorbothane® PRODUCTS

Sorbothane, Inc. offers an extensive line of standard Sorbothane parts.

These standard products have been developed over 40 years and are selected for their specific shock absorbing and vibration isolating applications.

The Sorbothane® Standard Products Guide is available at www.sorbothane.com or by contacting Sorbothane, Inc. directly.

CUSTOM Sorbothane® SOLUTIONS

Unique applications call for very innovative solutions. Our engineering team will help design the custom Sorbothane® component perfect for your individual product specifications. Since 1982, Sorbothane, Inc. has engineered individualized shock and vibration solutions for numerous and diverse markets.

Our goal is to protect the performance and integrity of your product.

For over 40 years Sorbothane, Inc. has been - and will continue to be - the innovative and trusted choice of engineers worldwide for developing materials and components that isolate vibration, attenuate shock and damp unwanted noise.

Sorbothane Passes the Egg Smash Test https://youtu.be/RVE5b3BzSWQ

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STEUTE has specialized in designing and manufacturing off-the-shelf-custom built (with no tooling or NRE costs) and fully-custom cabled and wireless, medical-grade foot switches expressly for medical device OEM’s for more than 60 years.

Our staff of over 400 employees understands your need to demonstrate your medical devices’ superiority with an easy-to-use foot control that is ergonomically-designed for operator comfort and optimum functionality. With offices in 30 countries, our worldwide team is ready to share our ideas for realizing a human interface that optimizes your device’s performance and market appeal.

STEUTE has been designing and manufacturing medical-grade foot switches expressly for medical device OEMs worldwide since 1952. During that period we have tooled a wide range of platforms/consoles, actuators, detents, carrying handles, and analog and digital output devices. These components, coupled with the wide array of connectors, cables, strain reliefs and our in-house graphics capabilities, has enabled us to address an infinite number of medical device OEM foot switch needs with our unique “off-the-shelf-custom” program.

Within this program we can satisfy a wide variety of performance requirements, with a fullycustom designed and built foot switch that requires no tooling investment or NRE costs to the medical device OEM.

Each unit is developed with the following key objectives:

• Optimum medical device functionality

• Operator comfort and ease-of-use

• Aesthetically complimentary to the OEMs device design

• Full compliance with IEC, UL, CSA and FCC requirements

• MDR compliant, available with MDR documentation package

In addition, STEUTE has pioneered the use of wireless foot switch technology expressly for use in medical environments. Now into our fourth generation, we offer our proprietary 2.4 GHz frequency-hopping system featuring:

• Safe, noise immune operation

• Encrypted communication protocols

• Low power consumption

• Real-time battery charge status

• Optional “sleep-mode”

• Fast wake-up time

• Worldwide acceptance

STEUTE Meditech, Inc. 901 Ethan Allen Highway, Suite 102 Ridgefield, CT 06877 203.244.6302 Email: info@steutemeditech.com www.steutemeditech.com

Today we have thousands of safe, reliable cabled and wireless foot switches installed in diagnostic and therapeutic applications worldwide.

Call for a no-obligation design consultation, or a complimentary evaluation sample.

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www.medicaldesignandoutsourcing.com

Tegra Medical makes products used in a variety of markets including:

• Orthopaedics

• Cardiac care

• Oncology

• Neurology

• Ophthalmology

• Radiology

• Pain management

• Diabetes and other medical specialties

The types of procedures often include arthroscopy, endoscopy, joint reconstruction, biopsies, and drug delivery using a wide range of devices such as implants, needles, cannulas, fixation systems, probes, wires, catheters, stylets, mandrels and many more. See our website for details.

Tegra Medical provides true end-to-end contract manufacturing solutions, handling all the steps of creating your complete device or component from prototyping to full production. Our customers look to us to manufacture everything from complex components to finished devices – from the sharp “business end” to the molded plastic handle – including assembly, sterilization and packaging. We are headquartered near Boston and have manufacturing facilities in several U.S., Costa Rica, Europe, and Asia locations.

Manufacturing Capabilities

Tegra Medical has the expertise to manufacture complete, fi nished medical devices, particularly those with intricate tolerances or that require combining non-traditional with common technologies. We are renowned for keeping devices sharp throughout the entire manufacturing process. Our vast range of manufacturing technologies includes CNC milling/turning, Swiss machining, gundrilling, wire and sinker EDM, laser processing, CNC grinding, electrochemical cutting and grinding, injection molding (including micro), metal forming, and Nitinol shape setting, as well as cleanroom molding and assembly.

GENESIS Tech Center® Product Development Services

Work with Tegra Medical’s GENESIS Tech Center team to give your product a smooth launch to market. We’ll help you reduce production costs, increase quality, and shorten the development cycle of your medical device. Our product development services include Design For Manufacturing (DFM), prototyping, pilot production, and more.

Tegra Medical

16 Forge Park Franklin, MA 02038 info@tegramedical.com T: 508.541.4200 www.tegramedical.com

Wire and Tubing for Device Development

Tegra Medical offers wire and tubing for your catheter and other medical device development projects. Order in-stock items from our Quick Wire & Tubing store and we’ll ship them within 24 hours. And to make your life easier we also offer a wide variety of custom finishing and mandrels. Visit our online store to place your order or request a quote for custom finishing.

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Where medical devices come to life, Tegra Medical, and GENESIS Tech Center are registered trademarks of Tegra Medical. Tegra Medical is a member of SFS.

South Africa National Convention Bureau

The South Africa National Convention Bureau (SANCB) is a ‘one-stop solution’ for independent information and assistance, giving neutral advice on all aspects of hosting and organising any business event in South Africa. You can find decent conference venues, convention centres, hotels and bed and breakfasts anywhere in the world. In South Africa, we have plenty of that, too. But if you’re looking for a destination where you can be inspired by the people, sights, sounds and unrivalled tenacity that has seen so many thrive all over the world, South Africa is everything you’re looking for and more.

As the South African National Conventions Bureau, we are passionate about our country. But promoting South Africa as an ideal business destination is the easy part. What we really want to show the world is that when it comes to business travel, South Africa is much more than simply an ideal.

South Africa is a nation at the forefront of cutting-edge medical procedures. The country’s history of excellence and innovation in healthcare makes it a serious contender in the health tourism industry, one of the fastest-growing tourism trends. Not only are people coming from afar for medical forums but they are also seeing South Africa as the ideal place to recoup and recover after medical procedures due to the country’s modern medical procedures and affordable post-surgery tours and packages.

South Africa National Convention Bureau Bojanala House 90 Protea Road Chislenhurston, Sandton JOHANNESBURG South Africa

https://sancb.southafrica.net/delegateboosting

South Africa also has the largest pharmaceuticals market in Africa, valued at over USD3.2billion in revenue. The country also has a population with a high genetic diversity, which makes it a particularly advantageous location for life sciences research and application in the long term.

With all this in mind, the fact remains that South Africa is the ideal destination for medical conferences, meetings and symposiums due to its meaningful medical history and significant contributions to the field. With eight established and renowned medical schools, each under the support of public universities; it is no wonder then that South Africa is considered a world leader in medical practices and methods.

medicaldesignandoutsourcing.com/leadership

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Your Partner for Life-Changing Technologies

Trelleborg Healthcare & Medical helps pharmaceutical and medical device companies improve patient quality of life by partnering in all stages of development, from concept to serial production to create engineered polymer solutions for demanding applications. Trelleborg’s global footprint is backed by experts with 30-plus years of industry experience and a portfolio of capabilities including silicone molding, extrusion, sheeting, dipping and coating, overmolding, plastic injection molding, multicomponent manufacturing, drug-eluting technologies, engineered coated fabrics and other technologies. Additionally, customers have access to a variety of materials, such as Liquid Silicone Rubber (LSR), thermoplastics, black rubber, bioresorbables and other polymers and elastomers.

Trelleborg has expanded its capabilities and offerings to medical device customers with the recent EirMed and Minnesota Rubber & Plastics (MRP) acquisitions. These acquisitions enhance Trelleborg’s ability to partner with customers on projects involving thermoplastic and rubber injection molding, assembly, packaging, bioresorbables and more. The acquisitions further Trelleborg’s ambition to provide innovative, custom solutions to customers by accelerating product development and strengthening research and development.

Trelleborg can now leverage MRP’s established excellence in polymer and thermoplastic components and its strategically located manufacturing facilities that complement Trelleborg’s manufacturing network. MRP production facilities in the US, Mexico, Europe, and China enable Trelleborg to have a manufacturing presence close to medical device customers. Local manufacturing decisions can be made per component, depending on part complexity, labor content, supply chain risk level, demand, and more.

By the numbers

Trelleborg Healthcare & Medical 1550 Utica Ave South Suite 555 Minneapolis, Minnesota 55416 www.trelleborg.com/healthcare

Accounting for its added reach with MRP, Trelleborg now has 10 research and development centers, 41 manufacturing facilities specializing in market-leading solutions, 61 Customer Solution Centers offering local engineering and support services, one Customer Innovation Center, five logistics centers, and three ServicePLUS Centers.

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Trelleborg Expands its Offerings through Acquisition

EXPERTISE & SCALE YOU CAN COUNT ON

Viant is a trusted global design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, endto-end integration, technical expertise, and relentless focus on customers and operational excellence. With nearly 6,000 associates across 25 locations worldwide, we offer a unique combination of smallcompany service and attention with big-company resources. Our customers count on us to help bring mission-critical projects to life.

• 25 Locations Worldwide

• 2.1M+ sq ft of Facility Space

• 300K+ sq ft of Cleanroom Space

• 6000 Associates

Viant 2 Hampshire St

Foxborough, MA 02035

https://viantmedical.com/

YOUR TRUSTED GLOBAL MEDTECH PARTNER

Our vision is to be your trusted design and manufacturing services partner. We know the quality of care patients receive can depend on the quality of your design and manufacturing partner. At Viant, we take that seriously. That’s why we’ve created a network of resources and expertise to support your biggest design and manufacturing challenges. We’re in it for life.

END-TO-END & EVERYTHING IN BETWEEN

Viant’s end-to-end solutions bring all the products and services you need together, under one roof. Whether it’s across the entire lifecycle -- or anywhere in between -- our vertical integration allows you to streamline your supply chain and reduce costs.

• Design & Development

• Materials Expertise (Thermoplastics to Elastomers to Metals)

• Complex Components

• Manufacturing & Assembly

• Finished Device Services

100% FOCUSED ON MEDTECH

We have a deep understanding of healthcare markets and clinical applications including surgical, orthopedics, cardiac & interventional, bioelectronics, drug delivery, bioprocessing, diagnostics and lab, and respiratory, monitoring and patient care.

SMALL COMPANY SERVICE & ATTENTION, BIG COMPANY RESOURCES

At Viant, we have a relentless focus on excellence and serving our customers. We pair enterprise support and best practices with agile, local resources your team can count on every step of the way. We’re more than a contract manufacturer, we’re your partner.

medicaldesignandoutsourcing.com/leadership

Voting for this company will identify it as a leader in the medical technology industry.

Innovative Plastics Solutions... Sustaining and Saving Lives.

Westfall Technik® delivers end-to-end contract manufacturing solutions for the complete lifecycle of injection molded plastic parts with a relentless focus on healthcare across a variety of markets and end-use applications. Westfall Technik’s competitive advantages include modern automation systems, correlative molding processes, and effective industry 4.0 concepts utilizing our proprietary Stacked Integration model to ensure single point of accountability and increased customer value. The results for brand owners include high quality, excellent value, fast response for shorter time-tomarket and scale, ensuring reliability from a team you can trust to solve complex challenges enabling our customers to meet their desired initiatives.

Westfall Technik® is a global company delivering end-to-end manufacturing solutions for the complete life cycle of molded plastic parts. With 18 locations, Westfall has become a leader in injection molding and assembly for Healthcare and Pharma. We are the only custom injection molder capable of delivering fully integrated manufacturing solutions in the healthcare vertical market.

Westfall serves multiple core healthcare markets:

Westfall Technik 3883 Howard Hughes Pkwy. Suite 590 Las Vegas, Nevada 89169 https://www.westfalltechnik.com

• Medical Device (Class I, II, III)

• Consumer Healthcare

• Diagnostics

• Biopharma

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From leading in-house technology for micro and macro tooling/molding, white rooms and clean rooms Westfall is disrupting the medical market offering a customer-centric solution set with a single point of accountability. And we are recognized as the lowest risk medical product development supplier among all third-party manufacturers as required by ISO 13485 and FDA.

Our business philosophy of being nimble, scalable, and comprehensive allows us to be ALL IN, no matter how complex the customer’s challenge from micro to macro. Our proprietary integrated operating model optimizes the customer experience by minimizing time to market while maximizing customer lifetime value.

As a leader in the medical market we take pride in our ability to develop Innovative Plastics Solutions built around Sustaining and Saving Lives.

Westfall Technik...ALL IN

Sponsorship opportunities are available for future DeviceTalks and Robotics programs. For more information, contact Courtney Nagle. 440.523.1685 | cnagle@wtwhmedia.com

President, Digital, Robotics, and Enabling Technology Stryker

CEO, Chairman Boston Scientific CEO Moon Surgical

CEO, Chairman, President Becton Dickinson

ROBERT COHEN MIKE MAHONEY ANNE OSDOIT

TOM POLEN

Medtech conversations that inspire the next generation of devices

Able Electropolishing 37

Accumold 43

Advanced Powder Products 95 AI Drug Discovery 48 AllMotion 6 Altech Corporation 8, 9 Artery Studios 89 B. Braun BC Bay Associates Wire Technologies, Inc. 31 Biocoat 23 BMP Medical 2 Cadence 25 Canon U.S.A. Inc 38

Canon Virginia 81

Carl Stahl Sava Industries 65 Chieftek Precision 82 Cirtec Medical 30 Clippard 13 Components Corporation 28 COMSOL 67 Confluent Medical Technologies 47 Cretex 87 Eagle Stainless Tube 69 ebm-papst 1 Filmecc USA, Inc. 42

2023 MEDTECH LEADERSHIP

Able Electropolishing 108 Accumold 109 Advanced Powder Products 110 AllMotion 111 Altech Corporation 112 Artery Studios 113 B.Braun 114 Bay Associates Wire Technologies, Inc. 115 Biocoat 116 BMP Medical 117 Cadence 118 Canon U.S.A. Inc 119 Canon Virginia 120 Carl Stahl Sava Industries 121 Chieftek Precision 122 Cirtec Medical 123 Clippard 124 Components Corporation 125

COMSOL 126 Confluent Medical Technologies 127 Cretex 128 Digi International 129 Eagle Stainless Tube 130 ElectroCraft, Inc. 131

LEADERSHIP

TEAM

Managing Director

Scott McCafferty smccafferty@wtwhmedia.com 310.279.3844 @SMMcCafferty

EVP

Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

VP of Sales

Flexan 33

Freudenberg Medical 97 Galt - Needletech 68

Halkey | Roberts 29 Hobson & Motzer 3 HP 3D Printing 27 Integer 62 Interpower 101 Isometric Micro Molding 53 J.W. Winco, Inc. 32 John Evans’ Sons, Inc. 60 Johnson Matthey 41 Kahle Automation 17 Keystone Electronics Corp 5 KNF Neuberger 57 Laird Connectivity 105 Lee Spring Company 75 LEMO USA 61 Master Bond 63 maxon 76 Medbio Inc 66 MICRO Medical 51 MicroLumen 72, 73 Ming Tai Industrial Co., Ltd. 44 Misumi 106

FAULHABER 132

Filmecc USA, Inc, subsidiary of Asahi Intecc USA. 133 Flexan 134 Freudenberg Medical 135 Galt - Needletech 136 Halkey | Roberts 137 Hobson & Motzer 138 HP 3D Printing 139 Integer 140 Interpower 141 Isometric Micro Molding 142 J.W. Winco, Inc. 143 Johnson Matthey 144 Kahle Automation 145 Keystone Electronics Corp. 146 KNF Neuberger 147 Laird Connectivity 148 Lee Spring Company 149 LEMO USA, Inc. 150 Master Bond 151 maxon 152 Medbio, Inc. 153 MICRO (Micro Medical) 154 MicroLumen 155 Ming Tai Industrial Co., Ltd. 156

SALES

Mike Emich memich@wtwhmedia.com 508.446.1823 @wtwh_memich

Ryan Ashdown 216.316.6691 rashdown@wtwhmedia.com

Jami Brownlee 224.760.1055 jbrownlee@wtwhmedia.com

Ashley N. Burk 737.615.8452 aburk@wtwhmedia.com

Nelson Labs 91

New England Wire & Tubing Technologies 71

Nitto Kohki U.S.A. Inc. 45 OKW Enclosures, Inc. 21 P-DUKE Technology Co., Ltd. 93 Performance Motion Devices 55 PSN Labs 59

PTI Engineered Plastics 103 Qosina 39 Resonetics IFC Rohm GmbH 7 Rotor Clip 19 SCHURTER Inc 24

SENKO Advanced Components 16 SigmaTron 85 Solar Atmospheres 36 Sorbothane 20 Steute Meditech, Inc. 11 Stock Drive Products/Sterling Instrument 15 Tegra Medical IBC

The Mediashop 49 Trelleborg 99 Viant Medical 50 Westfall Technik 35

Misumi USA 157 Nelson Laboratories 158 New England Tubing Technologies 159 New England Wire Technologies 160 Nitto Kohki U.S.A. Inc. 161 OKW Enclosures, Inc. 162 Omron Automation Americas 163 P-DUKE Technology Co., Ltd. 164 Performance Motion Devices/PMD 165 PSN Labs 166 PTC 167

PTI Engineered Plastics 168 Qosina 169 Resonetics 170 Rotor Clip 171

SCHURTER Inc 172 SDP/SI-Stock Drive Product 173 SigmaTron 174 Solar Atmospheres 175 Sorbothane 176

STEUTE Meditech Inc. 177 Tegra Medical 178 The MediaShop 179 Trelleborg Healthcare 180 Viant Medical 181 Westfall Technik 182

Mary Ann Cooke 781.710.4659 mcooke@wtwhmedia.com

Jim Dempsey 216.387.1916 jdempsey@wtwhmedia.com

Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029

Courtney Nagle cnagle@wtwhmedia.com 440.523.1685

Jim Powers jpowers@wtwhmedia.com 312.925.7793 @jpowers_media

Brian Toole 267.290.2386 btoole@wtwhmedia.com

It starts with decades of product development expertise. Our vast catalog of standard components can be customized to generate endless possibilities for sets and kits. We put in place processes for ensuring stringent quality levels, managing volumes of documentation and tracking all project details. Add in a full suite of capabilities, and you have a turnkey solution that’s more like a partnership for creating confidence.