Medical Design & Outsourcing – JULY 2024

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HOW VIRTUAL INCISION DESIGNED THE SMALL BUT MIGHTY MIRA SURGICAL ROBOT — AND THEN SHRANK IT AGAIN FOR SPACE

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HOW VIRTUAL INCISION DESIGNED THE SMALL BUT MIGHTY MIRA SURGICAL ROBOT — AND THEN SHRANK IT AGAIN FOR SPACE

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NEW!

HERE’S WHAT WE SEE

4 AXIS SERVO

Medtech suppliers make it happen — on Earth and in space

from

V

2.25”

irtual Incision’s test of its surgical robotics system in space took some serious collaboration with third-party partners.

NASA and SpaceX got the device into orbit aboard the International Space Station. But it was work with Maxon on miniature motors that helped Virtual Incision achieve the compact design of its MIRA (Miniaturized In Vivo Robotic Assistant) Surgical System as well as the smaller SpaceMIRA version.

This issue of Medical Design & Outsourcing focuses on supplier innovations and devices enabled by those medtech partners. That includes our Virtual Incision cover story and our feature on Orthobond, the developer of a new antimicrobial coating that has won FDA de novo approvals for other device developers’ implants. We also highlight medtech suppliers with our new DeviceTalks Spotlight interviews, some of which we’ve excerpted in this issue.

You’ll notice the first appearance of our Nitinol department, this month featuring a thin-film contract manufacturer that’s partially owned by braincomputer-interface startup Synchron. With device developers and suppliers continuing to find new and innovative applications for nitinol, we’ll use this department to keep you up to date on the latest advances.

This issue includes design tips for connectivity from Eko Health co-founder and CEO Connor Landgraf. His startup has developed noninvasive, AI-powered medical devices that are FDA-cleared to help physicians detect heart conditions.

And this issue has more than suppliers and startups. Executive Editor Chris Newmarker interviews Abbott’s director of R&D for electrophysiology catheters to learn how his team developed the next-gen TactiFlex catheter for radiofrequency ablation.

Newmarker also compiled his annual ranking of the world’s largest orthopedic device companies ahead of the Medtech Big 100 ranking of all device companies that we’ll publish in September. (Speaking of our Medtech Big 100 list, make sure to get your applications in at wtwh.me/big100app soon.)

Associate Editor Sean Whooley reports on how Tandem Diabetes Care’s latest device, the Mobi insulin pump, leans into two leading diabetes technology trends: miniaturization and automation.

But before you dive into this edition, I have a request. Please take a look at our MDO Tech Trends survey at wtwh.me/mdotechtrends and answer as many or as few questions as you’d like. This survey will help us call attention to device developers, manufacturers, suppliers and other partners who are doing their part every day to bring new and improved products to physicians and patients. Feel free to share with your colleagues — we welcome multiple submissions for a single organization — as well as your external partners and anyone else in your network who you think would appreciate sharing the work they do.

As always, I hope you enjoy this edition of Medical Design & Outsourcing — and thanks for reading.

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7 • 2024

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July 2024 • Vol.10 No.4 • medicaldesignandoutsourcing.com

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Medical Design & Outsourcing

7 • 2024

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CONTENTS

medicaldesignandoutsourcing.com • July 2024 • Vol. 10 No. 4

DEPARTMENTS 01

HERE’S WHAT WE SEE:

Medtech suppliers make it happen — on Earth and in space

09 NITINOL:

Thin-film device manufacturer Acquandas does more than brain implants

11

26

ON THE COVER

ORTHOPEDICS:

MINIATURE IS BIG

The 10 largest orthopedic device companies in the world

15

PRODUCT DESIGN & DEVELOPMENT:

19

TUBING:

23

CONNECTIVITY:

How Virtual Incision designed the small but mighty MIRA surgical robot — and then shrank it again for space

How Abbott created its nextgen RF ablation system

30

Engineered silicone swelling fluids enhance medical device design and manufacturing

35

Wireless connectivity design tips from AI-powered device developer Eko Health

30 TANDEM DIABETES CARE TAPS MINIATURIZATION AND

AUTOMATION FOR ITS LATEST SYSTEMS

38 DEVICETALKS:

Tandem Diabetes Care EVP and Chief Strategy Officer Elizabeth Gasser didn’t exactly plan for the whirlwind past year or so.

See the future of medtech with DeviceTalks Spotlights

40 AD INDEX

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Medical Design & Outsourcing

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FEATURES

HOW ORTHOBOND’S ANTIMICROBIAL COATING PREVENTS CONTAMINATION OF MEDICAL DEVICES

A new antimicrobial coating could go a long way in keeping medical devices free of infection-causing microbes.

7 • 2024

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When you give your customers what they need, they’ll need you even more Steute is unrivaled in its ability to customize foot switches to specific customer requirements The needs of medical professionals (and the patients they treat) are changing as rapidly as the environments in which they work. No other foot switch supplier can match Steute’s ability to customize products to provide the best solutions when they are needed most.

All Steute foot switches are medical-grade and offer such custom options (with no tooling or NRE) as: • Actuator styles • Console color and finish • Consoles/platforms • Wiring configuration • IP-rating • Selectable actuating forces • Connector styles • Strain reliefs • Handles/foot rests • Graphics • Cable type/colors …and many more

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NITINOL

This nitinol thin film actuator made by Acquandas with a film thickness of 50 µm can pull 550 times its own weight.

Image courtesy of Acquandas

Thin-film device manufacturer Acquandas does more than brain implants Acquandas founder Rodrigo Lima de Miranda discusses microsystem technology and potential applications.

A

Jim Hammerand Managing Editor

cquandas is a thin-film device manufacturer that’s now partially owned by brain-computer interface developer Synchron.

Rodrigo Lima de Miranda founded Acquandas in 2012 based on microsystem technology he developed for his doctoral thesis, where he was trying to develop a shape memory material made with thin-film deposition.

The Kiel, Germany-based contract manufacturer now uses the Nanolab cleanroom facilities at Kiel University and is growing its team of around 22 employees.

Beyond neurotech applications like Synchron’s Stentrode, the Acquandas technology has promising potential for cardiac ablation, renal denervation, ophthalmology, nerve stimulation, passive microimplants, microneedles, and smart actuators and springs, Lima de Miranda said in an interview with Medical Design & Outsourcing.

The Acquandas microsystem technology utilizes a vacuum environment with UV lithography and magnetron sputter deposition (a type of physical vapor deposition) to create and fabricate devices. It’s the same technology used for MEMS (micro-electromechanical systems) manufacturing. www.medicaldesignandoutsourcing.com

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Acquandas additive manufacturing uses nitinol, titanium and alloys of magnesium and iron as base materials for varying properties such as mechanical stability, flexibility, crimpability, self-expansion (for a catheter-delivered implant, for example) or bioabsorbability. Then Acquandas can layer on or structure other elements and compounds like gold or silicon oxide to act as electrodes, isolators, temperature sensors or magnetics.

Biocompatible polymer materials can also be added to such material systems.

Lima de Miranda said benefits of the microsystem technology include miniaturization, design freedom, superior mechanical properties, increased radiopacity, cost efficiency, additional functionality, rapid prototypying, microstructured surfaces, excellent biocompatibility and simple alloy engineering.

“With our technology, because we are coming from the gas phase we don’t have inclusions in the material, thus great mechanical properties, plus an immense design freedom since each layer can be dimensionally and functionally tailored for a desired application,” he said.

When dealing with miniaturized devices, the company’s manufacturing equipment in one case was able to fit 30,000 devices on a single, 6-in. production wafer, though the company works with larger wafers when needed.

In the decade-plus since founding Acquandas, Lima de Miranda has worked on research and experimentation to develop the technology for mass production while building its client list to more than 50.

“This deal with Synchron shows that we are ready for the market,” he said.

7 • 2024

Medical Design & Outsourcing

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DePuy Synthes — the Johnson & Johnson MedTech business that makes the Velys orthopedic system depicted here — took the top spot in our ranking of the largest ortho device companies.

Image courtesy of Johnson & Johnson MedTech

The 10 largest orthopedic device companies in the world Our list of the largest orthopedic device companies has changed a lot since last year.

A

Chris Newmarker Editor in Chief

change in methodology means there is a new company at the top of this year’s MassDevice and Medical Design & Outsourcing ranking of the world’s largest orthopedic device companies. But mergers and spinoffs also added to the list two orthopedic developers and manufacturers that weren’t ranked last year.

From endoscopic devices to brain surgery tech to emergency defibrillators, Stryker is so much more than an orthopedic device company. Our editors decided it was time to break out the company’s Orthopaedics and Spine business going forward. The move means that we now consider Johnson & Johnson MedTech’s DePuy Synthes business the world’s largest orthopedic device company, but just by a hair.

Stryker could be back on top next year. DePuy Synthes’ revenue growth accelerated to 4.4% in 2023, but Stryker’s ortho and spine business grew at an even faster rate of 10.5%.

In fact, many of the companies on the largest orthopedic device companies list saw revenue growth pick www.medicaldesignandoutsourcing.com

Orthopedics_7-24_Vs6-CN-FINAL.indd 11

up in 2023 as the industry returned to pre-pandemic growth levels.

Stryker has especially enjoyed success on the popularity of its Mako surgical robotic systems for knee and hip surgeries. Last year, the Mako systems passed the 1 million procedure mark globally. Expect Mako’s growth to speed up even more, with shoulder and spine applications planned for later in 2024.

Mako’s success means that many of Stryker’s competitors have also become more active in robotic and digital surgery.

Johnson & Johnson’s DePuy Synthes recently secured FDA clearance for the use of its Velys surgical robot platform in unicompartmental knee arthroplasty. The FDA previously cleared Velys for total knee arthroplasty (TKA) in early 2021.

Meanwhile, Zimmer Biomet recently agreed to distribute Think Surgical’s TMINI miniature robotic system for TKA, a move that provides a handheld robotic option on top of ZB’s flagship Rosa surgical robotics portfolio.

And Smith+Nephew now has its CorioGraph pre-operative planning and modeling services for its Cori system. >> 7 • 2024

Medical Design & Outsourcing

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ORTHOPEDICS

LARGEST ORTHOPEDIC DEVICE COMPANIES

ANNUAL REVENUE (% CHANGE)

HEADQUARTERS OR SIGNIFICANT LOCATIONS

1

Johnson & Johnson (DePuy Synthes)

$8.9B (+4.4%)

Locations: Raynham, Massachusetts.; West Chester, Pennsylvania; Warsaw, Indiana; Palm Beach Gardens, Florida

2

Stryker (Orthopaedics and Spine)

$8.7B (+10.5%)

HQ: Kalamazoo, Michigan

3

Zimmer Biomet

$7.4B (+6.5%)

HQ: Warsaw, Indiana

4

Medtronic (Cranial & Spinal Technologies)

$4.8B (+6.9%)

Locations: Memphis, Tennessee; Louisville, Colorado

RANK

5

Smith+Nephew (Orthopaedics and Sports Medicine)

$3.7B (+5.6%)

In addition to robotic surgery, consolidation left its mark on our largest orthopedic device companies list.

NuVasive is now part of Globus Medical, and SeaSpine is part of Orthofix.

Meanwhile, Alphatec’s 37% revenue growth in 2023 launched it ahead of ZimVie’s spine tech business, which ZimVie sold in April for $375 million to H.I.G. Capital. (The former ZimVie spine business is now called Highridge Medical.)

Here (on the left) are the world’s 10 largest orthopedic device companies, ranked by ortho business revenue pulled from their most recent annual reports.

HQ: London

The Velys surgical robotics system from Johnson & Johnson MedTech’s DePuy Synthes has been used in more than 55,000 knee procedures.

Image courtesy of Johnson & Johnson MedTech

6

Enovis

$1.7B (+9.2%)

HQ: Wilmington, Delaware

7

Globus Medical (merged with NuVasive)

$1.6B *

HQ: Audubon, Pennsylvania

8

Orthofix (merged with SeaSpine)

$747M (+6.9%)

HQ: Lewisville, Texas

9

Conmed (Orthopedic Surgery)

$533M (+15.5%)

HQ: Largo, Florida

10

Alphatec

$482M (+37%)

HQ: Carlsbad, California

* Revenue growth is unclear in Globus Medical’s annual report.

12

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7 • 2024

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PRODUCT DESIGN & DEVELOPMENT

How Abbott created its next-gen RF ablation system For Abbott, combining two innovations into one AFibtreating system required manufacturing fine-tuning.

The project’s R&D director explains.

Abbott’s TactiFlex ablation catheter Image courtesy of Abbott

Chris Newmarker Editor in Chief

P

ulsed field ablation (PFA) has generated a great deal of buzz for its potential to reduce complications in procedures for treating atrial fibrillation (AFib). But even as Abbott is developing its Volt PFA system — announcing in January that it kicked off a CE mark clinical trial of Volt — the medtech giant is betting that tried-and-true radiofrequency (RF) ablation can still make a big difference with the right innovations.

Abbott last year won FDA approval for its next-gen TactiFlex Ablation Catheter, Sensor Enabled. The company described it as the world’s first ablation catheter with a flexible tip and contact force technology.

“Launching TactiFlex — which is the flexible tip combined with the contact force — we’ve seen great results, great outcomes, whether it’s outcomes for the patient or time of procedure. We’ve seen that consistently around the world,” Abbott CEO Robert Ford said during the company’s fourth-quarter earnings call in January. www.medicaldesignandoutsourcing.com

ProductDesign_7-24_Vs3-CN-FINAL.indd 15

Erich Stoermer became director of R&D for electrophysiology (EP) catheters at Abbott in mid-2019, about a year after formal TactiFlex product development started. During an interview late last year with Medical Design & Outsourcing, he explained how the company already had contact force sensing in its TactiCath Sensor Enabled ablation catheter and a flexible tip in its FlexAbility Sensor Enabled catheter.

Each had benefits. Contact force sensing enables electrophysiologists to ensure the tip has the appropriate force (measured in grams) against the cardiac tissue being ablated.

Meanwhile, the flexible tip provided better maneuverability, more grip against the tissue because of its latticelike structure, and more efficient saline irrigation at the ablation site.

“Physician feedback was, ‘We think it’d be really powerful from a safety and effectiveness standpoint to really combine these technologies into one catheter,’” Stoermer said. >> 7 • 2024

Medical Design & Outsourcing

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PRODUCT DESIGN & DEVELOPMENT

Abbott Director of R&D for EP Catheters Erich Stoermer

Integrated with 3D heart modeling and electrical mapping from Abbott’s EnSite X EP system, the next-gen system could reduce procedure times and boost safety compared with previous generations of RF ablation tech.

A top challenge to get there involved fine-tuning and tighter tolerances in the manufacturing process.

“Anything that goes into this is in the millimeter or sub-millimeter range/ tolerance. … There are parts of our manufacturing process where we’re controlling things to the nanometer,” Stoermer said.

The reason why the force-sensing/ flexible-tip combination required tighter tolerances became apparent as Stoermer described how the tri-axial optical force sensor system in TactiFlex works.

He gestured to a diagram of the system outside the Minneapolis-area cleanroom where workers in cleanroom garb were assembling the TactiFlex system under microscopes: “You can see the tip electrode being fixtured, and it’s been set very carefully into the distal end of the catheter. …

Those three shaft electrodes we talked about at the distal end of the catheter [for ECG readings], those are being brought up, and then we bond the shaft to the tip electrode. You can see this is what we call the deformable body, so as forces are applied to the tip, the force is transmitted.

This … body deforms, and it deforms by nanometers. You’ve got three fiber optics being set into a deformable body.

Those three optical fibers are reflecting light, back and forth. And then as forces are applied, the reflection of that light is transmitted differently. That’s what tells the computer how much force is being applied in one direction. And that goes into our TactiSys box, which then tells 16

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Medical Design & Outsourcing

6/26/24 8:24 AM

Abbott Electrophysiology Chief Medical Officer Dr. Christopher Piorkowski

EnSite how much force is being applied to the catheter. So this is the heart of the force sensing technology right here.”

The handle — which has some new design features to let a surgeon maneuver the catheter without having to look down from the EnSite screen — gets assembled on the proximal end. Electrical wires, shaft deflection wires, thermocouple wires, fiber

optics and the irrigation lumen all route back from the tip through the catheter’s 8 Fr distal section and 7.5 Fr shaft with steel braiding and a polymer jacket.

Stoermer declined to go into much detail about what kind of tweaking was needed to ensure the sensing system worked with a flexible tip, citing proprietary information. But he said getting the design and manufacturing process right involved computer modeling of how the contact force sensing system and flexible tip would work together in RF ablation procedures, and then experiment-based adjustments.

“It took some fine-tuning of our design and manufacturing process controls to ensure that we got the same level of consistency and accuracy as we had on the TactiCath,” he said.

Tighter tolerances were crucial for the undisclosed contract manufacturer that laser cuts the TactiFlex’s platinum iridium flexible tip.

“It’s largely automated, and that really takes care of providing a consistent high-quality component. …

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The result is a next-gen RF ablation system with combined stability and safety to improve physician experience and patient outcomes, according to Dr. Christopher Piorkowski, chief medical officer and divisional VP of medical affairs for Abbott’s electrophysiology business.

“TactiFlex provides double the amount of stability at the moving heart wall, which can give physicians more peace of mind to make a good lesion in the moving heart of a breathing patient,” Piorkowski said. “The stability of the catheter plus the confidence in the position of the ablation work together to shorten the procedure time, reducing the risk of complications.”

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TUBING

Engineered silicone swelling fluids enhance medical device design and manufacturing Engineered silicone swelling fluid offers an innovative solution to the challenges of integrating complex multi-lumen tubing into modern medical devices.

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Elizabeth Norwood MicroCare

s medical devices become smaller and more functionally complex, seamless integration of precision components is critical.

Designers must maximize portability and usability, while manufacturers need efficient assembly methods that meet stringent quality standards and productivity goals. Establishing this vital link between ambitious design and streamlined manufacturing is essential.

There are significant obstacles in the incorporation of advanced tubing components into modern medical devices. While offering immense potential for enabling new device capabilities, these advanced tubing designs present unique integration challenges.

Engineered silicone swelling fluids are an innovative solution to overcome these hurdles. By easing the assembly of compact, intricate tubing, swelling fluids allow designers to push design boundaries while enhancing manufacturing outputs and enabling successful outsourcing partnerships. www.medicaldesignandoutsourcing.com

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Manufacturers can outsource production of complex tube fitting assemblies to specialized suppliers who use engineered swelling fluids to boost throughput, as design intricacy is no longer a limiting factor.

Photo courtesy of MicroCare

Design challenges in modern medical devices Many of today’s medical devices — ranging from IV tubes and bags to drainage catheters and dialysis machines — rely on tubing that must meet stringent tolerances in inner/ outer diameter and wall thickness.

These devices often need intricate multi-lumen tube construction, featuring multiple channels within a single tube for the delivery of fluids, gases, guidewires or miniature cameras. As demand for nextgeneration medical technologies continues to rise, the complexity of these tubing designs presents significant challenges in assembly. >> 7 • 2024

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TUBING

Many medical devices rely on tubing that provides reliable, leak-proof connections to device fittings and components.

Photo courtesy of MicroCare

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The precise manufacturing needed for these advanced tubing designs means making reliable, leakproof connections to device fittings and components is paramount. However, this task becomes increasingly difficult due to the delicate nature of the tubing and the need to accommodate diverse functionalities within a single conduit.

Silicone is still the preferred elastomer for medical tubing due to its biocompatibility, durability and flexibility. But unlike some materials, silicone does not naturally expand or stretch over connector barbs and textured surfaces, needing careful handling during assembly. Furthermore, silicone exhibits a high coefficient of friction, which can impede smooth assembly processes.

The delicate nature of these advanced thin-wall and multi-lumen tubes means that physically forcing them onto rigid fittings risks material damage, stress cracks and assembly failure. Such issues compromise the integrity and performance of the medical device and pose potential risks to patient safety.

To address these challenges, manufacturers must employ innovative solutions that ensure seamless assembly while keeping the integrity of the tubing and the overall device. This may involve the development of specialized connectors, lubricants or assembly techniques tailored to the unique properties of silicone and the specific requirements of advanced medical tubing.

Swelling fluids explained Swelling fluids offer a practical solution by temporarily enlarging tubing diameters, allowing tubes to easily slide over connectors with complex geometries before returning to their original dimensions for a tight, secure fit.

Three primary swelling fluids are commonly used in the medical device industry: 20

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1. Silicone oils: Silicone oils function as effective lubricants, easing tubing assembly. However, they can be messy, potentially transferring residues to equipment and surfaces and attracting contaminants.

Furthermore, medical grade silicone oils are expensive and offer limited swelling capabilities, making them less suitable for complex shapes and delicate tubing.

2. Isopropyl alcohol (IPA): As a costeffective solvent, IPA swells tubing, aiding assembly. However, its slow drying time prolongs assembly cycles, affecting productivity.

Additionally, IPA may not provide sufficient expansion for fragile, thinwalled tubes, leading to potential collapse or folding during assembly.

3. Engineered silicone swelling fluids: These formulations are specifically engineered to maximize and control uniform tubing expansion through short-term immersion before allowing the tubing to fully recover to its original dimensions. This temporary swelling action enables precise fitting over connectors with intricate geometries.

The engineered solution: silicone swelling fluids While silicone oils and IPA have been widely used to aid in tubing assembly, their limitations can negatively impact productivity and design execution when manufacturing advanced medical devices.

These traditional fluids struggle to provide sufficient, uniform expansion for fragile multi-lumen tubing that must conform to detailed, intricate connector geometries, limiting design possibilities.

Silicone swelling fluids, however, are specifically engineered to maximize design flexibility and streamline manufacturing processes.

One end of the silicone tube is immersed in the fluid, allowing the walls to swell and expand in a controlled, predictable manner. Often, just 1-2% expansion is needed for assembly. The exposure or soaking time determines the amount of swelling, enabling precise control over the expansion.

After the expanded tube slides over the fitting, the swelling fluid quickly evaporates, allowing the tube to return to its original molded size, resolute durometer, compression set, and strength, creating a tight, locked connection regardless of the connector’s geometric complexity.

This temporary swelling action does not degrade, weld or change the tubing material’s chemical composition or physical properties. It enables assemblies to be nonpermanent, easing field serviceability and modular designs. Manufacturers can outsource production of complex tube fitting assemblies to specialized suppliers who use engineered swelling fluids to boost throughput, as design intricacy is no longer a limiting factor.

Engineered silicone swelling fluids temporarily enlarge tubing diameters, allowing them to easily slide over connectors before returning to their original dimensions for a tight, secure fit.

Photo courtesy of MicroCare

www.medicaldesignandoutsourcing.com

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Compliance, sustainability and operational efficiency Unlike hazardous solutions like hexane and toluene which were commonly used as swelling fluids, engineered silicone swelling fluids are sustainable, environmentally friendly formulations that meet stringent medical and quality standards: • • • • •

Biocompatible and safe for use in medical device manufacturing Low global warming potential (GWP) Zero ozone depletion potential (ODP) Not classified as hazardous air pollutants (HAPs) Do not produce residues that impact cleanroom validation processes

Their excellent materials compatibility prevents damage to tubing, inks/ coatings, connectors, and finished devices, reducing scrap rates and associated costs.

Furthermore, engineered swelling fluids enhance operational efficiency by reducing the force required for assembly, minimizing the risk of workplace injuries caused by repetitive strain. This ergonomic benefit contributes to a safer working environment and increased productivity.

Driving innovation through outsourcing in medical design Outsourcing complex assemblies to specialized suppliers that use swelling fluids not only grants OEMs access to expertise and the latest advancements, but also offers potential cost savings and efficiency improvements.

Swelling fluids facilitate greater design creativity, supporting advanced medical solutions that meet the evolving needs of patients and healthcare providers. By adopting swelling fluid technology, device developers can gain a competitive edge, fostering collaboration, agility and cost-effective innovation.

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

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Eko Health’s algorithms use acoustic and ECG data collected by digital stethoscopes (pictured is Eko’s Duo stethoscope).

Photo courtesy of Eko Health

Wireless connectivity design tips from AI-powered device developer Eko Health Eko Health co-founder and CEO Connor Landgraf offers lessons learned on Bluetooth, batteries and Apple versus Android.

Jim Hammerand Managing Editor

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Eko Health cofounder and CEO Connor Landgraf

ko Health has learned a bit about batteries and Bluetooth while developing AI-powered medical devices to help physicians detect cardiovascular disease.

Eko Health’s devices include hardware — in the form of its Duo and Core digital stethoscopes — and algorithms that analyze the acoustic and electrocardiogram (ECG) signals collected by those handheld devices. Together, their hardware and software is cleared by the FDA to detect heart murmurs, atrial fibrillation (AFib) and signs of low left ventricular ejection fraction.

In an interview with Medical Design & Outsourcing, Eko Health co-founder and CEO Connor Landgraf said Bluetooth and battery advances deserve some of the credit for making the device developer’s products possible. He shared a few of Eko Health’s lessons with www.medicaldesignandoutsourcing.com

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those technologies — including considerations when choosing between Apple iOS and Android platforms — as well as general advice for medical device designers and engineers.

Bluetooth design tips “Surprisingly, we’ve actually been able to work pretty well inside the bounds of Bluetooth,” he said. “Part of that was writing a custom protocol and going down to very low level in terms of the actual design of the control of the Bluetooth protocol and firmware, and being able to do a lot of work around data compression in a lossless fashion, signal processing above that to ensure that we are really honed in on the frequency that we cared about, and then optimizing for error checking and the appropriate assessment to make sure that there was no data loss or data corruption in transit.” >> 7 • 2024

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CONNECTIVITY

“We basically wrote a protocol specifically for the data type that we were trying to transfer, and as a result, we have been really happy with the durability and reliability of these connections,” he continued. “We’re not talking 30, 40 feet here. We’re talking 5 feet in the exam room. It’s worked quite well for us and we’re really happy with it.”

He had words of caution for device designers and engineers tempted to start from scratch.

“At least in our situation, we’ve definitely seen plenty of other companies choosing to write stuff from the ground up and choosing their own customized protocol and not relying on Bluetooth, but using some modified version of a different 2.4 GHz protocol or something like that,” he said. “Operating inside the constraints of a very well accepted and well tested platform like Bluetooth but then doing a lot of customization to get the exact type

of data and the exact type of packet structure and the appropriate checksums and such worked really well for us. We got all the structure and stability of a really well tested code base like Bluetooth that was supported by a lot of different vendors and different chipsets, and got the customizability that we wanted to be able to make it work on our specific structure.”

Apple iOS vs. Android One of the biggest considerations when working with Bluetooth is the variable quality of receivers, which might influence a device developer’s choice on whether to support Apple’s iOS versus Android platforms.

Eko Health’s Core 5000 digital stethoscope has a rechargeable lithiumion battery that lasts up to 300 minutes of continuous use, or up to 60 hours of regular clinical use. The stethoscope uses Bluetooth 4.2 low-energy and offers a wireless listening option.

Photo courtesy of Eko Health

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6/26/24 8:38 AM

“In the Android ecosystem you have a huge number of Bluetooth chipsets from a huge number of manufacturers with highly variable quality between them. That creates a testing challenge as well as a neverending list of possible handsets or tablets that customers might be using. You’d have to kind of narrow it down to the ones you’re going to support and the rest are not necessarily going to be officially supported,” he said. “A constrained set of compute environments that you’re going to support on the mobile side for us was pretty important. We ran into problems otherwise. In our situation, we found the iOS support for Bluetooth and just the quality of the chipset is quite a bit better and it’s a much smaller set of vendors and chipsets to deal with, therefore a more constrained problem to solve.”

“The big chip guys, the big vendors in Android are great,” he continued. “The ones that make up 80% of the market are fantastic. But that last 20%, it’s just absolutely staggering how many vendors you’ve never heard of are making different random phones. The quality of the hardware falls off pretty fast and it’s just not solvable in those situations.”

Battery tips for handheld medical devices On the portable power side, Landgraf said there’s “nothing particularly revolutionary” about the rechargable batteries Eko uses, but he offered some general tips for mobile device developers.

“We ended up choosing pretty standardized battery structure and battery chemistry — off-the-shelf lithiumion for the most part — with a lot of rigorous validation of the batteries to ensure that they’re high quality,” he said.

“With any sort of med device battery,

there’s a good bit of variability in the quality of vendors on the battery side, so pick a vendor that has the certifications that you want on the cells and has the appropriate rigor and just overall quality to be able to support consistency and and save batteries. That’s a big priority.”

“Many times with small batteries, you run into problems when you try to squeeze very high volumes or very high capacities into a small space,” he continued. “If you can relax those constraints and use a slightly less dense battery, not trying to optimize capacity quite as much, you just find that durability and reliability in the batteries improves a lot. But when you try to cram in large number of cells or larger capacity into a very small face, it creates more problems for many of those battery manufacturers who are trying to squeeze the narrowest area between connectors and stuff like that.”

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NASA astronaut and Expedition 70 Flight Engineer Loral O’Hara poses with Virtual Incision’s spaceMIRA aboard the International Space Station.

Photo courtesy of NASA

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6/26/24 12:40 AM

VIRTUAL INCISION

THE VIRTUAL INCISION MIRA SURGICAL SYSTEM’S DESIGN WAS SMALL TO START WITH — AND THEN CAME AN OPPORTUNITY TO TEST ABOARD THE INTERNATIONAL SPACE STATION.

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How Virtual Incision designed the small but mighty MIRA surgical robot — and then shrank it again for Space JIM HAMMERAND MANAGING EDITOR

n conversations with Medical Design & Outsourcing, surgical robotics developers often say they try to use as many off-the-shelf components as possible.

That wasn’t possible for the MIRA (Miniaturized In Vivo Robotic Assistant) Surgical System, Virtual Incision cofounder and Chief Technology Officer Shane Farritor said.

“Everything in our device is quite custom … from scratch, bespoke,” he said in an interview. “… Our robot’s different than everyone else because it’s miniature, and we think miniature is big.”

Virtual Incision’s MIRA won FDA de novo classification in February 2024 as a table-mounted miniaturized electromechanical surgical system.

At the same time, a modified version called spaceMIRA was in orbit aboard the International Space Station for a mission to test how well surgeons on Earth could control the robot.

“The story starts with the University of Nebraska Medical Center,” Farritor said. “I was on faculty at the engineering college, but the medical center acquired the eighth da Vinci ever sold. They were very early adopters of robotic surgery and they hired my co-founder, Dr. Dmitry Oleynikov, to start a robotic surgery program. And this is 2002, 2003 — really, really early. He and I both thought that there’d be another way to do surgery, that it should be small robots that go inside the body rather than big robots reaching in from the outside. Da Vinci is an incredible machine, maybe the best medical device ever made. But we think there’s also an advantage to small devices. So we started making little robots.” >>

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In the beginning, those robots looked like miniature versions of the rovers NASA sent to Mars. Before joining the University of Nebraska, Farritor worked on the Mars Rover project through Massachusetts Institute of Technology’s Field and Space Robotics Laboratory and the C.S. Draper Laboratories Unmanned Vehicle Lab. Virtual Incision’s research won funding from the U.S. government “because NASA and the Army want to do surgery in crazy places, and miniature devices lend themselves to crazy places,” Farritor said.

Virtual Incision is designing more devices for soft-tissue, abdominal procedures.

“We think every surgical procedure can be addressed with a miniature robot,” Farritor said.

Designing a miniature surgical robot “Most of the other devices are big robots on the outside,” Farritor said.

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“That means you put big motors on the outside, and then you have usually cable transmission into the body to actuate the tips of the instruments. That has a lot of advantages, but you have a bigger motor and then you have to have a bigger motor to hold that motor and it snowballs into a big device.”

So Virtual incision designed MIRA with local actuators, placing miniaturized Maxon motors closer to where the robot’s instruments would actually be working.

“Mechanically, our robots are pretty tightly packed and that can cause all kinds of other problems, but we think it has all sorts of advantages to the challenges we think we’ve overcome,” he said. “You can’t have big motors, you have to use little motors efficiently. Efficiency is a big issue, heat dissipation, all these sorts of things start to come into play. But we think MIRA is a fantastic device and shows the feasibility of this approach.”

One advantage is the ability to quickly move from quadrant to quadrant within a patient.

“To go from the rectum all the way up to the spleen, over to the liver, and then down to your cecum happens in seconds with our device,” he said. “There’s no docking, there’s no undocking, there’s no instrument change required. Multiquadrant access is one of the powerful aspects of miniature.”

Another advantage of miniaturization is constant triangulation. Instead of a multiport system that inserts instruments from several incisions and comes together inside the patient, the MIRA system is internally triangulated when it drops in.

“It’s really inherent with the design of the device and it’s, again, part of being miniature. The surgeon always gets the same first-person view, like we’ve shrunk them down and put them inside the body,” he said.

www.medicaldesignandoutsourcing.com

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VIRTUAL INCISION

For simplicity and ease of use, Virtual Incision designed the MIRA system with a single cable and to use only four disposables — and no drapes. The system can be set up in six to eight minutes.

“Our focus has always been on simplicity in the operating room, and that’s been the driving ethos in the work that we do. We want to make our system easy to use so that you don’t need special teams to be trained and you can do surgery in forward environments, you can do surgery at night. All these things that make it simpler, we think also makes it more useful. One of the effects of simplicity can be low cost.”

MIRA is also designed for up to 15 cycles of reuse with vaporized hydrogen peroxide (VHP) sterilization. Ethylene oxide is difficult to work with and the surgical robot can’t be sterilized with an autoclave, so VHP is “the next-simplest” method of sterilization, Farritor said.

“It made sense for us,” he said.

“It’s another step toward simplicity and sustainability.”

The Virtual Incision MIRA Surgical System’s arm weighs around 2 lbs.

Photo courtesy of Virtual Incision

Making MIRA even smaller for space Virtual Incision modified MIRA into an even more compact spaceMIRA to fit inside a NASA-provided locker aboard the International Space Station. Those microwave-size lockers fit in EXPRESS Racks, short for “expedite the processing of experiments to space station.” Those racks have connections for power, data and video, plus cooling, water, nitrogen supply and vacuum exhaust.

To fit into one of those lockers, SpaceMIRA is about three inches shorter than its Earth-bound predecessor.

“MIRA has a long straight section that will accommodate different abdominal wall thicknesses and different surgical targets inside the body so you can extend to different targets. We didn’t need to do all that in our experiment, so we were able to shorten it and fit it in the diagonal of that EXPRESS Rack locker,” Farritor said.

“NASA does a lot of these lockers and they know how to handle them, so that really simplified our in-flight operations.”

Virtual Incision conducted two experiments aboard the ISS. The first was a pre-programmed run for semiautonomous surgery, testing how well the surgical robot could cut rubber bands on its own as a simulation of surgical tasks.

The second experiment was to test and demonstrate telesurgery, giving surgeons on the ground control of the robot as it orbited 250 miles above Earth.

They performed simple and advanced tasks despite 600-800 ms of latency.

“They learn to deal with the delay.

This was only simulated surgery, but I was really encouraged that they were all able to do the task,” Farritor said.

“It’s preliminary, but they all moved very deliberately, so the total distance traveled was actually less than when they would do these procedures on Earth. … It really just confirms and encourages a lot of the things that we’re already doing.”

The Virtual Incision team will review data from spaceMIRA after it returns to Earth to learn more.

“Don’t measure — cut twice.”

Asked for advice he would offer to designers and engineers at other device developers, Farritor said Virtual Incision has a “building ethos.”

“We make things and try them quickly, over and over and over again,” he said. “It’s very easy in the medical device industry to forget that and to try to get everything perfect before you try something. You have to look for ways to make little bets, to try small versions or test different aspects of what you’re trying to do in a physical way. and as clinically relevant as you can. So we really encourage that quick iteration and quick design process.”

“The saying is measure twice and cut once,” he continued. “Don’t measure. Just start cutting. Boards are cheap. If you’re measuring twice, you’re probably following a plan and following a plan means you’re probably not being as innovative as you could. So don’t measure — cut twice.”

Shane Farritor controls spaceMIRA while his Virtual Incision co-founder Dr. Dmitry Oleynikov watches.

Go to wtwh.me/virtualincision for more from Farritor and his team, including tips for medtech R&D in space.

www.medicaldesignandoutsourcing.com

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Photo courtesy of Virtual Incision

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The Mobi miniature, durable automated insulin patch pump worn on a hiker’s leg Image courtesy of Tandem Diabetes Care

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andem Diabetes Care EVP and Chief Strategy Officer Elizabeth Gasser didn’t exactly plan for the whirlwind past year or so.

Over about two months, Tandem announced continuous glucose monitor (CGM) integration with the latestgeneration technology from Dexcom and Abbott, launched its Tandem Source diabetes management platform and began the rollout of its new Mobi miniature insulin pump.

Those milestones added to the January 2023 acquisition of AMF Medical, adding a differentiated patch pump to the Tandem portfolio.

“We certainly didn’t plan that from the outset, [to] do four back-to-back releases,” Gasser said in an interview.

“Sometimes that’s how technology comes out along the way. It’s made for a busy, intense year.”

Tandem’s t:slim X2 has used Control IQ automated insulin delivery (AID) software for years. But the company’s newest offering highlights another diabetes care trend: miniaturization.

Those trends of automation and miniaturization help reduce the cognitive burden for patients; Gasser said:

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“We can make it more wearable and more convenient.”

Tandem’s origins Dick Allen, one of Tandem’s founding board members, encountered pumps when he had to help manage his granddaughter’s diabetes. He discovered that the insulin pump at the time was “a very funky medical device,” Gasser said, and Allen believed there had to be a better way for patients to manage diabetes “It’s fundamental in our space and it’s been a core tenet for Tandem since inception,” Gasser said. “From day one, the company set itself the goal of thinking about how to make this feel less like a medical device and make it easier to use and more appealing from a consumer perspective.”

That mindset led to the development of Tandem’s first t:slim pump and the following iterations. It developed into the company’s pursuit of varied CGM integration, providing more options to more patients. Mobi is yet another example of a smaller, durable device created to give patients yet another option. >>

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“These devices are on you 24/7,” Gasser said. “They’re as intimate as devices get, other than phones, which are very personal devices. Honing in on that idea of how do we make it feel more consumer and less medical is important.”

Leading the way in automation Automation, AI, algorithms and the like have long been a hot topic in medtech.

“The arc of technology points toward miniaturization and automation,” Gasser said.

Tandem Senior Director of Medical Affairs Laurel Messer sees AID moving toward systems that require less user interaction and burden.

“This is a partnership between better algorithms and exceptional wearability,” she said. “The future will include reduced user input, potentially getting to a point of a fully closed loop that does not require user interaction for

meals. We need to relentlessly drive AID toward this goal to limit the impact and burden of diabetes on people living life.”

Tandem’s Control IQ automatically monitors and regulates blood glucose.

The advanced hybrid closed-loop automated insulin delivery feature predicts and helps prevent high and low blood sugar. It leads to improved time in range throughout the day and night.

Gasser said she often invokes the Nest example when talking automation — the advent of cruise control and the capacity to implement machine learning so more and more can be done with automation. She calls it “the Nest– ification of tech,” referring to Google’s line of smart home devices.

Tandem approached this concept with Control IQ as an adaptive algorithm that can be iterated upon to continuously reduce the need for user engagement.

With diabetes, as Gasser explains it, treatment requires the administration of something physical and constant engagement. The aim is to take the physical burden out of the equation.

“Automation requires that we think about what wraps around it in terms of the user experience, that the interaction is intuitive, usable and builds trust,” Gasser said. “There’s the information that the patient makes visible through the applications themselves to help people understand their relationship with the automation. We spend a lot of time on it. It’s a significant investment.”

Making vital devices smaller Diabetes devices are getting smaller all the time. The Dexcom G7 is 60% smaller than the G6. Abbott’s FreeStyle Libre 3 is about the size of two stacked pennies, compared to Libre 2, which is about the size of two stacked quarters.

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TANDEM DIABETES CARE

Tandem is following suit with Mobi and eventually the Sigi patch pump from AMF Medical. Mobi is half the size of the t:slim X2 pump.

“There’s a consistent theme across CGM and pumps rolling into miniaturization,” Gasser said.

There remain limitations, though, such as capacity on the pump side.

With Mobi’s 200-unit cartridge and Sigi’s eventual 160-unit cartridge, the company continues to create smaller devices that can still provide the necessary levels of therapy to different patients with different needs.

Gasser said that while they can “pack quite a lot in a small place,” developers will eventually reach the boundaries of what’s

possible — at least in a durable way.

However, the company believes that its options and their shrinking sizes will enable more choice among patients.

“We’re allowing people to customize form factor, capacity and wearability to how they want to engage with their insulin therapy,” Gasser said.

Tandem Diabetes Care EVP and Chief Strategy Officer Elizabeth Gasser The Mobi insulin pump in use Image courtesy of Tandem Diabetes Care

The Mobi automated insulin pump with the accompanying mobile app

They said it: Diabetes tech leaders discuss current trends Insulet EVP of Innovation and Strategy Eric Benjamin on the space’s consumer-centric nature: “They are medical devices. They are also consumer devices. We live at the intersection of those two things. Diabetes is such a personal experience and decisions are influenced by the care team, but the ultimate choice is made by the person with diabetes. That’s central to how we think about it.”

Medtronic VP of Product Innovation Ali Dianaty on automation helping patients: “People managing their diabetes like to be in control. But after a week or so, they realize how much their system is doing for them. The thing we’re reminding them of is that they can get better outcomes with less work. As a result of that, they’re actually quite excited to get it.”

Image courtesy of Tandem Diabetes Care

Dexcom COO Jake Leach on the role of consumer choice and automation: “We’ve prioritized connectivity for more than a decade, which means our CGM systems are optimized to seamlessly connect with insulin delivery and digital health partners of all kinds, giving users freedom of choice in their diabetes journey and making Dexcom The Mobi automated the clear choice for AID.” insulin pump with the accompanying

mobile app.

Abbott Diabetes DVP of Technical Operations Marc Taub onImage the courtesy of Tandem Diabetes Care consumer focus in diabetes tech: “It’s really where medical device meets consumer electronics.

People have this amazingly intimate relationship with their sensor. They’re wearing it on the back of their arm.

They’re wearing it every day. They sleep with it. They shower with it.

They’re looking at the results on their phone up to dozens of times a day.”

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How Orthobond’s antimicrobial coating prevents contamination of medical devices JIM HAMMERAND MANAGING EDITOR

This scanning electron microscope image shows Orthobond’s Ostaguard antimicrobial coating killing methicillin-sensitive Staphylococcus aureus (MSSA) bacteria.

Image courtesy of Orthobond

A

new antimicrobial coating could go a long way in keeping medical devices free of infection-causing microbes after winning FDA de novo approval for its first indication.

Device developer Orthobond says its proprietary Ostaguard antimicrobial coating offers a new defense against bacteria, viruses and fungi that could contaminate the surface of an implantable device before it’s placed inside a patient.

The initial FDA approval is for Ostaguard-coated pedicle screws used in spinal fusions, but Orthobond said it has other devices treated with the technology in various stages of the regulatory

www.medicaldesignandoutsourcing.com

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process. An Ostaguard-coated oncology device from Onkos Surgical has also won FDA de novo approval.

Orthobond CEO David Nichols said the technology could eventually be used on a much wider range of orthopedic, oncology, neurovascular, plastic surgery and cardiac devices, or anywhere else infections are a concern.

In an exclusive interview with Medical Design & Outsourcing, Nichols — a former Zimmer Biomet executive — explained how Orthobond’s Ostaguard antimicrobial coating works and how other device developers might be able to take advantage. >>

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ORTHOBOND

Orthobond says Ostaguard achieves rapid, broad-spectrum

TM Achieves Rapid, Broad-spectrum Antimicrobial Activity Through a High Density of Positive OSTAGUARD antimicrobial activity through a high density of positive surface charge: Surface Charge

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➢ Patented (through 2037) process enables the installation of greater than 1x1016 Quat molecules per square centimeter of surface . ➢ Surface initiator ensures that antimicrobial molecules are bound to the surface preventing elution of the antimicrobial in the body.

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➢ Patented linker technology enables functionalization of nearly all metal and polymer surfaces.

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Illustration courtesy of Orthobond

Now that it has FDA approval, Orthobond plans to scale up manufacturing to meet demand and to submit a master file with the FDA to accelerate regulatory review for other device developers who want to use the technology on their products.

Private and Confidential © Copyright 2024 Orthobond Corporation. All rights reserved.

How Orthobond’s Ostaguard antimicrobial coating prevents contamination Orthobond was founded by Princeton University Chemistry Professor Emeritus Jeffrey Schwartz and the late Dr. Gregory Lutz. Schwartz was trying to use the ability to bond to the oxide layer for automotive tires and saw an opportunity for osteoconductivity.

Orthobond explains how Ostaguard kills microorganisms with multiple mechanisms of action: TM

OSTAGUARD

Kills Microorganisms with Multiple Mechanisms of Action

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Quat Surface

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2. Quat surfaces attack bacteria through multiple mechanisms allowing for broad-spectrum activity without the emergence of resistance.

Peptidoglycan Layer

Phospholipid Bilayer

Immobilization

Illustration courtesy of Orthobond

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1. Bacterial cell walls are coordinated structures with a net negative charge .

Perforation

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Destabilization

While that application didn’t outperform existing options, their research yielded an incredibly strong covalent bond that could prevent quaternary ammonium molecules (also called quats) from eluting into a patient’s body.

Orthobond covalently bonds its antimicrobial, polycationic molecules to the surface of an implant before packaging and sterilization.

It’s a wet chemistry process in which a medical device such as a hip, knee or screw is dunked in a chemical bath and then heated in an oven. That bonds a phosphonic acid layer only 4 or 5 nanometers thick to the oxide on the surface of the implant. Then an approximately four-hour polymerization process attaches quaternary ammonium molecules with densely packed, positively charged nitrogen at the end of the chain.

The resulting layer of positively charged, quaternary ammonium molecules on an implant’s surface measures only one-millionth of an inch and immobilizes, perforates and destablizes microbes.

“It’s like flypaper because bacteria is negatively charged and our surface is positively charged,” Nichols said.

“It actually draws them to our surface, puts little pin pricks in the bacteria and starts the death process. As they try to move around, it breaks them apart and kills them.”

FDA records describe the coating as a 12-methacryloyloxydodecyl pyridinium bromide (C21H34BrNO2) compound.

Because the technology neutralizes microbes mechanically, it even works on antibiotic-resistant bacteria like the Mu50 strain of methicillin-resistant Staphylococcus aureus (MRSA), which has evolved efflux pumps to remove antibiotics from its cells and render them ineffective.

“Our surface will kill that,” Nichols said.

The Ostaguard antimicrobial coating kills common infection-causing microbes such as Staphylococcus aureus, Pseudomonas aeruginosa, E. coli, methicillin-resistant Staphylococcus aureus (MRSA), E. cloacae and C. acnes.

The coating technology has not been evaluated in human clinical trials, but Orthobond said it found no evidence of local or systemic toxicity in sheep, guinea pig and canine testing.

www.medicaldesignandoutsourcing.com

6/26/24 2:46 PM

ORTHOBOND

Orthobond won FDA de novo approval for its Ostaguard antimicrobial coating on SeaSpine Mariner pedicle screws.

Image courtesy of Orthobond

Antimicrobial coating know-how for device designer and engineers The company plans to keep the technology inside its facility to maintain proprietary control instead of licensing it for device manufacturers to use on their own production lines. The process currently takes two or three days before the treated products are packed, sterilized and sent back to the manufacturer (or shipped directly to the manufacturer’s packaging and sterilization provider).

“It adds a step in the supply chain, but most of that’s outsourced anyway,” Nichols said. “You can imagine a major medical devicemaker would manufacture it, clean it, ship it to be treated, and then it goes to sterile packaging from there.”

Applications for the antimicrobial coating permanent include all sorts of implants, but also catheters, surgical instruments, and dialysis machines.

The coating is compatible with all medtech metals, including cobalt chrome, stainless steel, titanium.

Orthobond has also experimented with the coating process for different materials, such as a product with silicone epoxy that required a lower temperature, and a spray method for electronics that can’t be dipped in a fluid bath.

“Anything with an oxide layer’s easy: titanium oxide, chromium oxide,” Nichols said. “For the epoxy, we had to put an oxide layer on, so we put a layer of zirconium oxide on and then we put our chemistry on. We’ve figured out the epoxy and the silicone.”

Teflon — like you’d find on some heart valves, for instance — is still a challenge, “but my chemists love that,” he said. “They say they can do it, but we have not done that yet.”

Nichols said the Ostaguard antimicrobial coating “holds up really well to gamma” sterilization, but applying the coating to devices sterilized with ethylene oxide or steam requires some fine-tuning.

Regulatory strategy is probably the biggest consideration for device engineers and designers who might want to use the antimicrobial coating, Nichols said. Using breast implants as an example, he said a devicemaker might want to start with a Class II breast tissue expander because the regulatory pathway would be easier than Class III breast implants.

Nichols said one area for improvement is application efficiency.

Coating permanent implantables with a fluid bath results in a lot of waste, but the cost is insignificant if you’re using it for an artificial hip or knee joint.

Orthobond will work to reduce the cost of application to make it a better fit for temporarily placed devices like catheters or reusable instruments.

“We’ve got to bring the price down probably tenfold, but it will work,” Nichols said.

www.medicaldesignandoutsourcing.com

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Pedicle screws before (left) and after (right) being coated with Orthobond’s Ostaguard antimicrobial technology Photo courtesy of Orthobond

Orthobond CEO David Nichols

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DeviceTalks Managing Editor Kayleen Brown and Advanced Sterilization Products Global President Chad Rohrer at DeviceTalks Boston 2024 Photo by Jeff Pinette for DeviceTalks

See the future of medtech with DeviceTalks Spotlights To m S a l e m i | D e v i c e Ta l k s E d i t o r i a l Director |

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hat does the future hold for medical device developers?

That’s the question we try to answer at DeviceTalks to help medical device companies design and manufacture more effective products at lower costs, positioning them for quicker clinical adoption.

We invited over a dozen device companies to answer that question and more in our recording studio at DeviceTalks Boston 2024 in May. You can find their answers on our new DeviceTalks Spotlight page — and you can even join the conversation by asking questions of your own directly to our experts.

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Here’s a small sampling of some of their insights for anyone designing medical devices.

The need for empathy Catherine Jameson, lead engineer at Nova, hopes medical device designers will work harder to incorporate everyone in design, including patients.

“We talk a lot about empathy, but sometimes that can look like pity or sympathy,” she said.

What device developers really need to do is include patients’ experience in the design process “so we’re respecting what they already know about their bodies and what they need.”

www.medicaldesignandoutsourcing.com

6/26/24 12:28 AM

Think beyond the prototype Diane Hunter, director of engineering at Acme Monaco, said the engineering and manufacturing company anticipates future devices will require more custom designs for unique approaches to solve problems. Device designers should take unorthodox steps with new designs, she said, but the reality of manufacturing devices — like the tolerances of materials — should be given equal weight.

“It’s not that hard to make a prototype of a product,” Hunter said.

“But when you want to take that to commercialization and you’re looking at high volumes of manufacturing, you not only want the product to be a great design but you want it to be cost-effective.”

Risk of AI bias Jeanette Numbers, founder and CEO of Nova, warned the risk of bias in device design could be compounded by the introduction of artificial intelligence if designers aren’t importing data on broad patient populations.

“If we’re not training our AI modules to include everyone, then we’re just going to get more of the same,” she said.

The importance of biocompatibility Matthew Heidecker, VP and principal scientist at PSN Labs, said regulators who previously focused on the impact of chemicals like cadmium, lead, and mercury are now homing in on organic molecules used in device manufacturing.

“The FDA really pushes for manufacturers to understand that your device works from a biocomp standpoint on day one,” Heidecker said.

Manufacturers need to know what impact long-time use, reuse, sterilization and other physical demands will have on device materials and in patients.

A fresh look at sterilization Chad Rohrer, global president of Advanced Sterilization Products (ASP), advised medical device designers to think about how their devices will withstand sterilization “as early as possible.”

As ASP and other sterilization leaders look at ethylene oxide (EtO) alternatives and modified approaches in light of health risks and new regulations, Rohrer said AI could play a role.

“Today, up to 70 percent of instruments that come on a tray are not used … and you’re reprocessing them still,” he said.

Rise of digital modeling Massachusetts Institute of Technology biomedical professor Ellen Roche said the use of digital twins like those developed by Dassault Systemes will continue to accelerate device design and development. Used largely in building prototypes, digital simulation will ultimately assist in clinical trials and clinical treatment.

“There are multiple stages at which these tools can benefit the overall workflow,” Roche said.

Adoption challenges include training and infrastructure to run the digital tests.

“But we’re working to democratize it in some way and using AI” to accelerate the simulation process, she said.

Easier upgrades Kevin Dempsey, senior director of business development at Emphysys, a Tecan Group Company, said he’d like to see the medical industry adopt the dynamics of consumer technology with multiple updates and enhancements.

“There are many fantastic ideas out there, but we need to bring them to the patient as soon as we can,” Dempsey said.

Medical device developers could build a simple but powerful implantable device that’s designed to accept upgrades through the years so patients benefit from the latest advances, he suggested.

Finding common platforms Dr. Radu Iancu, CEO and founder of KeborMed, envisions the day when medical device manufacturers stop trying to solve connectivity and cybersecurity concerns independent of one another. Instead, the industry will settle on a small number of platforms upon which devices can operate.

“Once people understand that it’s much easier to raise all ships at the same time — and I’m talking about from the largest med device company to the earliest startup — that’s when it’s becoming a tidal wave,” Iancu said.

Go to wtwh.me/dtspotlight for the entire set of interviews. www.medicaldesignandoutsourcing.com

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PSN Labs VP and Principal Scientist Matthew Heidecker

Massachusetts Institute of Technology Biomedical Professor Ellen Roche

Senior Director of Business Development at Emphysys, a Tecan Group Company, Kevin Dempsey

KeborMed Founder and CEO Dr. Radu Iancu 7 • 2024

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