Medical Design & Outsourcing – JULY 2022

www.medicaldesignandoutsourcing.com JULY 2022

FDA CAN’T EXPLAIN DROP IN DEVICE RECALLS, BUT EXPERTS POINT TO COVID DISRUPTION

DEXCOM CEO EXPECTS ‘SCIENCE BOOM’ WITH CGM, AUTOMATED INSULIN DELIVERY

www.medicaldesignandoutsourcing.com JULY 2022

FDA CAN’T EXPLAIN DROP IN DEVICE RECALLS, BUT EXPERTS POINT TO COVID DISRUPTION

DEXCOM CEO EXPECTS ‘SCIENCE BOOM’ WITH CGM, AUTOMATED INSULIN DELIVERY

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22.05.20 10:49

Medical Design & OUTSOURCING EDITORIAL S TA F F

WATCH

EDITORIAL

WEB DEV/DIGITAL OPERATIONS

DIGITAL MARKETING

Executive Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker

Web Development Manager B. David Miyares dmiyares@wtwhmedia.com @wtwh_webdave

VP, Digital Marketing Virginia Goulding vgoulding@wtwhmedia.com @wtwh_virginia

Managing Editor Jim Hammerand jhammerand@wtwhmedia.com

Digital Media Manager Patrick Curran pcurran@wtwhmedia.com @wtwhseopatrick

Digital Marketing Manager Taylor Meade tmeade@wtwhmedia.com @WTWH_Taylor

Front End Developer Melissa Annand mannand@wtwhmedia.com

Digital Marketing Coordinator Matthew Kulkin mkulkin@wtwhmedia.com @WTWH_Matt

Senior Editor Danielle Kirsh dkirsh@wtwhmedia.com

2011 - 2020

Pharma Editor Brian Buntz bbuntz@wtwhmedia.com Associate Editor Sean Whooley swhooley@wtwhmedia.com @SeanWhooleyWTWH

2014 Winner

Editorial Director DeviceTalks Tom Salemi tsalemi@wtwhmedia.com

2014 - 2016

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

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

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Graphic Designer Mariel Evans mevans@wtwhmedia.com @wtwh_mariel

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.

Web Dev./Digital Production Elise Ondak eondak@wtwhmedia.com

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medicaldesignandoutsourcing.com July 2022 ∞ Vol8 No4

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devicetalks.com

4

Medical Design & Outsourcing

7 • 2022

NEW!

HERE’S WHAT WE SEE

4 AXIS SERVO from

Innovators shake up the Pharma 50

2.25”

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s a father raising a toddler and an infant, I was relieved by the latest milestone in the COVID-19 pandemic: the authorization of vaccines for children between 6 months and 5 years.

The good news came as Pharma Editor Brian Buntz and the rest of our team were putting the final touches on this edition’s Pharma 50 project. It’s our annual ranking of the biggest pharmaceutical companies by global revenue, featured on our affiliated Drug Discovery & Development website. (Our Big 100 report on largest medical device companies is out in September!)

Pfizer shot from the No. 9 spot on last year’s ranking to No. 1 this year with nearly $81.3 billion in revenue, pushing Sinopharm out of the top spot. Pfizer’s Comirnaty was the top-selling drug of 2021, and the vaccine’s success didn’t only boost Pfizer.

The drugmaker’s partner on the vaccine, BioNTech, made its Pharma 50 debut at No. 18 this year, thanks almost entirely to Comirnaty sales.

Moderna also made the Pharma 50 for the first time this year, ranking No. 23 thanks to its own mRNA COVID vaccine. Meanwhile, competing vaccine maker Janssen (Johnson & Johnson’s pharmaceutical segment) climbed from No. 6 to No. 4. With new variants emerging regularly, it’s not hard to imagine another shake-up in next year’s rankings from another blockbuster vaccine, hopefully one that prevents infection entirely.

COVID disruption was a likely suspect behind the near-record-low number of FDA medical device recalls in the agency’s most recent year.

That’s according to an analysis by Senior Editor Danielle Kirsh of recall data and interviews with the FDA and regulatory experts in this edition. It’s a reminder of the importance of continued vigilance and improvement from the industry and Jim Hammerand regulators alike.

Managing Editor Medical Design & Outsourcing On the diabetes front, Associate jhammerand@wtwhmedia.com Editor Sean Whooley interviewed Dexcom CEO Kevin Sayer about the future of integrated automated insulin delivery following FDA clearance of the Dexcom G7 continuous glucose monitoring system. AI algorithms and expanded data collection are going to lead to a diabetes “science boom” over the next decade, Sayer said.

This edition is also full of innovative insights shared at DeviceTalks Boston by industry leaders from Medtronic, Boston Scientific, Insulet and others. Highlights include an exploration of pulsed-field ablation for treating atrial fibrillation, Stryker’s involvement of users when designing orthopedic products for the digital age, and how new technology is changing how surgeons work in the operating room.

Find all this and much more in our latest edition of Medical Design & Outsourcing. Enjoy — and thanks for reading.

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• Direct ••Direct •Direct Direct C-Axis C-Axis C-Axis Indexing Indexing Indexing C-Axis Indexing • Axis ••Axis •Axis Axis Feed Feed Feed Motion Motion Motion Overlap Overlap Overlap Feed Motion Overlap Function Function Function Function • Fast ••Fast •Fast Processing FastProcessing Processing & shorter &&shorter &shorter shorter Processing cycle cycle cycle time time time with with with NCNC unit unit cycle time with NCNCunit unit • User • User • User friendly friendly friendly forfor ease forease ease of of of • User friendly for ease of operations operations operations operations • Cincom • Cincom • Cincom Control Control Control reduces reduces reduces idleidleidle •time Cincom Control reduces idle time time andand allows and allows allows easy easy easy setup setup setup time and allows easy setup • LFV • LFV • (Low LFV(Low (Low Frequency Frequency Frequency VibraVibraVibra•tion) LFV Frequency Vibration) tion) & Laser &(Low Laser & Laser Technology Technology Technology tion) &available LaserasTechnology now now now available available as anasan option anoption option now available as an option

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CONTRIBUTORS

CHEKAL

BARROS

KACEDON

DALEY

RITTER

SAWICKI

MARCELO BARROS is an associate at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. He focuses on patent litigation in federal courts and post-grant review proceedings before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO). With a background in biomedical engineering, he brings technical versatility in working with companies in the life sciences as well as electrical and computer technology sectors.

KATHLEEN DALEY is a partner at Finnegan with significant experience in trial and appellate litigation.

She has led litigation teams and been involved in all aspects of patent litigation, in district court and the U.S. International Trade Commission (ITC), and she has argued appeals before the U.S. Court of Appeals for the Federal Circuit.

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Medical Design & Outsourcing

7 • 2022

HELMINK

XU

DANA HELMINK is senior director of audiology/ clinical education at Widex USA. With over 15 years in product management, Helmink applies her experience in user-centered design and usability testing to develop innovative training programs. She earned her master of arts in audiology from Northern Illinois University and her doctor of audiology degree from Salus University.

She previously worked in clinical audiology and served more than 10 years on the Illinois Academy of Audiology board of directors.

REX CHEKAL is a principal product designer at TXI (formerly Table XI), a product innovation firm based on one big idea in three small words: tech done right.

Since 2002, Table XI has partnered with Fortune 100 companies, startups in Singapore and Tokyo, industry leaders in London and Los Angeles, and missiondriven nonprofits in its hometown of Chicago.

DARREN GILMER is senior manufacturing engineering manager at Intricon, a joint development manufacturer that makes microelectronic medical components, technology and assemblies for interventional, implantable and body-worn medical devices across a range of device platforms for global customers. Gilmer has more than 30 years of experience collaborating with R&D and new product development through manufacturing, including working on surface mount assembly processes and assembly circuitry.

GILMER

BRIAN KACEDON is a partner at Finnegan and a recognized authority in IP transactions. He has drafted and negotiated hundreds of agreements across all technologies and is designated as a certified licensing professional (CLP). Brian has also successfully litigated multiple lawsuits and arbitrations based on his extensive transactional experience.

MATTHEW RITTER is an associate at Finnegan who focuses primarily on patent litigation and patent application drafting within the electronic devices space. His technical background includes electrical and computer engineering.

DAVE SAWICKI is the senior application specialist and sales director of IPT America – Xebec Deburring Technologies, a manufacturer of automated deburring and surface finishing solutions.

CHUANBO XU is senior director of clinical development at Freenome. With 20 years of clinical experience, he has led teams across disciplines in developing products that address unmet medical needs.

www.medicaldesign&outsourcing.com

CONTENTS

medicaldesignandoutsourcing.com ∞ July 2022 ∞ Vol8 No4

DEPARTMENTS HERE’S WHAT WE SEE:

8

38

Innovators shake up the Pharma 50

10

CONTRIBUTORS

14

MANUFACTURING:

18

ON THE COVER WHAT IS PULSED-FIELD ABLATION? HERE’S WHAT YOU NEED TO KNOW

Tips for vetting contract manufacturers

Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston.

MACHINING:

Deburring and finishing for beautiful, functional medical devices

22 PRODUCT DESIGN & DEVELOPMENT: Tolerance stack-up

26 IP ISSUES:

Medical device licensing pitfalls to avoid

28 SOFTWARE:

How to boost adoption in digital health

32 REGULATORY:

How to leverage technology to drive diversity in clinical studies

34 COMPONENTS:

Why filter bank design is critical for effective hearing aids

38 TUBING TALKS:

What is pulsed-field ablation?

Here’s what you need to know

44 ORTHOPEDICS:

How Stryker includes users for product design in the digital age

60 DEVICETALKS:

They said it at DeviceTalks Boston

Medical Design & Outsourcing

46 FDA CAN’T EXPLAIN DROP IN DEVICE RECALLS, BUT EXPERTS POINT TO COVID DISRUPTION

The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures.

52 DEXCOM CEO EXPECTS ‘SCIENCE BOOM’ WITH CGM, AUTOMATED INSULIN DELIVERY

With the G7 nearing FDA clearance, Dexcom leadership foresees major innovations for integrated automated insulin delivery down the line.

56 2022 PHARMA 50: THE 50 LARGEST PHARMACEUTICAL COMPANIES

The pandemic highlighted the potential of new R&D strategies for drug developers.

64 AD INDEX 12

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7 • 2022

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MANUFACTURING

Photo courtesy of Adobe Stock

Tips for vetting contract manufacturers Fictiv CEO Dave Evans finds and vets contract manufacturers to help medical device developers get products in spec and on time.

G

Jim Hammerand | Managing Editor |

ood help is hard to find.

Fictiv co-founder and CEO Dave Evans has built a business around solving that challenge.

San Francisco–based Fictiv finds and vets contract manufacturers to connect them with companies like medical device developers.

After closing a $100 million Series E funding round this spring, Evans spoke with Medical Design & Outsourcing to share some tips and tricks around vetting potential manufacturing partners. This conversation has been lightly edited for space and clarity.

MDO: What are the biggest things you look for?

Evans: You want to look at that manufacturing partner and say, “What are they really, really good at? What is their core expertise?” Because what happens — especially in the medical contract manufacturing (CM) world — let’s say they start off and they’re really good with a certain type of PCBA or a certain chip set. From there they tend to add all these capabilities

14

Medical Design & Outsourcing

7 • 2022

on to get more and more business. So they might add plastic injection molding or they might add wiring harnesses. But these aren’t core capabilities. And then even beyond that second layer, they start building a network of suppliers in their world where they are outsourcing that work. Let’s say they outsource sheet metal — that outsource manufacturer then might outsource the powder coating or the threading or welding that goes on it. So all of a sudden if you are an engineering manager at a medical device company, you might be choosing that contract manufacturer because of a core capability, but then you’re leveraging them for all these other things which become second-, third- and fourth-tier, kind of like arm’s distance away. Then when you’re expecting a device to come back on June 15 and it’s late, it generally isn’t that first party’s fault. It’s the third, fourth and fifth layer. And so one of the things that we actually require in our vetting of the 250 manufacturing partners is there’s no subcontracting allowed. … (continued on page 16)

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or certifications? What are your practices for constantly reevaluating your system?

Do you have a lean manufacturing principal, do you have Six Sigma experts that are constantly looking at continuous improvement practices? How are your people treated? What is your minimum pay? What does your turnover and retention rate look like? There’s this whole list, think of it as a hundred-point checklist that we go through to decide is this a world-class manufacturing facility?

Fictiv co-founder and CEO Dave Evans

"Whether you're running a manufacturing facility or you're building medical equipment, what's your agility plan? Do you have one? And if you don't, that's a big red flag."

How much data do these manufacturers you’re looking at have on a quality rating, both in terms of an in-spec rating and ontime delivery? How much outsourcing are they doing and how much control of their supply chain do they really have? These should be big, big questions as you’re looking to really vet your supply base.

MDO: Is it a warning sign if they won’t hand that over?

Evans: Yeah, generally a red flag. Most of those CMs will say, “We don’t share our network of all our vendors, that’s our core IP.” Or they’re like, “Yeah, we don’t want to tell you our on-time performance.”

And generally, it’s because they don’t have the data, because a lot of that ontime information lives in spreadsheets and maybe some ERP system, if they have it.

MDO: How do you zero in on a company’s core competencies and what they do better than anyone else?

Evans: I always start by looking in the mirror. For Fictiv, first and foremost, I think why people choose us is quality.

Our digital systems combined with our people within this whole network gets you a better quality product out the door. Then we go to these suppliers and we say, “Our job is to bring on the best manufacturing partners to deliver quality.” What do we look for there?

We want to look for not just one good product, but how have you done that over an entire year? What audits have you done both internally, but also from ISO

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Medical Design & Outsourcing

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www.medicaldesignandoutsourcing.com

MDO: What are you looking for when visiting in person?

Evans: We’re looking at shift schedules, machine maintenance logs, work travelers and how parts flow through a facility.

We’re talking to upper management and talking about workforce retention all the way through to how’s the quality department run and what practices do you have in place, what’s written down?

And then we’re running real test parts through that to validate that workflow. …

There’s a whole team of people and that’s their full-time job. We have folks full-time in India, in China, in the United States, We operate in 27 states in the U.S. MDO: Do you prefer partners with remote workforces?

Evans: 100%. Remote employees are happier, more productive and you get to leverage the talents of the world, let alone just geographically in the U.S. … I think you build a more resilient workforce as well that way.

MDO: What’s the No. 1 red flag you look for?

Evans: The future is pretty volatile and opaque right now. We have still a pandemic going on, we have a global conflict, we have volatility in the financial markets. There’s never been a more important time to have plan A, B and C, and to have real agility built into your strategy where you can move as things move. Whether you’re running a manufacturing facility or you’re building medical equipment, what’s your agility plan? Do you have one? And if you don’t, that’s a big red flag.

MDO: What are some green lights you love to see?

Evans: Folks who are open to change, especially in the medical world where there’s a lot of risk. The creativity to

leverage technology outside of the medical industry, maybe to bring it in and try things in a new way, those are folks that I think are really excelling in this environment. We could see that across the board with all the medical innovations over the last two years as it relates to the pandemic. Having an appetite to try new things — those tend to be guiding lights.

MDO: What are some exciting innovations you’re seeing in the industry?

Evans: Especially on the medical side and in a lot of the mechanical aspects of plastics and metals, we’re seeing a hybrid approach. So you might 3D print something and then machine it for tolerances. You are taking geometries which could never be produced before, but you’re getting the precision of a lot of traditional processes. This combo of additive plus subtractive is really exciting.

There’s a lot of work being done in the resin space as well for different medical devices that need biocompatibility.

For injection molding, we’re seeing a lot of work where injection molding is being used earlier in the development process, whereas traditionally I think a lot of medical device companies really waited into the final stages of, say, an FDA trial approval for real materials. For example, we’re turning around injection molded parts in two and a half weeks, so that’s really changing new product development where folks are leveraging injection molding earlier on in their development cycle.

7 • 2022

Medical Design & Outsourcing

17

MACHINING

Deburring and finishing for beautiful, functional medical devices The latest automated cutting tools help medical device manufacturers meet strict specs and high demand.

An engineer inspects artificial hip joint parts.

Photo courtesy of Xebec

I Dave Sawicki | Xebec |

18

Medical Design & Outsourcing

ncreasing demand and advances in technology are driving growth in the medical device industry. Chronic diseases are more prevalent, and the aging population is larger, contributing to the demand for highly regulated Class III medical devices such as pacemakers, artificial hips and heart valves. And focused research and development mean today’s medical devices must perform better, longer.

This market reality puts more pressure on medical device manufacturers. To pass inspection and guarantee longevity and performance, they must achieve high-quality surface finishes and tighter dimensional tolerances. To meet demand, they must do so as quickly and efficiently as possible while still complying with strict industry standards and regulations.

Deburring and surface finishing are consequential phases in producing medical parts and devices requiring precision and quality. One missed detail can discount all prior work on the piece, turning it to scrap or sending it back through production.

And one overlooked detail that still passes inspection could have detrimental consequences downstream.

7 • 2022

With the industry’s tightening standards, high demand and greater device complexity, automating these processes with highquality tools like ceramic fiber brushes that have a long tool life and the most consistent performance can alleviate strain on production capacity and even allow manufacturers to take on more work despite the labor shortage.

And these unique cutting tools with flexible bristles can remove burrs without altering part dimensions to maintain dimensional integrity.

Why medical devices must be beautiful Most medical tools and devices must be burr-free after production. Many must also have mirror-fine surface finishes. Those that don’t require a mirror finish have strict finishing and polishing requirements to prevent irritation and infection.

These requirements are not about producing an attractive part. They’re about producing a functional part that will last its expected life and perform smoothly. For implants, these requirements also affirm biocompatibility, ensuring parts are suitable for implantation and won’t be rejected or vulnerable to stress or corrosion. (continued on page 20)

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MACHINING

For load-bearing devices, they affirm the parts will sustain performance and withstand pressure.

Requirements are particularly strict with FDA Class III and Health Canada Class IV devices on which human life will depend or pose a high risk for the patient. With demand exploding for medical devices like joint replacements and pacemakers as populations age, the selection of materials used by medical implant and device manufacturers continues to change. Manufacturers are seeking more innovative ways to improve the quality and longevity of implants and devices, and they need a high-tech tool to deburr and finish these materials to precise specifications, like those with ceramic fibers that are self-sharpening, exposing new cutting edges as they wear.

If a manufacturer doesn’t have longlasting tools to meet these specifications on time, production and throughput will suffer. For instance, many manufacturers still have employees deburring and finishing these critical parts by hand. This is time-consuming and difficult to produce quality parts consistently. And the reality is finding skilled labor for such work is becoming more challenging.

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Take a knee (for example) One great example of a medical device that must be precisely produced is a knee replacement. There are two main components that operate together to perform the function of the knee: the concave cup and the convex ball. These parts are meant to swivel and pivot as a natural knee would.

To achieve these motions, the parts must be manufactured to tight tolerances, cutter marks removed and precisely polished. The complex shapes of these parts mean it’s challenging to deburr and finish them by hand or with inadequate automated tools. Employees who hand deburr must remove the tiniest marks and create perfect surface finishes, which inevitably yields inconsistent results (because they’re only human and get tired as the day goes on) and leads to frequent and costly scrap.

If a knee replacement isn’t to spec or quality but passes inspection and is implanted in a patient, it might result in misalignment, instability, corrosion, premature wear and other issues. This could affect patient quality of life and generate a higher cost of care. It can even lead to device failure.

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Robotic finishing and deburring tools can do the job in seconds or minutes instead of hours.

Image courtesy of Xebec

Deburring and finishing with an automated cutting-edge solution that works like a cutting tool turns out highquality, consistent results. Such a tool can shrink the hours-long processes of deburring and finishing down to minutes or even seconds.

Achieve beautiful outcomes in less time Medical device manufacturers can achieve better, higher-quality results and even increase production when they automate deburring and finishing with tools like ceramic fiber brushes that can be incorporated into the CNC program. These brushes perform like long-lasting cutting tools, completing the deburring and finishing process in one step with impressive outcomes.

Choosing the right deburring tools to automate production helps manufacturers remove all burrs and achieve impressive finishes as required by the customer.

Manufacturers can more readily meet strict criteria while saving time and labor by reducing manual work. They can even save post-machining polishing time as the tool improves finish while the part is on the machine.

These benefits are key to maintaining the reputations of premier medical device manufacturers by consistently producing superior quality parts and reducing the likelihood of downstream issues.

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PRODUCT DESIGN & DEVELOPMENT

Tolerance stack-up: Insight into the inner workings of high-density microelectronic medical devices Tolerance stack-up is a defining design concept to ensure new products are built efficiently and effectively.

A Darren Gilmer Intricon

t a time when the future of micro miniature medical devices seems unlimited, one fundamental reality remains firmly in place — the sizes and shapes of human anatomy.

From blood vessels to ear canals, respiratory passages to neural pathways, the physical dimensions of the body available for life-saving and lifeenhancing medical therapies exist within a minimum and maximum range. For medical devices, the general rule for reaching deeper into the tiniest areas of the body is “the smaller, the better.”

In theory, a single medical device can do many things even in the smallest anatomical feature. In actuality, building a multi-functional micromedical tool and incorporating the electronic circuits that may be required to empower it call for proven expertise from the earliest stages of design

all the way through to full-scale production.

The greater the density of componentry, the more precision and validation is required for reliable performance.

Tolerance stack-up is a defining concept for designing new products to ensure they’re built efficiently and effectively during production, and it’s much more than a theoretical construct. It’s how the device is constructed with all layers of functionality — electrical, mechanical and software/firmware — working together according to specification and within 22

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performance requirements, the sum total determining the eventual success for producing the device.

Electrical: Where one one-thousandth counts — a lot Even a microelectronic circuit so small a half dozen could fit onto the surface of a dime can include multiple active and passive components, metallic wiring, traces and vias on the circuit board, memory units for device instructions and more.

How the layers relate to each other influences more than the overall reliability of the device. The relationship also determines the manufacturing viability and production costs of the product. In this case, the components, materials, and manufacturing tolerances can refer to both the physical dimensions of the parts and performance parameters.

Tiny electronic components next to a dime for scale Photo courtesy of Intricon

In terms of product efficacy, most people will never know the critical difference made by a half of onethousandth of an inch in the positioning of electrical components and subassemblies. However, in terms of production, optimal positioning can mean higher yields which keep costs lower and lead to more finished devices in market to meet the needs of clinicians. (continued on page 24)

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PRODUCT DESIGN & DEVELOPMENT

EXAMPLE SET OF TOLERANCE CALL-OUTS

GOLD WIRE X +/– .00X

IMPROPER/ MISALIGNED STACK-UP TOLERANCES

X +/– .00X

X +/– .000X

XnF +/– 10%

X +/– .00X

XnF +/– 1%

X +/– .000X

X +/– .00X

.00X

X +/– .00X

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Images courtesy of Intricon

Mechanical: Physical tolerances play a part, too Body-worn devices typically incorporate input sensors, device controls, output functionality, power supplies or charging ports and more. Interventional surgical tools often add navigational aids such as electromagnetic sensors. These devices can also include low-power communications capabilities.

Specifying, sourcing and incorporating the mechanical parts of a medical device adds even more layers to the tolerance stack-up along with the electrical tolerances and “cross-talk” of the active and passive components.

Some components already exist. Some components can be modified. And some components require all-new design, testing and production. Before the production lines start rolling at full capacity, all tolerances must be evaluated and validated.

Software/firmware: Onboard intel at work At the heart of today’s high density, micro miniature medical devices are the instructions that flow through the electrical circuitry and drive the mechanical assemblies.

As devices get smaller and smaller, more functionalities require more memory. Accommodating this requirement adds an extra layer of complexity to the intricate tolerance stack-ups within the device.

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Supply chain considerations: Different suppliers may have different specifications Now more than ever, supply chain management figures prominently into sourcing and manufacturing assemblies and sub-assemblies needed for micro miniature medical devices.

Specialized components are often available from more than one supplier, but knowing which source can actually meet the tolerance specifications required for cost-effective, high-volume manufacturing can only come from experience, not trial and error.

More device capabilities mean tolerance stack-up is even more important Looking ahead, micro miniature medical devices will continue to do more and more, particularly with data that’s generated, stored and transmitted during a procedure or on an ongoing basis for body-worn devices.

Integration with cloud-based applications that harness the power of machine learning and insights of artificial intelligence places expand the potential of every medical device even as the physical dimensions of human anatomy remain constant.

Taking into account the everincreasing complexity of tolerance stackups and designing for manufacturability is critical to ensure continued innovation in medical device engineering.

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IP ISSUES

Prevent costly disputes caused by these common mistakes in patent license agreements.

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Marcelo Barros Finnegan

Kathleen Daley Finnegan

Brian Kacedon Finnegan

Matthew Ritter Finnegan

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L

icensing and other technology transfer agreements can be critical for medical device companies that invest significantly into new technology R&D and seek and obtain intellectual property protection for those investments. But if these agreements are not carefully drafted, they can create more problems than they solve.

To avoid the common pitfalls that tend to create issues in patent license agreements, watch out for a few of the most common mistakes when drafting them.

Common drafting mistakes First and foremost, license agreements should avoid terms that are ambiguous and vague.

Imprecise language can lead to uncertainty on the part of both parties to the agreement, including on what is licensed, the scope of the license, and other terms. Such uncertainty can lead to disputes, including litigation.

As with any good legal document, the key terms in the agreement should be properly defined. For patent license agreements, key terms include licensed patents, the licensed product, any improvements included in the license grant, and any field of use limitation.

Carefully defining and agreeing on those key components of the agreement can go a long way to avoiding disputes that go to the heart of the agreement.

Ambiguity or vagueness in an agreement can arise by using broad, poorly defined terms. Terms like “relating to” or “flowing from” are limitless and have no clear boundary. A careful practitioner should consider avoiding such terms or including non-exhaustive statements of what does and does not relate to, or flow from, the relevant component or device to provide boundaries and guidance for future readers.

Another source of ambiguity can come from imprecise words. This can be an issue even when synonyms are chosen. Though vocabulary variety makes for good prose, a patent license agreement should never read like James Joyce. A drafter should strive to consistently, and persistently, use precise words throughout the license agreement. The case of SiRF Technology Incorporated v. ITC is a good illustration of ambiguous language: an employee assigned to their employer “all inventions ... which are related to or useful in the business of the [e]mployer.” What does it mean for an invention to be related to or useful in a particular business? As the

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Image courtesy of Adobe Stock

Medical device licensing pitfalls to avoid

court noted, those terms “are inherently ambiguous.” Ultimately, it took litigation to determine that the patent at issue did not belong to that employer.

Agreements involving medical device technologies can also benefit from precision when defining terms related to exclusivity, field-of-use, or improvements. For example, technologies may be used in different fields. There is no requirement, however, that the owner of the technology license all fields together.

Ideally, each license agreement will be tailored to the specific field-of-use for which the licensee intends to use the technology (e.g., pulse generators used for pacing versus spinal stimulation). In field-of-use licenses, the patent holder should also seek to have the licensee promise not to practice outside the licensed field. By including such an express promise, the patent holder reduces the risk of a court finding that the licensee’s use of the technology outside its licensed field is not a breach of the agreement.

Imprecise license grants When it comes to a patent license, the scope of the license grant is one of the most important terms as it tells the parties what conduct is permitted under the agreement. Under the patent statute, a patent holder has the right to exclude others from making, using, selling, offering for sale, and importing the patented invention. The patent holder can license all of these rights or some of them. Do the parties intend for the licensee to be able to make and sell products only, or can the licensee also import the products? The grant provision should be unambiguous in what is being licensed. Though the phrase “make, use, and sell” appears complete, it fails to include the act of importation. And language such as “practice” or “exploit” the patent should be avoided as it is not clear what actions constitute practicing or exploiting the patent. That language is not in the statute and does not specifically relate to any particular right under the statute. When drafting patent license agreements, it is recommended that drafters stick to the relevant statutory language unless the parties specifically intend to agree to less than the statutory right: for patents, emulate the language in 35 U.S.C. § 271.

Another important consideration is who is being licensed. Does the license extend to a company’s subsidiaries and related companies and what happens if the licensee is acquired by another company or acquires a company? These issues should be addressed to avoid potential disputes later.

Mistakes in payment and reporting Another important part of a patent license agreement is the payment term. How much does the licensee have to pay? How is the amount determined? When are payments due? These are all questions that should be answered in the agreement.

Commonly, a license agreement will provide a particular royalty to be paid for each product sold. But what is the base on which the royalty is applied?

The most common royalty base is the net sales price. But even such a commonly used phrase should be carefully defined to specify what deductions may be taken

from gross sales to arrive at “net sales,” such as taxes, insurance, shipping, and other relevant costs.

It is also common for licenses to fail to provide for interest on late payments, or what should be done if a party overpays. Another common mistake is for the license to fail to account for situations that are not “sales,” such as leases, donations, or samples. Other mistakes to be avoided include failing to include the currency or time horizon for currency conversions, as well as the withholding of taxes.

Avoiding these mistakes will help make sure that the final license agreement reflects the parties’ intent and hopefully avoids unnecessary litigation. Given the fact that medical device technology is often licensed, it’s important to understand the common pitfalls and discuss licensing strategy early in the development of a particular technology.

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SOFTWARE

Theragen’s mobile app includes metrics to help spine fusion patients track their progress.

Photos courtesy of Theragen

Patients and physicians: How to boost adoption in digital health Digital health firms can empower the best possible medical care by recognizing the common objectives of patients and physicians.

T

Rex Chekal TXI 28

Medical Design & Outsourcing

o drive adoption, digital health application design requires consideration of two distinct user groups: patients and the physicians who serve them.

Physicians need to know why a specific solution is the correct tool to unlock improved patient outcomes, and patients must understand its function so they’ll commit to using it.

I’ll explain how designing for both the patient and physician can help boost adoption rates, contribute to better health outcomes, and cut global healthcare costs by up to $3 trillion by 2030, according to a McKinsey Global Institute estimate.

7 • 2022

Start with the ‘patient problem’ Even the most miraculous digital health technology can’t improve outcomes if the patient isn’t actually using it. But driving adoption is a challenge. Despite a welldocumented rise of digital health and telehealth capabilities, the 2021 Accenture Health and Life Sciences Experience Survey found that mobile app use decreased significantly during the pandemic. (continued on page 30)

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That’s likely because those apps didn’t meet people’s needs or make their lives better. And if I were to hazard a guess, I’d say that they were developed without consulting people who would be using them. Starting each project with research and user testing helps us build empathy around user behaviors: not just what they do, but why they do it. Only when we understand that can we understand what to build.

Here’s an example. We were tasked with building a mobile app for Theragen, a wearable medical device company that developed a non-invasive stimulator to increase spine fusion surgery success rates. These types of devices often suffered from low usability (usability is key to improving outcomes), and our user research determined patients couldn’t clearly see progress over the long six-tonine months of therapy.

So we developed a streamlined interface for their mobile application that allowed patients to track usage and activity while monitoring their pain levels over time.

With better visibility into their own recovery, it became easier for patients to recognize the benefits of the therapy over time, which increased adoption rates.

Opportunity lives in the gap between what patients want or need and what currently exists. By starting the development process with an understanding of the patient, you can map toward meeting that opportunity.

Assist physicians with improving patient outcomes A physician’s primary goal is helping their patients achieve successful care outcomes quickly and at the lowest cost to the provider. That’s why telehealth has taken off since the onset of the pandemic — virtual visits let physicians see 50 to 175 times more patients than they could in person.

If you can show physicians that your digital health solution will help them treat patients in a quicker, easier, and more cost-effective manner, you’ll be the logical choice when they’re prescribing treatment.

And remember, patient and doctor pain points are often intertwined. For example, take the lack of data visibility in our example with Theragen from earlier. The ensuing application helped patients track their pain and activity on their mobile devices, and it also enabled sharing of that data with their physicians.

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Paired with increased device usability and new levels of insight into patient recovery, physicians can create personalized, data-backed care plans to further accelerate and improve patient outcomes.

Embrace the software experience as a key differentiator Medtech companies have traditionally focused on developing hardware like diagnostic equipment, pacemakers and infusion pumps. But hardware advancements can only go so far, and as a result, many medical devices are nearidentical across competing firms.

Software, along with its data collection and analysis capabilities, will become the true differentiator between the digital health companies of the future. Digital health companies need to work with physicians and patients to understand the information they need, capture it, and present it in an actionable way while providing a streamlined experience.

By staying laser-focused on addressing patient and physician pain points, digital health companies can build accompanying software that sets their devices apart from the competition.

That said, avoid the temptation to pack digital health applications with a bevy of bells and whistles that don’t tie directly to user research. Unnecessary features can frustrate patients, especially the majority of people aged 50 to 80 who have never used a health app, and cause them to quit. This hurts adoption rates and undermines the user research at the core of your digital health solution.

Theragen’s ActaStim delivers FDA-approved lumbar spine fusion therapy to promote bone growth.

Image courtesy of Theragen

Recognize the commonalities between user needs Patients and doctors want the same thing: user-friendly tech that helps patients achieve better health outcomes.

By recognizing the common objectives between the two user groups and crafting the software that helps achieve them, digital health firms can boost adoption rates and empower the best possible medical care.

"A physician's primary goal is helping their patients achieve successful care outcomes quickly and at the lowest cost to the provider. That's why telehealth has taken off since the onset of the pandemic."

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REGULATORY

How to leverage technology to drive diversity in clinical studies Convenience was the driver, and the traditional clinical trial model had to evolve when it came to a colorectal cancer screening study. The clinical study had 35,000 patients across the U.S.

C Chuanbo Xu Freenome

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Medical Design & Outsourcing

ancer doesn’t discriminate.

It’s the second-leading cause of death in the U.S. Early detection is key in treating — and even preventing — cancers like colorectal cancer (CRC).

Despite recommendations that everyone over 45 be screened for CRC, nearly a third of people don’t get screened.

This lack of screening helps make CRC the second-deadliest cancer in the U.S. For some, taking a few days off work for a colonoscopy is inconvenient. For others, the bowel preparation or stool experience can be uncomfortable or unnerving.

To improve adherence and reduce these kinds of barriers, Freenome is developing a test that’s convenient, less cumbersome and easy to administer with a standard blood draw at any doctor’s office or health clinic. With the goal of ensuring our test reaches everyone, it was critical to conduct a broad, representative study that includes everyone.

How did we reach patients of a wide variety of ages, races, ethnicities and genders? How did we ensure people in small towns and/or those without insurance

7 • 2022

Mobile phlebotomists conducted at-home blood draws for patients enrolled in Freenome’s trial.

Photo courtesy of Phleb-Finders

or access to health clinics could participate?

Convenience was the driver, and the traditional clinical trial model had to evolve.

We needed to meet patients where they were. And for many, it was online.

Going virtual When we designed PREEMPT CRC, our registrational study for a blood-based CRC screening test, it was critical that we make it easy for anyone — in any ZIP code — to participate. This means thinking through all avenues to reach multiple populations.

Virtual offerings were key. We created a dedicated website with helpful information and the ability for patients to register right there on the website.

With our physician investigators, we offered electronic consenting to make it more convenient for patients to consent online. For those patients who were not comfortable with or close to a hospital or

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other brick-and-mortar study site, we set up mobile phlebotomy teams to conduct blood draws at patients’ homes. Phone calls and email communication from the study staff provided patients with additional support and information to navigate the study process.

And it worked. PREEMPT CRC enrolled more than 35,000 people across patient ages, genders, races, ethnicities and insurance status in both rural and urban areas in every state in the continental U.S. PREEMPT CRC is representative of the real world.

Overcoming challenges Like any major operation with a lot of moving parts, we expected challenges.

However, we did not anticipate a global pandemic. PREEMPT CRC launched in May 2020 with the goal to offer convenient options for patients and support traditional study sites. As COVID-19 spread across the country, virtual options became even more important.

To reach Black and Hispanic patients in addition to underserved communities like those in rural communities or those without access to health clinics, it was important to have communication and support on the ground. Working with partners like the Colorectal Cancer Alliance (CCA), Dia de la Mujer Latina, Intercultural Center for Health Research and Wellness, historically black colleges and universities like Morehouse School of Medicine, and retail pharmacies like CVS Health’s Clinical Trial Services provided patients with the culturally competent materials and education needed to drive enrollment.

Virtual recruitment, electronic consent and mobile phlebotomy create options to reach patients outside of urban areas with teaching hospitals.

Community partners extend reach, offer trust and credibility to educate patients on the clinical study process and their role. Finally, enlisting culturally competent staff to help tailor communication to specific populations.

Let’s hope diverse clinical studies will become the norm rather than the exception in the coming months. My experience with PREEMPT CRC shows that with some key strategic steps, it’s possible.

Plan ahead and think differently for your next clinical trial If you’re planning a clinical study for any therapeutic area, think outside the traditional model and get in the mindset of patients to offer multiple avenues for education, enrollment and participation.

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COMPONENTS

Photo courtesy of Widex USA

Why filter bank design is critical for effective hearing aids The choice of filter bank is key for recreating natural sound in hearing aids.

M

Dana Helmink Widex USA

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odern hearing aids are a medical technology marvel, specifically in the area of digital audio processing.

They capture sound waves, convert them to digital signals, process them through the device, then deliver a new sound wave to the ear automatically optimized for the setting and wearer.

Digital audio processing is not new, but when it’s done through a medical device like a hearing aid, it can change lives for the better.

One in every eight Americans aged 12 and older has hearing loss in both ears, and a majority would benefit from treatment. If left unaddressed, hearing loss can contribute to significant cognitive decline, in addition to depression, anxiety and isolation.

Meanwhile, studies suggest that socialization and daily participation in everyday life — often enabled by hearing aids — boost cognitive function, helping to keep the brain stimulated.

Basically, the worse you hear, the less you participate. The less you participate, the worse for your cognitive health.

7 • 2022

The importance of signal processing: volume versus clarity For hearing aid wearers, the challenge isn’t just about hearing more (volume). It’s about hearing better (clarity). For example, if you’re in a noisy restaurant, you don’t want the noise to be louder. The best hearing aids help wearers limit background sounds so they can clearly understand the words people say. And hearing aid technology sometimes gets in the way of that clarity.

Hearing aids sound “tinny” and artificial when there’s a delay in sound processing. Most hearing aids today take 5-8 milliseconds to process sound. That may not seem like a long time, but when coupled with direct, immediate sound that enters the ear canal by passing through or around the earpiece, the resulting sound is distorted and unnatural. That’s why signal processing is so important. How long it takes and the techniques manufacturers employ can make all the difference.

Overall, most digital hearing aids process sound almost the same. A microphone picks up sound waves and converts them into a digital signal. (continued on page 36)

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COMPONENTS

An analysis filter bank splits the signal into multiple frequency bands, which can then be compressed, amplified and processed depending on the listening situation. After that, the bands are brought back together in a synthesis filter bank and that’s what’s heard through the hearing aid ear tip.

This approach underscores how important filter banks are for digital signal processing. Choosing the right filter bank is key to natural-sounding hearing aids.

"One in every eight Americans aged 12 and older has hearing loss in both ears, and a majority would benefit from treatment."

a bandwidth that is five times wider has a time resolution five times higher (faster).

Conversely, a narrower bandwidth means poorer time resolution (slower).

With frequency-domain filter banks, the width of the frequency bands is always the same. This means all bands are kept relatively narrow because bandwidth is set based on what’s needed for the lowest frequencies, where the ear’s sensitivity is highest. Because of the correlation between time and frequency, all bands operate with the same, relatively poor time resolution.

Time-domain filter banks allow manufacturers to use filters of varying widths. Therefore, product designers can set bandwidths any way they like. With the bands varying in width, so does the time resolution.

Choosing a filter bank Frequency-domain filter banks are the popular choice for hearing aid makers, and there are some convincing reasons why. But to deliver the most natural sound, those in the hearing industry should consider time-domain filter banks.

The obvious question is: What’s the difference between the two? The answer lies in time and frequency resolution. In any filter bank, the wider the frequency band, the greater the time resolution. Therefore,

Recreating real hearing What do adjustable widths mean in practice? Time-domain filter banks allow hearing aid designers to narrow bands at

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lower frequencies and broaden them at higher frequencies, resulting in the same trade-off between time and frequency as humans have in their own ears. A healthy human ear has higher frequency sensitivity at lower frequencies and lower sensitivity at higher frequencies.

Recreating human speech is a complicated endeavor. Spoken consonants are short in duration, but high and wide in frequency. Spoken vowels are longer in duration but lower and narrower in frequency. This means the sound signals would most effectively be processed by filters where the high frequencies have high time resolution while the low frequencies have better frequency resolution — something only time-domain can achieve.

Staying away from down-sampling One more thing to consider when designing a hearing aid is downsampling. Hearing aids are vital medical devices for those who wear

them. Ideally, they last all day before needing to be recharged, which means power-consuming functions like signal processing need to be kept in check.

Down-sampling can help conserve battery, but at the price of sound quality.

Frequency-domain filter banks make down-sampling straightforward because of their narrow filters. With time-domain filter banks, the benefits of down-sampling are minor and don’t outweigh the risk of diminished sound quality. Therefore, a time-domain filter bank requires other available solutions for keeping power consumption low.

But by avoiding down-sampling and preserving the original signal content, manufacturers achieve higher fidelity, lower the risk of artifacts and improve natural sound quality.

When designing a hearing aid and refining signal processing, frequencydomain filter banks may have their benefits, but a time-domain filter bank will deliver the best result for the wearer.

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TUBING TALKS

Part of the Farapulse pulsed-field ablation system, the Farawave single-shot catheter is designed to create durable and circumferential lesions.

Image courtesy of Boston Scientific

What is pulsedfield ablation?

Here's what you need to know Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston.

P

Chris Newmarker Executive Editor

ulsed-field ablation is a nonthermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation (AFib) is treated.

PFA’s roots go back to the dc ablation tech of the 1980s. These days, PFA generally involves high-voltage electric pulses from a catheter-delivered electrode or electrodes, each delivered at a tiny fraction of a second. Its potential advantages versus radiofrequency ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it, while other types of surrounding tissue are injury resistant.

It’s hard these days to find a cardiac device company that is not doing something related to PFA. At our DeviceTalks Boston conference and expo in May 2022, we were lucky enough to have a panel of executives from three of the leaders in the space: •

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Dr. Kenneth Stein is SVP and CMO of CRM at Boston Scientific, which acquired Farapulse in 2021. The Farapulse PFA treated nearly 2,000 patients in nine European countries last year. It has a CE mark, and Boston Scientific is seeking FDA clearance.

•

•

Dr. Khaldoun Tarakji is the CMO of the Cardiac Ablation Solutions operating unit at Medtronic. The medtech giant is in the process of completing a global clinical trial of its PulseSelect PFA system. It’s conducting the study in the U.S. under an FDA investigational device exemption. Medtronic also announced in January that it plans to acquire cardiac mapping and ablation technology developer Affera for nearly $1 billion. The plan is for the deal to close in the coming months.

Dr. Steven Mickelsen founded Farapulse and is presently the chief translational science officer at Acutus Medical.

The Acutus PFA system is under investigation in CE mark countries.

Here are some key takeaways from the panel, lightly edited for length and clarity: 1. PFA could be safer, faster and more effective.

Stein: “The key is that myocardial tissue is uniquely susceptible to this pulse-field energy source. And as a result, you can irreversibly damage myocardial tissue without irreversibly damaging surrounding tissues. (continued on page 40)

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TUBING TALKS

"There's a promise that ablation for atrial fibrillation is safer because you can avoid collateral damage. Because of that, you can ablate in areas a little more aggressively than you can with thermal techniques."

So there’s a promise that ablation for atrial fibrillation is safer because you can avoid collateral damage. Because of that, you can ablate in areas a little more aggressively than you can with thermal techniques. And therefore, there’s a promise that it may be more effective than conventional thermal techniques.

And then depending on the format of the catheters, the generator and the workflow, it clearly can be much faster than conventional energy sources. There are very few times in medicine, engineering or life where you ever get that trifecta of safer, more effective and faster. As long as we can prove out in clinical trials that it lives up to that promise, it will revolutionize ablation therapy.”

Tarakji: “I think the combination of durable lesions, effective therapy — at the same time achieving safety — that’s probably the main driver for the excitement in the EP [electrophysiology] community for pulsed-field ablation.”

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2. There are a lot of variables around PFA, and it’s going to take time to prove results.

Mickelsen: “The field right now is very full with a lot of different strategies or recipes for pulse field. With RF — an oscillating wave where you get heating and it’s predictable — there’s a pretty narrow kind of bandwidth used universally throughout the field. But with PFA, there are a lot of options. That recipe can be a whole bunch of different engineering ways of playing with the knobs.

And what I’m hoping to see is over the next five to 10 years is a convergence on what recipe works best for the heart.”

Stein: “Every RF lesion in any catheter — if it’s the same sized catheter tip and the same back patch, it’s the same lesion. PFA is very much dependent on the particular waveform, the particular energy source and the particular workflow. And one of the things to watch out if you’re trying to create your own PFA startup is to remember the

SVP and CMO of CRM at Boston Scientific Dr. Kenneth Stein

biophysics. The irreversible field of injury — that is always surrounded by a large field of reversible electroporation. One of the things you learn really fast when you start doing this is you’ve got to try really hard to get bad acute results with

CMO of the Cardiac Ablation Solutions operating unit at Medtronic Dr. Khaldoun Tarakji

Farapulse founder and Chief Translational Science Officer at Acutus Medical Dr. Steven Mickelsen

PFA. It always looks great acute, because even if you haven’t been irreversible, you’ve got a reversible field. And so the proof of the pudding isn’t until you do three-month remaps, or you wait and look at your one-year chronic results. >>

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TUBING TALKS

It’s very easy to fool yourself early. That’s part of why the development path for the Iowa Approach, which became Farapulse, took too long. And then the second thing I’d say, which was one of the things that I think Farapulse did really well, is not just taking an RF catheter and trying to push PFA through it. Actually design a catheter from the ground up to use this energy source. You can put wings on a boat and tell people to fly it, but you don’t want to be a passenger in that airplane.”

3. There are different approaches.

Mickelsen: “What Acutus is looking at is that we need a flexible format that really highlights our ability to see and map AFib in real-time and choose targets based on that. And so one-size-fits-all didn’t necessarily meet the strategy of the company. That’s why we went with a point-by-point version of PFA. But I think every single company that’s in the space is going to have at least some offering that is a single shot, very simple, that doesn’t require the technical skills of moving around a deflectable catheter and the atrium for the purposes of a [pulmonary vein antrum isolation] tool. And then I think every one of the players in the field is also going to have a point-by-point offering because even if you do all your AFib ablation, you still have 50% of all ablations done on Earth that are not AFib.”

Stein: “No one goes out to play golf with just a single club in their bag, unless it’s me playing miniature golf. Ablation takes a lot more than just that. There is a question of integration with 3D. We have anatomic mapping systems, there’s the issue of transeptal access. We’re really excited about the technology that Baylis Medical [acquired by Boston Scientific for $1.75 billion] brought to us in terms of transeptal crossing. It can also come to what other things does a patient need? Do they need left atrial appendage closure with something like the Watchman device? We as a company try to look at ourselves as not just providing widgets for people who need widgets to treat their patients, but to really provide a comprehensive toolset for

the overall management for patients with atrial fibrillation.”

4. There’s still a need for innovation.

Stein: “If someone had a way of knowing they can interrogate and tell whether tissue is reversibly versus irreversibly electroporated, that would advance the field substantially.”

Tarakji: “You can achieve electrical silence, but that doesn’t give you the confidence of whether it’s going to be reversible or not. … Defining electrical silence, that’s easy. You put your catheter in, you can see that. But what’s reversible, what’s not? I agree, there’s still a lack of ability to do this.”

Image courtesy of Boston Scientific

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How Stryker includes users for product design in the digital age

Jim Hammerand | Managing Editor |

“We don’t write a single line of code until we’ve talked with doctors and nurses to get the experience right,” Stryker SVP Dave Lively said.

M

edical device developers and manufacturers like Stryker are changing how they approach design as digital technology becomes more crucial.

Four Stryker executives shared how the Kalamazoo, Michigan–based orthopedic device giant is thinking differently about medical product development and how health care providers and patients will ultimately use them.

The DeviceTalks Boston panel of Stryker executives was moderated by Stryker Orthopaedics and Spine Group President Spencer Stiles. The following has been lightly edited for space and clarity.

VP of Digital at Stryker Tracy Robertson 44

Medical Design & Outsourcing

Digital VP Tracy Robertson: We’re living in what’s called “The Age of the Customer.” Forrester Research termed that about 12-plus years ago. It started in retail and went through every industry. It’s now 7 • 2022

affecting [our] industry and transitioning into this industry in a major way. What’s happening is people are bringing their experiences — you’re doing it as well — from home to work: “If I can click this at home, why can’t I do that at work?” And you’re expecting that from your vendors at work, you just want brainless transactions.

You want everything the same way at home as you do at work. And we have not been able to solve that or crack that at work, but that is the expectation. It has drastically changed. Experience is now a top purchasing criteria, almost at the same level as the product or service itself. So that is a huge challenge for companies.

CX — customer experience — has now evolved into what we call the business of experience. We have to think about customers, our consumers, our patients, our ecosystem of customers, in how we design the product. Design, the product,

www.medicaldesignandoutsourcing.com

the brand experience, our employees, their experience and the customer, it’s all integrated now. It’s a huge burden for us, but we’re competing against all of those things. It’s not just the product. I share all of that with you because in digital, you cannot separate experience from digital.

For example, we can create all of these great products for our customers and create great data. And when we go to present it to our customers, if it’s hard to digest or it’s hard to interpret, it’s not a gift for them. It’s more work. There are a lot of adoption challenges in digital. So again, we can’t separate experience from digital, and that has to be part of the experience.

That has to be a big part of how we start to design and think for our customers in the future. Otherwise we’ll have adoption challenges.

SVP of Product Management at Vocera (now part of Stryker) Dave Lively

VP of Digital Innovation for the Surgical Technologies business at Stryker Siddarth Satish

Dave Lively, SVP of product management, Vocera (now part of Stryker): We don’t write a single line of code until we’ve talked with doctors and nurses to get the experience right. And so we focus a lot on user-centered design.

As soon as we’ve observed the problem or heard about a challenge from nurses and doctors, we’ll come back immediately with mockups: Does this address it?

Does this address it? We’ll go through multiple iterations around the design of particular piece of software or a screen or a voice user interface to make sure that it’s solving the problem that the nurses and the doctors are having. Once we get that right — you can do a lot with just mockups and just design — then we’ll start writing the code. And then even after we write the code: Test it again, test it again, test it again. That human factors process has to start at the absolute beginning.

Surgical Technologies VP of Digital Innovation Siddarth Satish: Focus on UI/ UX (user interface and user experience) is paramount. With our product, we’re literally asking nurses in the middle of an OR to hold a bloody sponge up to an iPad and open it up. Think about that for a second. There’s a million things going on, it’s tough to do. We not only worked through that iterative cycle, we had to build and formalize human factors testing as part of our pathway through FDA. The agency has started to focus more and more and more on human factors.

We’re seeing that a lot in these newer digital health technologies and during www.medicaldesignandoutsourcing.com

the pandemic through the EUA process with those at-home COVID test kits. It’s a really big deal. So we standardize and protocolize a lot of that. It’s built into every release cycle, even if we’re pushing a few lines of code, a small fix, there’s the question, “Does this qualify for a concerted test with, let’s say, 20 nurses to validate what we’ve done?”

Digital, Robotics, and Enabling Technologies President Robert Cohen: Human factors is part of all the Stryker efforts going forward. In fact, we’ve created panels for the human factors. In the old days, we’d get physicians coming to a cadaver lab when we were done. Now on our enabling tech — whether it’s software, things like that — workflow matters, efficiency matters, shortening the learning curve, what training cycle needs to be, what needs to be included in certification.

So let’s just take a new robotics software for a new application. We get nurses involved. We’ve built OR simulation labs.

We just built one in our new facility in Fort Lauderdale where we monitor behind glass. We have physicians, we have people in central supply that do cleaning of instruments and how to put things back.

We’re labeling everything. So human factors and then usability is now included in all regulatory silos around the world.

Read more from Styker executives as they discuss trends in medtech at www.wtwh.me/bYH

President of Stryker’s Digital, Robotics, and Enabling Technologies organization Robert Cohen 7 • 2022

Medical Design & Outsourcing

45

can’t explain drop in device recalls, but experts point to COVID disruption The FDA acknowledged interruptions with

DAN I ELLE KI RSH SEN I OR EDI TOR

notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures.

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www.medicaldesignandoutsourcing.com

FDA

medical device product recalls dropped last year to their lowest level since 2013, according to a Medical Design & Outsourcing analysis of recall data from the regulatory agency.

Medtech regulatory experts said the COVID-19 pandemic showed room for improvement in FDA oversight and postmarket surveillance of medical devices.

Device products recalled in fiscal year 2021 (ended Sept. 30, 2021) totaled 2,607, a 14.3% decrease from the 3,042 recalls reported in fiscal 2020.

The drop in device recalls occurred at the same time the FDA put more emphasis on fighting the COVID-19 pandemic and improving device safety protocols, according to FDA’s Center for Devices and Radiological Health (CDRH) annual report.

CDRH Director Dr. Jeff Shuren said in September that the agency was “starting

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to turn the corner” on catching up on premarket approval applications and 510(k) clearance submissions, after having focused on the pandemic and issuing emergency use authorizations (EUA) in record time.

The 2,607 product recalls from last year are the fewest since fiscal 2013, when device companies had 2,304 recalls. Fiscal 2013 was the first full year for which the FDA made these tallies public. The agency reported its highest number of recalls, at 3,285, in fiscal 2018.

In fiscal 2021, Class I recalls dipped 1.2% to 169, Class II recalls decreased 15% to 2,389 and Class III recalls dropped 19.7% to 49.

The largest year-over-year change of any year and any class since FDA started reporting these numbers was in fiscal 2019 — the last full year before the COVID-19 pandemic — when Class I recalls more than tripled. That year, there were 370 Class I recalls (up 216.24%), 2,376 Class II recalls (down 23.5%) and 97 Class III recalls (up 43%).

Medical device recalls may have been down last year. But the time period also saw one of the most serious industry recalls in years: Class I recalls involved millions of Philips Respironics ventilators, CPAPs and BiPAPs with dangerous sound abatement foam. The FDA received more than 21,000 medical device reports and 124 reports of deaths between April 2021 and April 30, 2022. >>

7 • 2022

Medical Design & Outsourcing

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FDA RECALLS

"The number of devices recalled in a year is not an indicator of the safety of marketed devices generally and is not a metric that can be analyzed as a trend."

The agency ordered the Amsterdambased company to submit a plan for repairs, replacements or refunds of respiratory devices with the faulty foam.

After inspecting a manufacturing facility connected to the recall, the FDA said Philips has known about problems with the foam since 2015. Philips is no longer taking orders of the sleep therapy systems and said it is cooperating with the FDA as well as the U.S. Department of Justice, which subpoenaed the company for information related to the recall.

FDA spokesperson Jim McKinney told MDO that the FDA could not say with certainty what’s behind the reduction in device recalls and recall events in fiscal 2021.

“The number of devices recalled in a year is not an indicator of the safety of marketed devices generally and is not a metric that can be analyzed as a trend,” he said in an email.

McKinney said the pandemic “has not changed the FDA’s critical oversight role to protect and promote public health by ensuring medical devices are safe and effective,” but acknowledged COVID disruption.

BD’s Alaris infusion pump and vital signs monitoring system is designed to deliver controlled amounts of fluid, medication, blood and blood products.

Photo courtesy of BD

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“We have seen some interruptions with notification and reporting to the FDA and implementation of mitigation efforts on behalf of some firms with active recalls,” McKinney said. “The FDA continues to actively work with these firms to address such recalls and implement mitigation efforts as soon as possible.”

FDA regulates over 190,000 different devices manufactured by more than 18,000 firms across the world. Since the beginning of the pandemic, the FDA’s CDRH granted EUA or full marketing authorization for more than 2,000 medical devices specifically designed for COVID-19 treatment, detection and diagnosis.

With a greater focus on the pandemic, there were fewer inspections, and those that took place were virtual, for the most part.

“This leads to potentially all kinds of issues on the manufacturing, reliability and quality side,” said Michael Drues, a regulatory consultant for medical device companies and the FDA. He warned against drawing conclusions from the low recall numbers — or celebrating them.

“Just because people are not reporting doesn’t necessarily mean that there aren’t problems,” Drues said. “Lawsuits against medical device companies is probably a much better surrogate biomarker or prognostic indicator of how this industry is doing.”

‘Maybe we just had a good year’ Starting in March 2020, the Centers for Medicare and Medicaid Services (CMS) recommended postponing elective procedures to preserve personal protective equipment. CMS later relaxed the guidelines, but critical care for patients in the delta and omicron variant waves further delayed scheduled procedures and hurt sales of many medical devices.

That could have contributed to fewer recalls, said Canyon Labs Chief Clinical Research Officer Dr. David Locke, a regulatory science program instructor at Johns Hopkins University who was previously a regulatory affairs professional at Johnson & Johnson.

“Maybe we just had a good year where products functioned well,” Locke said. “Or maybe not as many were used.”

Device manufacturers, physicians and patients are responsible for reporting issues to the FDA. (continued on page 50)

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FDA RECALLS

This chart shows the number of products recalled each fiscal year, broken down into Class I, Class II and Class III classifications. Class I is the most serious level of health hazard.

If an issue is severe enough for a company to initiate a recall, the agency will collaborate with the recalling firm to weigh the risk of a device against the benefits. It’s not always an easy call.

"It's up to the FDA as well as the company, the product liability attorneys and the physicians and the patients, and everybody else to try to figure out where that compromise is,” said Drues.

Making the difficult call Some devices may have stayed on the market longer than they should have due to a fear of shortages in healthcare facilities during the pandemic, said Madris Kinard, the founder and CEO of Device Events and a former unique device identification (UDI) external program manager and adverse events SME for medical devices at the FDA. "The companies are making these decisions, and then the FDA might review them, but isn't necessarily taking an active enough approach,” Kinard said.

One example of a device that would have likely caused shortages in hospitals if recalled is BD’s Alaris pumps. In March 2020, the FDA called for a comprehensive 510(k) submission after BD recalled hundreds of thousands of Alaris pumps due to system-, software- and use-related errors. The pumps continued to face a series of Class I recalls until April 2021. As of publication, BD still had new shipments of the pumps on hold in the U.S. as it awaits the results of a required 510(k) clearance submission it made to FDA last year.

“They didn't want to pull them for the software update if they were being used on a patient. And of course, with COVID going on, they probably were all in use,” Kinard said.

In another serious device recall last year, Medtronic’s HeartWare Ventricular Assist Device (HVAD) system was designed as a bridge to cardiac transplants in patients who were at risk of death from end-stage left ventricular heart failure, for heart tissue recovery or as destination therapy in patients who cannot receive heart transplants.

The Fridley, Minnesota-based medtech giant began recalling the HVAD 50

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Medical device recalls by fiscal year Class I Class II Class III

3500

3000

2500

2000

1500

1000

500

0 2013

2014

2015

2016

2017

2018

2019 2020 2021 Source: FDA Data Dashboard

YEAR

# RECALLS

CLASS I

CLASS II

CLASS III

2013

2,304

185

1,988

131

2014

2,706

360

2,294

52

2015

2,850

287

2,494

69

2016

2,900

111

2,673

116

2017

3,225

64

3,076

85

2018

3,285

117

3,100

68

2019

2,843

370

2,376

97

2020

3,042

171

2,810

61

2021

2,607

169

2,389

49

TOTAL

25,762

1,834

23,200

728

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FDA RECALLS

pump implant kits in March 2021 and later stopped sales and implantations of the device altogether due to an increased risk of serious injury or death, yielding the market to Abbott’s competing technology.

When Medtronic stopped selling the HVAD in June 2021, it reported over 100 complaints involving a delay or failure to restart the HVAD internal pump, which led to 14 deaths and 13 pump removals.

The medtech giant continues this year to work through Class I level recalls related to the device.

“I think the BD Alaris pumps and the HVAD are good examples of why recalls should be mandatory, because they postponed them,” Kinard said. “And if the FDA agrees because of COVID reasons, or if there's something else, if it's going to cause a market shortage. Of course, with the HVAD, it didn't because there was another company that was better able to service those patients anyway.”

Medtronic’s discontinued HVAD system pumps blood from the heart to the rest of the body.

Photo courtesy of Medtronic

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The Dexcom G6 CGM product family Photo courtesy of Dexcom

With the G7 nearing FDA clearance, Dexcom leadership foresees major innovations for integrated automated insulin delivery down the line.

SEA N W H O O LEY A SSO C IATE ED ITO R

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K

evin Sayer began thinking about automated insulin delivery all the way back in 1994 when he was working at MiniMed. Nearly 30 years later, as CEO of Dexcom, that space continues to pique his interest.

In the '90s, MiniMed ran trials with a fully implantable system before Medtronic bought the company. Sayer admits the system with an implantable pump and sensor wasn't particularly practical, but it planted the seeds for what could grow.

Now with Dexcom, the maker of the leading G6 continuous glucose monitoring (CGM) system — and the next-generation G7, which is expected to receive FDA clearance www.medicaldesignandoutsourcing.com

soon — Sayer has seen the integration of CGM with automated insulin delivery through partnerships with Insulet and Tandem Diabetes Care. He believes room for growth remains, with pump penetration not yet passing 50% of intensive insulin users.

"I've been around the fringes of this for a very long time," Sayer told Drug Delivery Business News during the American Diabetes Association (ADA) Scientific Sessions in June.

"I've often asked myself the question, 'How big does this get?' The feedback I'm hearing from users of both Tandem's system and [Insulet's] Omnipod 5 is incredibly positive. (continued on page 54)

DEXCOM ‘SCIENCE BOOM’

The Dexcom G7 continuous glucose monitor Photo courtesy of Dexcom

I think this is going to be a very important part of our business going forward."

Sayer said G7 offers an even better opportunity over time because it is 60% smaller than the G6, which "decreases the amount of real estate on the body."

Once it garners FDA clearance, the integration into Tandem's and Insulet's systems will further highlight the benefits of the next-generation CGM. Dexcom owns the algorithm that represents the basis of Tandem's t:slim X2 insulin pump. Sayer said he sees the analytics angle as a "bright" future component of what the company does.

Dexcom has to incorporate artificial intelligence algorithms with data collected from its technology to find new and improved ways to help people manage their diabetes, he said.

"I think you'll see a science boom over the next 10 years with this stuff," Sayer said. "It can give people opportunities to pretty much get out of their diabetes care and let systems do it.

Right now, we're not there, and there'll be a lot of trials and a lot of pain.

"So, then, how does Dexcom play into this? The most important element is giving somebody an accurate glucose reading that is communicated on a timely basis. The second-most-important element is an algorithm that can drive that outcome, and we've got access to both, and we've got partners who can use it.

We're very excited about the future here."

Recent rumors put Dexcom in the mix to enter the automated insulin delivery space itself, with Bloomberg 54

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reporting that the company was in talks to acquire Insulet.

Suggestions of a merger between the two diabetes tech giants were quickly put to rest when Dexcom issued a statement saying it is not in active discussions regarding any such transaction.

The company said it did not intend to comment further on the matter, and Sayer declined to offer a comment a week after.

"Our focus will be on supporting our partners and helping the technologies that can best serve that space," he said.

G7 excitement Plenty of focus remains on Dexcom's next-generation G7, which could be picking up FDA clearance any day now.

Sayer earlier this year said clearance may come after ADA. "It's a give and take, back and forth, and the FDA has been very involved with us in discussions," Sayer said as ADA came to a close last month. "Would we like to be in all these discussions? No. Would we like to be done? Absolutely. But, we understand that, if they're going to grant us all-iCGM status where we're integrated with insulin delivery systems, they're entitled to ask a bunch of questions, because people's lives depend on this."

The platform features a nearly two-thirds size reduction, a 30-minute warmup period (down from waiting two hours for glucose readings to begin in the past) that offers reliable data after just that half-hour period, more information in one place with personalized insights, extended-wear design and more.

Over Zoom, Sayer demonstrated the simplicity of the G7 experience, with the process containing very few steps.

He opened a box, unscrewed a cap and showed that all the user has to do is place the apparatus on their body and push a button to apply the sensor.

The Dexcom One

Photo courtesy of Dexcom

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DEXCOM ‘SCIENCE BOOM’

"Everybody who's on it, they're never going back to what they had before," Sayer said. "Nobody's going back to G6. Nobody's going back to wearing no sensor. They absolutely love it. I think it'll be a wonderful product for us."

Dexcom's expanded portfolio G7 isn't the only exciting technology at Dexcom, as Jake Leach, the company's chief technology officer, told Drug Delivery Business News in April.

“We are producing a portfolio of products,” Leach said. “We’re differentiating our portfolio."

Sayer echoed Leach's sentiment, pointing to the launch of Dexcom One — an easy-to-use, real-time CGM (rt-CGM) that it aims to make more affordable and accessible with a wearable sensor and transmitter to continuously monitor glucose levels and send real-time values wirelessly to a compatible smart device

via the Dexcom One mobile app.

Dexcom One was recently launched in the United Kingdom, and Sayer said there's a coming launch in Spain, too.

The company also received FDA breakthrough device designation for the use of CGMs in hospitals. Sayer said they've assembled a team that features hospital device experience so Dexcom will be ready for full approval.

And while clearance for G7 looms, G6 is still performing at a high level, with one study presented at ADA highlighting users in Belgium who switched from Abbott's FreeStyle Libre to Dexcom's G6 and experienced marked improvement over three years, Sayer noted.

Analysts are optimistic about Dexcom and its upcoming offerings.

BTIG’s Marie Thiabult wrote that the company is experiencing strong adoption trends as the introduction of G7 in the U.K. is “going well.”

The Dexcom G6 (left) compared to the G7 (right) Photo courtesy of Dexcom

“Underlying business indicators are stable,” Thibault said. “We remain bullish on long-term, broad-based growth for CGM adoption.”

Sayer agrees.

"Everywhere I walk [at ADA] and everybody I talk to, Dexcom has become part of their company, part of their lives," Sayer said. "We really are dialed in here and have made a lot of progress. I think the future looks amazing."

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THE 50 LARGEST PHARMA COMPANIES The pandemic highlighted the potential of new R&D strategies for drug developers.

B R IA N B U NTZ P H A R MA ED ITO R

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7 • 2022

2021

was a bright year for many pharmaceutical firms, especially those able to find widespread support for their COVID-19 vaccines and therapies.

But it would be wrong to take a myopic view of the pandemic as a chief growth driver for leading drug developers.

The most significant impact of the pandemic may be how it changed R&D rather than how it drove sales in 2021.

Three companies rounding out the top five — including the Chinese conglomerate Sinopharm, AbbVie and Novartis — didn’t have material COVID-19-related sales in 2021. The same holds for the bulk of companies in this year’s Pharma 50

report, which ranks the industry’s leading companies by overall revenue.

The pandemic has, however, given companies like Pfizer extra cash to plow into acquisitions. In March, the company finalized its $6.7 billion acquisition of Arena Pharmaceuticals, a developer of immuno-inflammatory drugs. Two months later, Pfizer announced it planned to acquire migraine therapy maker Biohaven for roughly $11.6 billion.

M&A activity cooled in the early days of the pandemic but began to recover in 2021. The biggest acquisition last year was Jazz Pharmaceuticals’ $7.2 billion acquisition of GW Pharmaceuticals. (continued on page 58)

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The next-biggest deal was Sanofi’s purchase of Translate Bio for $3.2 billion.

Sizable acquisitions are nothing new for the industry as the average return on R&D spending has floundered.

But the pandemic helped change that expectation, underscoring how companies that succeed in swiftly forging R&D partnerships and developing new

therapies for unmet medical needs can reap handsome rewards.

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of the most popular vaccines in 2021, the platform’s potential in other infectious diseases and oncology remains unproven.

Before COVID-19, the industry largely struggled to see significant returns on R&D investments and looked for acquisitions to secure growth.

However, pharma will likely need a more sophisticated strategy going forward.

THE 50 LARGEST PHARMA COMPANIES RANK

58

COMPANY

HEADQUARTERS

2021 REVENUES ($USD)

1

Pfizer

United States

$81,288,000,000

2

Sinopharm (pharmaceutical distribution segment)

China

$60,450,609,227

3

AbbVie

United States

$56,197,000,000

4

Janssen (Johnson & Johnson’s pharmaceutical segment)

United States

$52,080,000,000

5

Novartis

Switzerland

$51,626,000,000

6

Roche Pharmaceuticals (division of Roche Group)

Switzerland

$49,257,436,570

7

Merck & Co.

United States

$48,704,000,000

8

GlaxoSmithKline (GSK) (minus consumer segment)

United Kingdom

$46,940,864,000

9

Bristol Myers Squibb

United States

$46,385,000,000

10

Sanofi

France

$44,557,980,000

11

AstraZeneca

United Kingdom

$37,417,000,000

12

Thermo Fisher Scientific (Life Sciences Solutions + Laboratory Products and Biopharma Services)

United States

$30,493,000,000

13

Takeda Pharmaceutical

Japan

$29,113,364,894

14

Eli Lilly

United States

$28,318,400,000

15

Gilead Sciences

United States

$27,305,000,000

16

Amgen

United States

$25,979,000,000

17

Boehringer Ingelheim

Germany

$24,391,094,000

18

BioNTech

Germany

$22,449,436,100

19

Novo Nordisk

Denmark

$22,420,382,166

20

Bayer (Pharmaceuticals Division)

Germany

$21,651,820,000

21

Sinovac

China

$19,400,000,000

22

Merck KGaA, Darmstadt, Germany (life sciences plus healthcare revenue)

Germany

$18,973,220,000

23

Moderna

United States

$18,471,000,000

24

Viatris

United States

$17,813,600,000

25

Regeneron Pharmaceuticals

United States

$16,071,700,000

Medical Design & Outsourcing

7 • 2022

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PHARMA50

See the full report at wtwh.me/c27

THE 50 LARGEST PHARMA COMPANIES THE WORLD

THE 50 LARGEST PHARMA COMPANIES RANK

COMPANY

HEADQUARTERS

2021 REVENUES ($USD)

26

Teva Pharmaceutical Industries

Israel

$15,878,000,000

27

Astellas Pharma

Japan

$11,375,892,207

28

Biogen

United States

$10,981,700,000

29

CSL, including CSL Behring

Australia

$10,310,000,000

30

Daiichi Sankyo

Japan

$9,512,855,062

31

Chugai Pharmaceutical (Roche Group)

Japan

$9,101,957,393

32

Otsuka Holdings (pharmaceutical business)

Japan

$8,899,380,918

33

Bausch Health

Canada

$8,434,000,000

34

Vertex Pharmaceuticals

United States

$7,573,000,000

35

UCB

Belgium

$6,816,860,000

36

Organon

United States

$6,304,000,000

37

Lonza

Switzerland

$5,915,354,331

38

Eisai

Japan

$5,880,371,449

39

Grifols

Spain

$5,821,079,240

40

Servier

France

$5,575,500,000

41

Abbott (Established Pharmaceutical Products)

United States

$4,718,000,000

42

Sumitomo Dainippon Pharma

Japan

$4,697,305,171

43

Sun Pharmaceutical Industries

India

$4,530,743,855

44

Sino Biopharmaceutical

China

$4,164,034,848

45

Catalent

United States

$3,998,000,000

46

WuXi AppTec

China

$3,550,317,030

47

Ipsen

France

$3,385,302,000

48

Aurobindo Pharma

India

$3,350,857,712

49

Kyowa Kirin

Japan

$3,206,900,947

50

Jazz Pharmaceuticals

Ireland

$3,094,238,000

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7 • 2022

Medical Design & Outsourcing

59

DEVICETALKS

THEY SAID IT

at DEVICETALKS Boston

Medical device industry leaders from Boston Scientific, Medtronic, Stryker, Insulet and more met up in Boston to share their perspectives on industry trends, device design and innovation.

Jim Hammerand | Managing Editor | Chris Newmarker | Executive Editor | Sean Whooley | Associate Editor |

M NADINE HACHACH-HARAM PROXIME

SIDDARTH SATISH STRYKER 60

edtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead. Here are some of the most quotable insights from panelists and speakers at our live event.

Go to wtwh.me/dtb to read more team coverage from DeviceTalks Boston.

And make sure to save the date — and save your seat — for DeviceTalks West in Santa Clara, California on Oct. 19 and 20. Learn more about the lineup and register at west.devicetalks.com.

TECHNOLOGY With all the hype around the use of data, artificial intelligence (AI) and other technologies, the operating room environment is ever-changing.

Panelists discussed how it translates to what clinicians do in practice, and how it will improve: “The quality of care has improved access, but how does it ultimately make sure every patient is getting the best care the first time, every time?”

Proximie CEO Nadine HachachHaram said. “With that in mind, value

Medical Design & Outsourcing

7 • 2022

and impact was always front of mind. … We recognized that we needed to build something fit for now that fit for the future as well.”

“I really think that the AI can start to build these autonomous feedback loops into care where you don’t necessarily need to rely on someone’s expertise,” Stryker VP of Digital Innovation for Surgical Technologies Siddarth Satish said. “You can automate steps of a robotic procedure or something like a critical piece of information that that is then going to drive these protocols.”

“Pulling data back into the operating room requires that you have the capability to do that,” Avail Medsystems CEO Daniel Hawkins said. “We’re building that capability as a background network engine, but that’s really where the power of that data is — to clinically drive decision making in the moment.”

“Data is only as good as the insights that are derived from it,” Activ Surgical CEO Todd Usen said. “And because data is a bumper sticker in terms of how important it is in medicine, at the end of the day, it has to be something that’s really needed. … (continued on page 62)

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Let’s make sure we put on the screens for our surgeons the information that’s pertinent from experts around the world right at this point of care. That’s when data will mean something.”

DAVID NEUSTAEDTER MEDTRONIC

FRANK J. DOYLE III HARVARD

VENTURE CAPITAL David Neustaedter, VP of venture capital at Medtronic, discussed how the COVID-19 pandemic’s challenges accelerated trends that influence how Medtronic views potential investments: “Payers, physicians, all the stakeholders that we care about had to become a little more flexible, and some of that flexibility is likely to pass the test of time. So that’s tremendous in that regard,” he said. “I think there are some other challenges that look to persist. For example, we see a lot of staffing issues. It’s really slowing things down. … [There’s a] move toward more information captured, whether it’s remotely or acutely and being able to be accessed and the ability, for example, to modulate therapeutic dose or call a patient in early, just like you would a BMW with a loose fan belt these days. And I think there’s a lot more predictive and information capability being added into almost every device that’s implanted and some of the devices that can be used intraoperatively.”

EDUCATION Frank J. Doyle III, dean of Harvard’s John A. Paulson School of Engineering and Applied Sciences, on the Harvard Enterprise Research Campus project opening as soon as 2024 with around 1 million square feet of leasable tech space, housing and a conference center in the first phase: “The idea is to have startups in there, have outposts of big companies, have VCs in there, create an ecosystem so that we can really have a rich, collaborative environment adjacent to engineering across the street from Harvard Business School. It’s the perfect setting for the next big innovation.”

INNOVATION Boston Scientific SVP of Urology and Pelvic Health Meghan Scanlon offered advice on innovating in the vital early stages of product development: “Early on, have a strong hypothesis for what your value proposition is going to

62

Medical Design & Outsourcing

7 • 2022

be,” she said. “But don’t go etch it in stone tablets. Use a pencil or an erasable marker and constantly test and validate it. Have an understanding of what your evidence generation plan is going to be over time, and don’t let the pursuit of perfection be the enemy of progress.”

PRODUCT DEVELOPMENT Medtronic Senior Engineering Director of Surgical Robotics Bill Peine offered a window into the development process for the Hugo robot-assisted surgery system: “We had a very clear definition of what a surgical robot was.

But, how do you build one yourself?

The way we did it was, we assembled the right team,” Peine explained.

“A surgical robot is multidisciplinary.

You have to get your architecture right, there’s a lot of mechanical and electrical design, but human factors and the user interfaces are just as critical and important.” Medtronic employed a “spiral development” process with repeated cycles of quick prototyping and customer evaluation, he said. “Most importantly, the engineering team loved this,” Peine said. “It was so much fun for them because they got to do something quick, and they were participating, getting that market feedback from customers. The R&D team has partnered very closely with the marketing team, so it was fast-paced, and at the end of a cycle, all the different subsystems would integrate their products or their individual parts into the working system.”

MEGHAN SCANLON BOSTON SCIENTIFIC

BILL PEINE MEDTRONIC

"There's a lot more predictive and information capability being added into almost every device that's implanted and some of the devices that can be used intraoperatively."

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Images courtesy of DermaSensor

PAUL GRAND MEDTECH INNOVATOR

CODY SIMMONS DERMASENSOR

MEDTECH INNOVATOR MedTech Innovator CEO Paul Grand on DermaSensor’s win at the MedTech Innovator Mid-Stage Companies Pitch Event at DeviceTalks Boston: “Our expert evaluators were enthusiastic about DermaSensor’s ability to enable earlier detection of skin cancer and improve equity of access to diagnostics via primary care providers while addressing the shortage of dermatologists and long wait times for referrals.”

DermaSensor CEO Cody Simmons: “With the benefit of their support and resources, we’ll be even better positioned to get our breakthrough product in the hands of physicians and their patients.”

DIABETES CARE Insulet EVP of Innovation and Strategy Eric Benjamin discussed the new Omnipod 5 automated insulin delivery system and the future of diabetes care: “Two huge sources of burden — thinking about what’s going to happen to blood

sugar and the need to take out and carry a separate device — that’s automated with Omnipod 5. It’s truly extraordinary technology. The feedback in our first few months of the launch has been extraordinary. … It is definitely a platform that we will build on. If you zoom way out, Omnipod 5 is a microcosm of what we think the world is going to look like 20 or 30 years from now with true, personalized delivery for a range of drugs in response to biomarkers that are detected via novel sensors to get therapy just right.” Benjamin said Insulet engineers simulate use to determine what needs to change with each version of Omnipod. “They see when things work better or less well — they experience it,” Benjamin said. It’s a huge help in providing empathy for what users are going to experience. It’s a huge part of understanding the design that they’re working on, and it’s a huge part of providing context. … That’s probably the single most important thing that we do very early in development.”

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7 • 2022

ERIC BENJAMIN INSULET

Medical Design & Outsourcing

63

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