Medical Design & Outsourcing — JULY 2021

www.medicaldesignandoutsourcing.com JULY 2021

CONTRACT MANUFACTURERS FUEL MEDTECH EXPANSION IN

a c i R a Cost

HOW CONTRACT MANUFACTURER MINNETRONIX DECIDED TO MAKE ITS OWN MEDICAL DEVICE

THIS IMAGING DEVICE COULD BE A BREAKTHROUGH FOR BREAST CANCER TREATMENT

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www.medicaldesignandoutsourcing.com JULY 2021

CONTRACT MANUFACTURERS FUEL MEDTECH EXPANSION IN

a c i R a Cost

HOW CONTRACT MANUFACTURER MINNETRONIX DECIDED TO MAKE ITS OWN MEDICAL DEVICE

THIS IMAGING DEVICE COULD BE A BREAKTHROUGH FOR BREAST CANCER TREATMENT

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JULY 20 @ 4pm – Advancements in Venting Membranes in the medtech world

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

PRODUCTION SERVICES Customer Service Manager Stephanie Hulett shulett@wtwhmedia.com Customer Service Rep Tracy Powers tpowers@wtwhmedia.com Customer Service Rep JoAnn Martin jmartin@wtwhmedia.com Customer Service Rep Renee Massey-Linston renee@wtwhmedia.com

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JULY 13 @ 4pm – Overcoming Product Development Barriers

JULY 29 @ 4pm – Complex Catheter Delivery Systems: Evaluating different design and manufacturing methods and the effects to key performance drivers

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

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s the summer sun shines upon us, we’re getting a clearer view of the outlines of the post-pandemic world in the medtech supplier space. What we’re seeing is an industry valuing three qualities — bigger, closer and different.

I say bigger because, well, the suppliers are simply larger. Writing this editorial in late June, I just finished posting an article about how private equity firm Summit Partners has acquired Ximedica, Quartesian and Boston Healthcare Associates — rolling them into a new medtech service giant called Veranex. (And we’re beginning to hear the same thing is happening in product development firms as well. Check out Delve and Bresslergroup.)

We’re seeing an acceleration of an M&A trend from the last couple of years. Following a flurry of mergers, we can name many company names that didn’t exist a decade ago: Integer, Spectrum Plastics Group, and so much more. I suspect Veranex will not be the last name added to the list.

Next to size, proximity also matters. The pandemic taught manufacturers a hard lesson about the fragility of global supply chains, something they were already considering amid the U.S.-China trade war of recent years. The situation has them looking closer to home for lower-cost manufacturing locations.

This issue’s cover story is about an increasingly popular location for medtech suppliers to set up shop: Costa Rica. The Central American country sits in the same time zone as parts the U.S., it’s stable, and it boasts a healthy, educated workforce.

With apologies to Apple, contract manufacters also are beginning to think – and act - different.

Chris Newmarker Our DeviceTalks editorial director Tom Salemi, Executive Editor for example, writes about how executives at St. Paul, Medical Design & Minn.–based Minnetronix Medical looked to fill midOutsourcing market gaps by creating their own medical devices, first c n e wm a rk e r@ wtwh m e di a .c o m in the neurovascular space.

As you’ll read, the company’s CEO says the process not only provided Minnetronix engineers deeper insights on innovation, but the devices themselves will help the CMO forge tighter connections with OEMs that want to sell the device.

Medtech suppliers also boosted their support of startups in the industry as they formally set up incubators and accelerators.

As we (hopefully) leave the COVID-19 pandemic behind us, I think there are exciting times ahead for the medical device industry and the companies serving it.

There’s also a change afoot here at Medical Design & Outsourcing.

Nancy Crotti has decided it’s time to retire. Nancy took over MDO as managing editor in late 2019 and brought it to new heights amid the pandemic. We’ll miss her clear writing, insights and overall good humor.

Meanwhile, the search is well underway for a new MDO managing editor, so stay tuned.

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Medical Design & Outsourcing

7 • 2021

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CONTRIBUTORS

DAVID

KEARNS

KLODOWSKI

LEBOVITZ

MCANULTY

BENNY DAVID is business development director for biomaterials and drug delivery for NuSil. He has spent his career focused on the polymer industry — with R&D, business development and commercial roles in the healthcare, aerospace, defense, electronics, industrial and automotive industries.

RICHARD LEBOVITZ is the founder and CEO of LeanDNA, an analytics platform for factory inventory management. Built by lean experts, LeanDNA’s goal is to empower supply chain professionals to dramatically reduce excess inventory, deliver on time and establish operational command.

TIM KEARNS is sales manager for pharma and medical devices for Videojet Technologies.

TIMOTHY MCANULTY is a partner at Finnegan, Henderson, Farabow, Garrett, & Dunner. He practices all aspects of patent law, including district court litigations, postgrant proceedings, due diligence, strategic counseling, and portfolio development.

DANIEL KLODOWSKI is an attorney at Finnegan. His practice focuses on post-grant proceedings before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), litigating patents in district court and at the International Trade Commission (ITC), and prosecuting patent applications in several mechanical and electrical technologies.

www.designworldonline.com/category/future-design-engineering/

www.medicaldesign&outsourcing.com

7 • 2020

Medical Design & Outsourcing

7

CONTENTS

medicaldesignandoutsourcing.com ∞ July 2021 ∞ Vol7 No4

COLUMNS 6

HERE’S WHAT WE SEE:

7

CONTRIBUTORS

• • • • • THE CMOS ISSUE

44

ON THE COVER

3 ways medtech suppliers are adapting to a new world

12 DRUG DELIVERY:

How Fractyl Health is ‘reversing’ type 2 diabetes

CONTRACT MANUFACTURERS FUEL MEDTECH EXPANSION IN COSTA RICA Medical device manufacturing is flourishing in the Central American country, spurred by a host of incentives.

16 IP ISSUES:

What you should know about the Patent Trial and Appeal Board

22 MANUFACTURING:

How analytics could transform medtech manufacturing

24 MOLDING:

In situ cure technology molds next-generation medical implants

FEATURES

28 ORTHOPEDICS:

Smith+Nephew makes a play in remote physical therapy

32 PACKAGING:

How to choose the right printing technology for UDI codes

34 PHARMA:

Meet the drugs and devices giving hope to millions of migraine patients

39 TUBING TALKS:

How Abbott engineered a catheter-delivered device for premature babies

62 DEVICETALKS:

Martha sets 800 million patient mark for Medtronic

64 AD INDEX 8

Medical Design & Outsourcing

7 • 2021

50 HOW CONTRACT MANUFACTURER MINNETRONIX DECIDED TO MAKE ITS OWN MEDICAL DEVICE Medtech contract manufacturers such as Minnetronix often avoid making their own devices. But CEO Jeremy Maniak had a different idea.

54 THIS IMAGING DEVICE COULD BE A BREAKTHROUGH FOR BREAST CANCER TREATMENT

OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery.

58 PHYSIQ IS ADVANCING DIGITAL THERAPEUTICS THROUGH ITS PARTNERSHIP WITH JANSSEN A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform.

www.medicaldesignandoutsourcing.com

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How Fractyl Health is 'reversing' type 2 diabetes to reduce or eliminate insulin injections Fractyl Health CEO Harith Rajagopalan envisions a scenario in which those with type 2 diabetes don’t have to rely on insulin injections.

I Sean Whooley | Associate Editor |

nsulin has long been a staple of treatment for type 2 diabetes patients who need to manage their blood sugar levels, but Rajagopalan’s aim is to go beyond that temporary fix.

Trained as a cardiologist, Rajagopalan cared for patients with cardiovascular disease and coexisting type 2 diabetes.

While serving as a cardiology fellow at Brigham & Women’s Hospital in Boston, his dad and uncle were diagnosed with type 2 diabetes. That put the wheels in motion for Lexington, Mass.–based Fractyl Health and its Revita DMR procedure.

“I started to think really hard about that disease and really began to realize that a lot of the therapies that we’re applying in type 2 diabetes are symptomatically focused on the blood sugar but not focused on treating the underlying disease at all,” Rajagopalan told Drug Delivery Business News.

Thinking about the role of the duodenum in the insulin resistance that causes type 2 diabetes led Rajagopalan to start Fractyl about 10 years ago. The company has developed a therapy to change the trajectory of the disease rather than putting a Band-Aid on its symptoms, as the CEO puts it. That therapy, Revita DMR, is designed with the ultimate goal of creating a way to allow the pancreas to regulate blood sugar better on its own.

An outpatient endoscopic procedure, Revita DMR works to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes. A gastroenterologist performs the procedure with the aid of an endoscope. Fractyl’s catheter runs through the mouth and past the stomach, into the duodenum

alongside the endoscopic camera. A gastroenterologist uses a bedside system with an interface that Rajagopalan likens to an iPad to activate the catheter to deliver a precise amount of heat energy to the lining of the duodenum, causing the targeted destruction of overgrown cells that line it.

The procedure takes approximately one hour, requires a stay in a recovery room for 90 minutes or so and then allows the patient to return to normal life the next day.

Prototype illustration of future Revita DMR console Image courtesy of Fractyl Health

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Medical Design & Outsourcing

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“This is less involved than going in for a colonoscopy, and the safety profile has been very reassuring so far,” Rajagopalan said.

“Throwing more insulin at the problem puts people at risk of weight gain and blood sugar dropping too low, and there’s a lot of effort involved in managing the injection of insulin,” he added. “Often, that’s really burdensome for people. Revita is designed to be for patients who are not achieving good glucose control on insulin and for whom the burden and risks of more insulin are unattractive or undoable.”

A lot of the therapies that we're applying in type 2 diabetes are symptomatically focused on the blood sugar but not focused on treating the underlying disease at all.

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The platform has CE mark approval in Europe and in April garnered FDA breakthrough device designation in the U.S., with Fractyl now enrolling patients in the Revita-T2Di study that will evaluate the procedure.

The company also confirmed that CMS approved coverage of routine costs for Medicare patients in the Revita-T2Di trial, with all eligible participants set to receive study-related health assessments at no cost. The decision allows for reimbursement coverage to clinical research centers for certain trial-related expenses.

The catheterdelivered Revita DMR works to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes.

Device is not FDA approved and is for investigational use only.

Image courtesy of Fractyl Health

The Emerson logo is a trademark and a service mark of Emerson Electric Co. © 2021 Emerson Electric Co.

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Medical Design & Outsourcing

7 • 2021

Fractyl Health CEO Harith Rajagopalan “Having breakthrough device designation is a really great sign of how we’ve been able to work with the FDA to try to find a patient population where we could offer a real potential benefit and a reasonable expectation that the trial we’re conducting could be better than the standard of care for these patients,” Rajagopalan said.

“That’s really what breakthrough therapy designation is about and we’re really pleased that we were able to obtain that designation.”

Rajagopalan said Fractyl’s focus now is on the Revita-T2Di study, for which the company is currently training physicians while working to get the trial up and running across 30 sites in the U.S., as well as at a handful of locations in Europe, too.

Fractyl aims to complete enrollment and have primary endpoint data in 2023, with interim data expected in about a year from the first phase of the study. With European approval secured, Fractyl plans to seek out insurance reimbursement in different European geographies before commercializing, while approval and launch in the U.S. are expected after the 2023 data readout.

“What we really want to offer is a therapy that can reverse insulin resistance so that we can improve blood sugar control as we reduce or eliminate the need for insulin,” Rajagopalan said.

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7 • 2021

Medical Design & Outsourcing 15

3 things medical device companies should know about the Patent Trial and Appeal Board With nearly a decade of proceedings behind it, the Patent Trial and Appeal Board (PTAB) has established a record. Medtech companies can learn from it.

O

T i m o t h y P. M c A n u l t y | Finnegan |

D a n i e l F. K l o d o w s k i | Finnegan | 16

Medical Design & Outsourcing

ne of the key aspects of a strong patent is the owner’s ability to enforce it. And when a patent is asserted against an accused infringer in court, two core issues always arise: whether the patent is infringed, and whether it is valid. Because there can be no infringement if the patent is not valid, attacking a patent as invalid (or “unpatentable”) is one of the primary defenses for every alleged infringer.

Patent validity can be challenged in several forums, including in court as part of an infringement litigation. It’s also possible to challenge validity through various “postgrant” procedures at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB). The PTAB was created in 2012 and has become a popular forum, receiving over 10,500 patent challenges to date. The PTAB provides a relatively fast, focused, and cost-effective mechanism for resolving validity issues, and patent challengers face a lower evidentiary burden at the PTAB than in court.

While every patent and PTAB proceeding is unique, medical device companies can learn several lessons from the past several years of PTAB 7 • 2021

decisions. The lessons can apply equally to companies building a patent portfolio (such as for investment, acquisition, or enforcement) and companies challenging patents as unpatentable.

Here are three key points: 1. Not all patents are created equal The PTAB’s case outcomes highlight the differences between high-quality and low-quality patents. Strong, high-quality patents often share several important qualities, including a clear description of the invention’s subject matter and the accompanying claims, which are the legally operative part of the patent defining the legal boundaries of protection. Strong patents also include strategically focused claims detailing competitive aspects of the invention, targeting specific types of infringers such as direct competitors, endusers, or device manufacturers.

Strong patents also often include a versatile mix of broad and narrow claims directed to different aspects of the invention. While narrower claims are limited in scope, and thus may cover fewer infringing products or services, they may be more defensible from a validity

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IP ISSUES

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attack. Conversely, broader claims may cover more infringing activities (with a resulting increase in a potential financial award) but may be more vulnerable to an invalidity challenge.

A full proceeding at the PTAB includes two phases. In the first phase, the PTAB determines whether to institute a formal review of the challenged patent based on preliminary briefing from the parties that typically focuses on whether the challenger’s initial petition satisfies the substantive and procedural requirements for review. The second phase is the trial itself, where the parties prepare further substantive briefing regarding the validity of the patent’s claims. The patent challenger bears the burden of proving the patent’s claims are invalid, and the

PTAB issues substantive decisions at the end of both phases.

Importantly, the PTAB’s final written decisions (issued at the end of a trial) demonstrate the value of having a mix of claims with varying scopes within either a single patent or across multiple patents.

On average, the PTAB instituted a review of roughly 60% of the challenges filed from September 2013 through April 2021.

For those instituted cases, about 63% of the cases resulted in no challenged claims surviving — in other words, all challenged claims were found unpatentable. For the same set of instituted cases, only about 18% resulted in every challenged claim surviving. Thus, if a PTAB case is instituted, it is likely that at least some claims will not survive.

A key outcome to consider for patent strategy is a “mixed outcome,” where at least one instituted claim survives and at least one is ruled unpatentable. A mixed outcome occurred in approximately 18% of the PTAB’s decisions to date.

Because only one patent claim needs to be deemed “not unpatentable” (i.e., valid) and infringed for a competitor to be liable for infringement, a mixed outcome can still lead to a significant win for a patent holder even if other claims in the same patent are ruled unpatentable. As a further benefit, an accused infringer can be legally prohibited from repeating the challenges raised — or that could have been raised — against the surviving claims, thus immunizing the surviving claims and streamlining the remaining issues in a patent infringement lawsuit.

Notably, the PTAB provides a limited procedure for amending patent claims that have been challenged; but to date, the vast majority of attempts to amend claims have not succeeded. Therefore, patent owners are better served by investing upfront in obtaining a diverse, strategically crafted set of patent claims during the patent application process, rather than relying on amending issued patent claims before the PTAB. 2. Some technology areas fare better than others As a whole, the PTAB has proven to be a difficult forum for patent owners.

Through the end of April 2021, about 75% of the claims that the PTAB instituted review of were ultimately ruled unpatentable.

But the survival rate of instituted claims varies widely depending on the type of technology at issue. For example, patents in the field of biotechnology and organic chemistry (which the USPTO refers to as “technology center” (TC) 1600) had an instituted claim survival rate above 41%. However, the survival rate for instituted claims in the field of mechanical engineering (TC 3700) — which includes traditional medical device inventions — had a survival rate just above 28%.

Certain technology areas have fared even worse, such as technologies relating to computing and electrical engineering, which include digital health inventions.

For example, computer architecture and information security (TC 2100) and communications (TC 2600) have both had claim survival rates below 20%.

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www.medicaldesignandoutsourcing.com

Understanding this variance in outcomes for different technologies is important for medical device companies, which develop innovations across numerous technical fields. Patent owners benefit from seeking protection for ideas across a wide range of technologies as part of crafting a versatile patent portfolio and should avoid focusing each aspect of a patent portfolio within just a few technical fields—especially those that may be more susceptible to challenges at the PTAB.

As a whole, the PTAB [U.S. Patent and Trademark Office's Patent Trial and Appeal Board] has proven to be a difficult forum for patent owners. ®

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7 • 2021

Medical Design & Outsourcing 19

IP ISSUES

In contrast, in 2019 — the year most favorable for patent owners — the PTAB invalidated all instituted claims in just over 54% of the cases. While the number of cases where no instituted or substitute claims survived was still relatively high, at least one instituted claim survived in over 45% of the cases.

3. Patents require a long-term perspective For a variety of reasons, invalidity proceedings at the PTAB have evolved significantly since 2013. In 2015 — the year most favorable for patent challengers –– the PTAB invalidated every instituted claim in over 76% of its cases. Cases where all instituted claims survived, as well as cases with a mixed outcome where at least one instituted claim survived, were both below 12%.

PTAB outcomes have greatly varied over time, reflecting numerous changes in PTAB practice and procedure generally resulting in increased patent claim survival rates. But regardless of the short-term trends in case outcomes at the PTAB, patent owners are well served to continue maximizing the strength of their patent portfolios moving forward. For example, patent owners can maintain pending patent applications within a given patent family for several years, even when earlier-issued patents within the same family are asserted against competitors and challenged in court or at the PTAB. A patent owner may pursue alternative claims to strengthen the patent against an invalidity attack or better tailor it to a competitor’s evolving products or services by maintaining such pending applications.

Both petitioners and patent owners before the PTAB have grown more sophisticated over time. The lessons learned from the PTAB apply to each aspect of a patent’s lifecycle, including the initial application process. Patent owners can benefit from adopting a mindset of long-term portfolio development, with strategies that align business goals with offensive and defensive strategies.

Conclusion The PTAB is an important forum for patent owners and challengers alike. The outcomes of cases over the past eight years underscore several key takeaways for patent owners, including the high value of strong patent portfolios that span different technologies and that include a variety of claims targeting different infringing activities.

Patent owners also benefit from adopting a long-term approach to developing a diverse, adaptable patent portfolio to achieve strategic business objectives.

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MANUFACTURING

How analytics could transform medtech manufacturing Industries like aerospace had decades to embrace advanced technology, analytics and workflows, but medtech manufacturers must make the same shift in a fraction of the time.

Richard Lebovitz | LeanDNA |

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edical device manufacturing is on the verge of major transformation. Over the last 30 years, industries such as automotive, aerospace and consumer goods have modernized their product innovation strategies with advanced analytics models to scale manufacturing and keep up with evolving demands.

Now it’s time for the medical device industry — a sector with a growing need for high-volume cost-efficient production — to do the same.

Why now?

Merger and acquisition activity in the sector over the last 10 years has broadened sales and distribution networks for medical device manufacturers. This market consolidation has brought a major improvement opportunity for these organizations to build new efficiencies across all manufacturing sites, systems and

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supply networks. Creating this new level of efficiency will ultimately drive increased production output, improved product quality, lower costs and strengthened supplier relationships for product innovation — all critical aspects to solving many of today’s top healthcare issues.

The medical device industry was ready for a new, analytical manufacturing model in 2019, but the coronavirus pandemic has catalyzed the transformation from a niceto-have to a core business mandate. While industries like aerospace had decades to embrace advanced technology, analytics and workflows, given today’s market dynamics, medical device manufacturers will have to make the same shift in their factories in a fraction of the time. Before COVID-19, some projected maintaining the status quo and not embracing digital transformation could mean losing 21% of profits, according to a report by KPMG. That figure is now arguably growing.

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Image courtesy of Unsplash

The best place to start is with inventory. When teams have a realtime, accurate and harmonized view of inventory levels, they’re better positioned to quickly balance inventory across even the most complex and multi-sourced supply chains and ramp production up and down to respond to demand changes. They can also make faster decisions in the factory that further organizational goals, speed time-to-market, create competitive advantages and give healthcare providers what they need to improve patient outcomes.

Using analytics for a competitive edge The daily factory management problems facing medtech manufacturers — managing shortages, optimizing inventory, dealing with supplier delivery issues and more — are not new. These are all common battles, especially when teams

rely on antiquated systems. Spreadsheets and home-grown business intelligence solutions that have served manufacturers and factories well in the past are no longer sufficient, given the growing complexity of contract manufacturing, which is amplified by globalized supply networks and the disparate systems and processes that come with the industry’s uptick in M&A activity.

Teams often turn to spreadsheets because they don’t have readily available and centralized data. Leading medical device companies are now tapping into a combination of analytics, automated workflows and dashboards, advanced collaborative tools and artificial intelligence to boost visibility and actionability across the factory. The new analytically driven approach makes it possible to manage these daily factory management challenges and drive improvements in weeks, rather than the months it took manufacturers in the past, because teams can:

challenges to embracing new technology are adoption and change management, medical device manufacturers can luckily bypass lengthy deployments by looking at similar manufacturing innovations in other industries.

Their neighbors in aerospace and automotive have built and used this analytical model for years. This includes fostering a company culture that embraces change, proactively involving employees in the implementation process and getting their buy-in by showing how the technology will help them perform better in their specific roles and introduce the technology with clear user guidelines and repeatable processes.

Every manufacturing team needs a clear view of supply chain operations so they can prioritize, troubleshoot, collaborate and innovate in real-time.

• Quickly prioritize and respond to changes that can’t be predicted with traditional tools and prescribe urgent actions to factory employees.

• Get a global view of supply and demand data and optimize inventory across single sites and multi-site networks.

• Fix inventory and delivery issues when plans change.

• Share inventory information and collaborate faster with colleagues on inventory issues and opportunities without sending emails and files back and forth.

• Standardize inventory processes with built-in workflows so teams know what to do and use best practices every time.

Every manufacturing team needs a clear view of supply chain operations so they can prioritize, troubleshoot, collaborate and innovate in real-time.

Analytics helps teams deliver on all four needs. While two of the biggest www.medicaldesignandoutsourcing.com

Necessity: The mother of invention and driver of change We’re seeing similar catalysts for change in the medical device sector as we did in the automotive industry post-World War II and in the aerospace industry with the shift from military to commercial aircraft. The COVID-19 pandemic has highlighted the need for agility and speed-to-market and intensified cost-cutting pressures in medtech manufacturing. Outside of the health crisis, an aging population, more health-conscious consumers and increasing healthcare expenditures are driving strong market growth. In fact, before COVID hit, the medical device industry was expected to reach nearly $800 billion by 2030, KPMG reported.

Competitiveness relies on continuous innovation and efficiency. Manufacturers that infuse analytics into their factory operations are in a much better position to outperform.

Embarking on the transformation improves decision making and net working capital, and strengthens customer relationships and outcomes through better products, lower price points and faster deliveries.

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MOLDING

In situ cure technology molds next-gen medical implants Silicone technology innovation has moved beyond defining specific material characteristics and into offering implantable devices that cure and form into shape inside the human body.

Designed specifically to allow sterilization of uncured medical-grade silicones, this new packaging solution for in situ curable silicones features a dualcartridge prefilled dispensing system.

Image courtesy of NuSil by Avantor

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edical device manufacturers have long relied on highly purified silicone elastomers to fabricate components or entire devices for implantation. Now, innovations offer manufacturers new opportunities to create in situ-cured implants that are highly customized and require less invasive implantation procedures.

Silicone has a long-established history of biocompatibility, making it a highly valued material among device makers. Its unique chemical make-up allows silicone manufacturers to precisely fine-tune the material at the polymer level to meet specific medical device requirements — such as cured physical properties ranging from extremely pliable to very rigid and uncured characteristics from pourable to thixotropic.

With qualities like biocompatibility and versatility, silicone has historically had a range of applications, from cardiovascular pacemakers and Cochlear implants to implantable infusion pumps, intraocular lenses and drug delivery implants. It’s attractive for a variety of medical uses, like high-precision molded parts, lubricious coatings for medical

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devices, soft silicones for wound care and soft tissue implants.

Silicone elastomers are typically used to fabricate components of devices, or entire devices, which are then assembled, packaged and sterilized prior to surgical implantation. Now, innovation in silicone technology has moved beyond defining specific material characteristics and into offering implantable devices that cure and form into shape inside the human body. In essence, this creates personalized, “real-time” implants that conform to the shape at the implant site, rather than requiring the body to conform to a standard implant shape.

The traditional method for producing silicone implant devices can vary between manufacturers.

Since common silicone sterilization methods, like gamma and electronbeam irradiation or autoclave, can affect the characteristics or workability of the silicone, ethylene oxide (EtO) is often used for medical device sterilization.

The cured component is then combined with other device components and placed in a single package or tray, which is then sealed and sterilized prior to surgical implantation.

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When designing portable or stationary instruments, OEMs are often challenged with meeting aggressive size, power, and weight limitations, all without sacrificing the remaining elements of system-level performance.

Each subcomponent is therefore pushed to offer improved performance within a smaller footprint.

Featuring high flow and low power consumption, genvi solenoid valves are the solution. An extremely tight leakage rating reduces compressor demand and further underscores the valve’s ability to provide consistent long-term operation across an extensive cycle life.

Custom valve solutions, supported by The Lee Company’s engineering experience in microfluidics, are also available to meet specific application requirements.

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MOLDING

How in situ cure technology works New silicone dispensing systems developed specifically for the healthcare industry allow in situ sterilization of uncured medical-grade silicones.

Featuring a pre-filled, dual-cartridge dispensing system, each barrel employs a gas-permeable plunger seal that allows an EtO sterilant gas to permeate the plunger seal and sterilize the uncured silicone inside the cartridge. The silicone can then be delivered directly into the human body wherever the device is needed, whether it’s intended to provide cushioning or fill a void.

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The advantages of in situ cure technology In situ curing gives device makers a novel therapeutic solution: a customized, “realtime” implant. From elasticity to fatigue resistance to hardness, manufacturers can target specs for specific properties that increase a device’s functionality.

This versatility creates a range of opportunities for new therapies in cardiovascular, neurological, urological and ophthalmic aesthetic implants and drug delivery applications. Research and some development are already underway in many of these applications. It’s possible in bone and vertebral repair, for example, that in situ-cured silicones could enable a custom-fit device that is more flexible than current offerings, thus allowing for a greater range of motion for the patient.

The ability to specify the material’s final physical properties is particularly important when designing devices for implantation. For example, specifying a hardness level can offer firmer support or softer cushioning.

Likewise, viscosity can be optimized for the desired implant’s location within the human body. Cure time can be adjusted to the device manufacturer’s specification so that the silicones cure at body temperatures in the time frame desired. The material can also be made radiopaque, and either insulative or conductive properties can be tailored within the silicone formulation.

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The dispensing system innovation enables new therapies to be developed — ones that could not be achieved before because of the surrounding anatomy. By providing an alternate method of surgical implantation, in situ-cured silicone can be provided as a part of the surgical kit and formed within the body to create a customfit device. As a result, therapies can be customized to the patient’s anatomy.

Understanding in situ curing technology and its advantages allows medical device makers to explore opportunities to fabricate implanted silicone-based devices that are customized for fit and performance and require lessinvasive surgical procedures, resulting in shorter recovery time for the patient.

New dispensing technology can provide an alternate method of surgical implantation, where uncured, pre-sterilized silicone can be part of the surgical kit and formed within the body during the surgical procedure, resulting in a custom-fit device.

Image courtesy of NuSil by Avantor

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ORTHOPEDICS

Smith+Nephew makes a play in remote physical therapy The British medtech giant seeks to tap digital health to fuel growth in orthopedics. The Aria Home PT remote physical therapy device is the latest example.

I Chris Newmarker | Executive Editor |

t’s the size of a small flatscreen TV and shows up at someone’s house before they undergo knee or hip surgery at an ambulatory surgery center, interacting with them throughout the entire episode of care. Think interactive home physical therapy sessions, education, telehealth visits and more — all delivered with the help of a friendly avatar called Aria.

That’s the promise that Smith+Nephew officials see in their Aria Home PT remote physical therapy device, launched in May as one of the latest additions to the company’s Aria digital care management platform.

“Our goal is to be the fastestgrowing, most innovative orthopedic company out there, and our focus on digital health is one of the ways that we’re getting there,” said Laura Rector, S+N’s VP of ambulatory surgery center strategy and digital health.

Aria Home PT

Image courtesy of Smith+Nephew

As knee and hip replacements move from hospitals to outpatient ambulatory surgery centers and payers such as Medicare engage in bundling to incentivize outcomes, orthopedic device companies look to digital health tools to boost results. Zimmer Biomet, for example, has its ZBEdge portfolio of remote care and patient engagement management systems that includes MyMobility with Apple Watch.

CAN SMITH+NEPHEW’S ARIA OPEN UP ASC ORTHO MARKET? In this episode, Chris Newmarker, executive editor of life sciences, speaks with Laura Rector, Smith + Nephew’s vice president of ambulatory surgery centers and digital health, about the company’s Aria care management platform. www.devicetalks.com/podcasts/

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www.medicaldesignandoutsourcing.com

Our goal is to be the fastest-growing, most innovative orthopedic company out there, and our focus on digital health is one of the ways that we're getting there.

Rector touts Smith+Nephew’s Aria Home PT and overall Aria platform as ahead of the competition — designed with the ambulatory surgery centers specifically in mind.

“It’s the only product that provides the total automation of streamlined activities that impact that whole episode of care,” Rector said during a recent interview with Medical Design & Outsourcing and MassDevice’s DeviceTalks Weekly podcast. (Listen to the discussion in our June 4 edition of the podcast.)

The line that Rector repeated was that the company wants to help people “live a life unlimited.”

The feature that sets the Aria Home PT apart from typical consumer electronics with screens, cameras and communication is the device’s 3D camera — able to track number, duration and quality of reps on 25 different joints in the body, according to Rector.

“It captures that full 3D image. It can capture the biomechanics, it has AI learning in it, and it gives feedback in real-time of whether they’re doing the exercises right,” Rector said.

The Aria Home PT doesn’t replace physical therapy; it enhances it, according to Rector.

“The PT can go in and actually look at the video of the patient doing their physical therapy,” Rector said. “They can look at all the outcomes and results of how much frequency and time they use the device, how many repetitions they did, how well they did on those repetitions.”

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Medical Design & Outsourcing

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The result, according to S+N, is that people with knee or hip replacements adhere better to their physical therapy routines, which results in improved outcomes and reduced costs for healthcare systems. The company points to a randomized control trial at Duke University that found the Aria Home PT to be as safe and effective as traditional physical therapy, with decreased readmissions, outpatient visits, home health visits and urgent care or ER visits.

Average savings were $2,745 per patient.

[The Aria Home PT is] the only product that provides the total automation of streamlined activities that impact that whole episode of care.

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“The biggest bane in healthcare is, ‘How do you get a patient to be more compliant?” Rector said.

In the Aria Home PT’s case, Smith+Nephew found the device had a Net Promoter Score of 90.3, which means that more than 90% of users have a favorable view about it. Rector said: “You need it to be technology-friendly enough that they will use it.”

Kaila Krum, managing director at Truist Securities, has seen orthopedic companies such as S+N showing more interest in end-to-end care to help improve patient outcomes and reduce healthcare system costs.

“While it is a little too early to say yet whether products like this can attract patients and shift market share, we will be following it closely to see how the field adopts products like this.”

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PACKAGING

How to choose the right printing technology for UDI codes UDI labeling can identify medical devices through their distribution and use.

The deadline for labeling Class 1 and unclassified devices is coming up.

W

hether you are expanding the production of medical devices already subject to Unique Device Identification (UDI) requirements or finishing your plan to meet the FDA’s UDI requirements for Class I devices, you’ll want to attain high-resolution printing of variable codes on devices and their packaging.

UDI paves the way for traceability To improve medical device traceability, the FDA established the UDI system and implemented it in phases, beginning in 2014. While the agency delayed UDI compliance for Class I and unclassified devices until September 2022, full compliance for medical devices in Class II and III and implantable life-supporting and lifesustaining devices is currently required.

The UDI system requires labeling medical devices with a unique device identifier in both a human-readable (plain-text) form and a machinereadable form that uses automatic identification and data capture (AIDC) technology. These identifiers must appear on labels and packaging, and sometimes on the devices themselves.

Tim Kearns | V i d e o j e t Te c h n o l o g i e s |

UDI information is usually a combination of alphanumeric text and GS1 Data Matrix or GS1 128 codes. The codes carry a unique device identification number and production data such as a batch code, lot number, expiration date or date of manufacture. The FDA defines the codes with two parts: 1. Device identifier (DI), a mandatory, fixed portion that identifies the labeler and the specific device version or model.

2. Production identifier (PI), a conditional, variable portion that identifies one or more of the following for each specific device: • • • • •

Lot or batch number; Serial number in YYYY-MMDD format; Expiration date in YYYY-MMDD format; Date manufactured in YYYYMM-DD format; Distinct identification code required by §1271.290(c) for a human cell, tissue or cellular and tissue-based product (HCT/P) regulated as a device.

Laser marking systems are commonly used to print and mark directly on medical devices due to their ability to produce permanent codes on many hard plastics, glass and metal. The optimal printing and marking technology for a given application depends on factors including the packaging substrate, equipment integration, production speeds and code requirements.

A Videojet Wolke m610 oem thermal inkjet printer Image courtesy of Videojet

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Human and machinereadable codes produced by (clockwise from upper left) a thermal inkjet printer, a thermal transfer overprinter (TTO) and a UV laser Image courtesy of Videojet

How UDI can work with Tyvek Let’s take a closer look at a prevalent packaging choice for medical devices: DuPont Tyvek and similar medical papers.

Tyvek is made of very fine and continuous filaments of virgin high-density polyethylene (HDPE. It’s a popular medical device packaging material because of its tear resistance, durability, breathability, microbial barrier properties and compatibility with sterilization methods.

Various Tyvek styles meet medical packaging performance requirements for mechanical strength and protection, with the material forming pouches, bags and form-fill-seal lids.

Because of Tyvek’s texture and unique properties, choosing a technology to print UDI codes on it requires careful consideration.

Depending on the line setup, speed requirements and the type of Tyvek selected, three distinct printing and marking technologies can provide durable human- and machinereadable UDI-compliant codes.

Thermal inkjet is a non-contact printing technology that enables high-speed, highresolution printing on Tyvek 1073B, 1059B, 2Fs and 40L with certain solvent-based and water-based inks. The printer cartridge’s multiple nozzles propel ink drops to produce the high-resolution codes.

Multiple thermal inkjet printheads can be mounted on the web of thermoformers and positioned to print codes on a lidding web before heat sealing. The printheads traverse the web, coding multiple packages in a single pass while matching the index rate. These systems support

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job information from an external database and from a hand-held bar code scanner.

With TTO technology, a digitally controlled printhead precisely melts ink from a ribbon directly onto Tyvek to print high-resolution codes and alphanumeric text. A manufacturer can integrate TTO printers on intermittent- or continuous-motion flexible packaging lines and ultrafast horizontal form-fill-seal equipment.

Certain ribbons made with a blend of wax and resin provide excellent adhesion, contrast, and light resistance on Tyvek 1059B, 2Fs and 40L. UV lasers work by focusing and steering a beam of UV light with a series of small mirrors to generate permanent, high-contrast marks, providing excellent marks on Tyvek 2Fs. The laser’s UV wavelength creates a color change through a photochemical reaction on the material without damaging it. This laser technology doesn’t require supplies like inks or ribbons.

Your operation’s throughput, utilization, investment and operating costs are all considerations when selecting a printing or marking technology to help meet UDI code requirements.

Temperature and humidity can also affect a printer or laser’s performance, so you should test your packaging and products in relation to your environment to help determine the best solution.

Whether selecting thermal inkjet, thermal transfer, or UV laser technology, an experienced coding solution provider can guide you to the optimal technology for UDI coding on Tyvek packaging. They can also identify and implement complex data management software to help you meet the code and traceability demands of UDI.

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Medical Design & Outsourcing 33

PHARMACEUTICALS

Meet the drugs and devices giving hope to millions of migraine patients

Theranica’s Nerivio has an arm-band form factor.

Image courtesy of Theranica

Up until recently, neurologists had relatively few tools at their disposal to help migraine patients.

T Brian Buntz | Pharma Editor |

he treatment landscape for migraines has evolved considerably in recent years, according to Dr. Alexander Feoktistov, founder and president at the Synergy Integrative Headache Center in Chicago.

“I’ve been in this field of headache medicine for probably over 20 years now, and I’ve never been as excited to work in this field as in the past few years,” he said.

Feoktistov recently spoke with MDO sister publication Drug Discovery & Development to discuss both drug and device treatments for migraine headaches, which affect roughly 1 billion people globally.

DD&D: How has the migraine treatment landscape evolved in recent years?

Feoktistov: It has been unprecedented.

It’s like a small revolution in the headache medicine field in the past three years.

So the first CGRP [calcitonin generelated peptide] monoclonal antibody, which was erenumab-aooe, came out

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in May of 2018. And since that time, we’ve had three other CGRP monoclonal antibodies come out. We’ve had two gepants [CGRP receptor antagonists] come out as acute treatments. We’ve had a 5-HT1F receptor agonist come out known as Lasmiditan. And now, one of those gepants [recently] was approved for prophylactic use.

It’s unbelievable, but we have never experienced this type of development of new medications specifically developed for migraine treatment.

If you think about it, migraine is a pretty ancient condition. Hippocrates described migraines in his papers with great detail.

We’re talking about thousands of years of migraine history, yet 2018 was the first year we had a drug specifically developed for migraines. Before the first CGRP monoclonal antibody, everything else we used for migraine treatment was developed to treat something else, whether it was a seizure disorder, high blood pressure or depression. We sort of

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PHARMACEUTICALS

borrowed those medications from other fields. But CGRP is the first dedicated class of drugs for migraine alone.

The landscape is changing.

DD&D: What about the device landscape for migraines?

Feoktistov: We also have this relatively novel field of headache medicine called noninvasive neuromodulation that’s also evolved pretty intensely over the past several years.

We now have four FDA-cleared devices for migraine treatment either acutely or prophylactically. Those are the noninvasive nerve stimulators that utilize different mechanisms of action. They all work very differently in showing promising results as far as offering our patients nonpharmacological/non-medicinal options to treat headaches.

The most commonly used treatment now is called Cefaly, which is a brand name.

It’s a supraorbital/supratrochlear nerve stimulator. It is a relatively small device that a patient puts on their forehead between

the eyebrows. Patients put a sticky electrode on the skin and then attach the device to it. After the press of a button, it electrically stimulates those supraorbital and supratrochlear nerves that innervate the forehead. Those are the major sensory nerves from the trigeminal nerve, the main sensory nerve in the head and face area. That’s the nerve that gets actively involved and activated during the migraine attack. So patients apply the stimulation. And depending on the type of stimulation and the duration, it could be used prophylactically or acutely. So, acutely a patient would apply one-hour-long stimulation with migraine onset.

Prophylactically, a patient would apply 20 minutes of stimulation every single day, regardless of whether they have a headache or not.

This stimulation can

ElectroCore’s GammaCore Sapphire device Image courtesy of ElectroCore

cause the sensation of pins and needles in the forehead. It is something patients will have to get used to. But it was FDA cleared many years ago, and, in November of 2020, it became over the counter. It no longer requires a prescription.

The second device that we’ve been using extensively with a lot of research behind it is a so-called noninvasive vagus nerve stimulation device. The brand name is GammaCore Sapphire. This device is a handheld device that patients hold in their hand. They apply stimulation to the side of their neck right below the jaw. They apply proprietary stimulation to the vagus nerve fibers located next to the carotid artery.

Once that patient finds the vagus nerve, they apply this device to that area. They continue stimulation for just literally a couple of minutes with migraine or cluster headache onset.

Patients can then use the stimulation regularly as well for prophylactic use for either migraine or cluster headaches. It has been FDA cleared to be used for migraine and cluster headache treatment — acutely and prophylactically.

In February of this year, it received an extended indication to treat adolescent migraine as well. And its mechanism of action is sophisticated. Multiple human clinical trials were done that were placebocontrolled and randomized. They found GammaCore to be very effective and very well tolerated by patients. Its mechanism of action is unique. It changes certain neurotransmitter levels. It impacts socalled cortical spreading depression, which is a neurophysiological phenomenon

The Cefaly Dual migraine treatment device is now available without a prescription.

Image courtesy of Cefaly

and then patients turn on the device using the smartphone app to start the stimulation.

As they continue the stimulation for about 45 minutes, patients can regulate the intensity, which should be pretty intense.

It should not be painful, but it should be very noticeable. Patients use it for about 45 minutes. This device is approved only as an acute treatment. Patients use it at the onset of a migraine attack. It’s supposed to abort the migraine attack. Studies have looked into the overall patient satisfaction when

It's unbelievable, but we have never experienced this type of development of new medications specifically developed for migraine treatment. involved in migraine aura development.

It’s not a painful stimulation. Patients feel a little bit of tingling.

Finally, the other device that we’ve had a lot of success with is called Nerivio. This device is made in Israel. It is an example of remote or conditioned pain modulation. It’s almost like an armband applied above the elbow and below the shoulder. This device is connected wirelessly to a smartphone,

patients use Nerivio stimulation instead of standard-of-care oral medication treatment of migraine.

Patients frequently were more satisfied with the electronic stimulation than the oral tablets.

DD&D: There are some reports of neurologists having a high prevalence of migraines. A 2018 study in Brain Behavior www.medicaldesignandoutsourcing.com

reported that between 27.6% and 48.6% of neurologists have migraine headaches. What’s your take on that?

Feoktistov: If a neurologist is familiar with migraines, it’s very hard to misdiagnose.

They would literally feel it and know what is going on. Sometimes patients can’t verbalize or describe some of their symptoms. Certainly, if a neurologist experiences a migraine attack and knows what a migraine attack feels like and looks like, it’s probably much easier to diagnose.

DD&D: How often do you see patients whose migraines are non-responsive to treatment?

Feoktistov: It’s a prevalent theme, unfortunately. Migraine can present differently in some patients. They have different clinical symptoms sometimes. In some patients, nausea is very prevalent.

And in other patients, nausea is minimal, if it is present at all. In some patients migraine, develops very rapidly. It takes several hours for the migraine to start from a level zero and go to a more severe stage in other patients. It could take half of the day for some patients.

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PHARMACEUTICALS

efficacy. Maybe 50% of the time, you have to go back and revisit with the patient and adjust the medication or switch them to something else. I wouldn’t say that we’re expecting that, but it’s something that we encounter very frequently.

Plus, migraine is a very multifactorial condition. There are many different factors and even pathophysiological mechanisms that could be involved in some patients, and therefore, their responses might be different.

We know that this chemical called CGRP has been studied and investigated aggressively over about 20 years. We now have several medications targeting CGRP. But as important as it is, it may not be as important in every patient with migraine.

There might be other mechanisms involved in some patients. That may require a different treatment or a new treatment. So, yes, we frequently see patients who need to have either medication adjusted or even try something completely different, just looking at different patterns.

Synergy Integrative Headache Center Founder & President Dr. Alexander Feoktistov

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How Abbott engineered a catheter-delivered device for premature babies Abbott ’s experience designing its Piccolo device provides essential lessons for medical device creators who want to spark a pediatric medical device renaissance.

Amplatzer Piccolo PDA treatment device Image courtesy of Abbott

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Danielle Kirsh | Senior Editor |

he Amplatzer Piccolo occluder from Abbott is one of the first medical devices that health providers can implant in premature babies weighing as little as 2 lb to treat patent ductus arteriosus (PDA) in a minimally invasive way.

PDA is an opening between two blood vessels leading from the heart. It is one of the most common congenital heart defects in premature babies and accounts for up to 10% of all congenital heart diseases.

Approved by FDA in early 2019, Piccolo is a self-expanding, wire mesh, catheter-deployed device inserted through a small incision in the leg and guided through vessels to the heart, according to Abbott. The Abbott Park, Ill.–based medtech giant designed Piccolo to allow a physician to insert it through the aortic or pulmonary artery with the ability to retrieve and redeploy the device for optimal placement.

Because of the device’s small profile and its small market, the engineering www.medicaldesignandoutsourcing.com

behind the deploying catheter and device’s material can significantly impact its efficiency.

“The design of the catheter is an interplay of multiple factors,” Santosh Prabhu, head of R&D for Abbott’s structural heart business, told Medical Design and Outsourcing. “You need to pick the right materials for designing the catheter, construct it the right way and put in the right steering mechanisms so you’re able to deliver it through a narrow, tortuous blood vessel. You need the right combination of the stiffness of the catheter mixed with the flexibility.”

The anatomy of a neonatal child is not well established, Prabhu said. Nitinol — the material used in the Piccolo — has shape memory and elasticity. Nitinol has the unique ability to allow the device to collapse down to deliver it through a narrow catheter. Once it’s in the deployment, the physician can release the implant, which will return to its intended shape with the body’s temperature.

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TUBING TALKS

“Pediatrics are the most difficult environments to work in because everything is on a small basis,” said Mike Dale, SVP of Abbott’s structural heart business. “There’s a lot of real estate to work with in adults, so you can imagine what it’s like working with premature babies that literally fit in your hand.

Whatever catheter might work in us is simply a non-starter for babies.”

Supporting an underserved market When asked about recent pediatric device innovations, Dr. Gwen Fischer quickly mentioned Abbott’s Amplatzer Piccolo occluder. Fischer is director of the Pediatric Device Innovation Consortium, as well as pediatric extracorporeal membrane oxygenation (ECMO) director at the University of Minnesota Masonic Children’s Hospital.

Pediatricians need even more devices for children such as the Piccolo to hit the market, because innovations in adult medical devices have outpaced

the pediatric market for years, according to Fischer. The small pediatrics patient population is underserved, and pediatric device developers often face challenges with funding and engineering. The market’s small size can hinder innovation and suppress an investor’s bottom dollar.

Physicians and surgeons often have to use products that aren’t approved for use in children. Sometimes they use a liver stent made for adults as a heart valve in kids. They could also use a product that is technically sized for a child but may not have gone through lengthy and costly clinical trials.

“When you’re trying to build something for such a small population, you need to be

Image courtesy of Abbott

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able to test it in clinical trials, and there just aren’t as many patients available for those clinical trials as there are in adult trials,” Fischer said. “It can be very difficult and expensive to run those clinical trials to make sure the device you’re making is safe and effective.”

A pediatric heart valve could make $10 million to $50 million in sales depending on what the device is, Fischer said. But the adult heart valve market is between $100 million and $1 billion depending on the device. The funding for pediatric medical device development boils down to whether investors want twice their money or 10 times their money.

However, with a smaller market comes fewer investors, according to Fischer.

“It’s harder to find investment funding for those projects because you know the return on investment is going to be much lower than it would for an adult product,” Fischer said. “It’s not because they don’t support pediatrics because a lot of [investors] are very supportive of pediatrics in

Pediatrics are the most difficult environments to work in because everything is on a small basis.

There's a lot of real estate to work with in adults, so you can imagine what it's like working with premature babies that literally fit in your hand.

other ways. Most of them are beholden to shareholders or people that contributed funds. It’s just sort of the way of the world.”

Dale at Abbott said: “All the patients you want to treat are a smaller population. So, it’s a very high investment for a very small target population.”

“It’s difficult to organize the capital resources to do work in the pediatric area because there’s a high failure rate with your attempts and the actual markets are relatively small,” Dale said.

Pediatric devices can be difficult to engineer because children pose a unique challenge: They’re still growing. Their immune systems are constantly changing, their inflammatory markers change over time and their ability to clot and coagulate changes as well.

“If you’re trying to build a heart valve for a kid when they’re 3, it’s going to be a different size when they’re 13,” Fischer said. “Those things can often be a bit of a barrier when it comes to pediatric medical device development.”

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TUBING TALKS

Image courtesy of Abbott

The market, though, is not as bad for noninvasive devices for children, according to Fischer.

“Things that we consider to be … an FDA-cleared product, the barriers to those are less now because you don’t necessarily have to do a clinical trial. You just have to show that you’re making it safely. It’s easier to get out something like a pediatric toothbrush than a heart valve.”

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Kickstarting a pediatric medical device renaissance Even with the small market, Abbott proceeded with the Piccolo because there was so much potential to improve patients’ lives — the company’s mission, Dale said.

Abbott isn’t alone in building medical devices specifically for kids and pediatric diseases rather than miniaturizing an adult product for a child. For example, Fischer pointed out Preceptis Medical’s secondgeneration Hummingbird tympanostomy in-ear tube system that is designed for inoffice pediatric tube procedures without the need for anesthesia.

The FDA has done a lot of work to make it easier for companies to enter the medical device space. It has created a nationwide funding program and a consortium program that sponsors several pediatric medical device consortiums across the U.S. and funds pediatric medical device contracts. The FDA also connects industry professionals and people who know how to commercialize a device to help inventors bring their own devices to market. The agency states on its website that it is increasing the number of medical devices with labeling for pediatric patients by incorporating more known information about device effects in other patients to support more pediatric indications.

“I think we’re headed into a pediatric medical device renaissance of sorts,” Fischer said. “A lot of the lowhanging fruit has been picked when it comes to cardiac and other neurological areas. I think companies are looking for opportunities that are profitable, and there is a lot of profitable opportunities in pediatrics. It may not be 100 times your investment, but you’re going to have a return on investment.”

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his year is seeing a wave of expansions by medtech contract manufacturers in Costa Rica.

Medtech OEMs have made the Central American company a manufacturing hub since the 1990s. Major companies operating there include Abbott, Bayer, Boston Scientific, Cardinal Health, Edwards Lifesciences, Hologic, Medtronic, Philips, Smith+Nephew and Wright Medical.

Eight of these are among the top 20 exporters in Costa Rica, representing nearly $2.7 billion in medical device exports in 2019 — 73% of the total.

Medtech OEMs in Costa Rica want their suppliers nearby, making the Central American country a magnet for contract manufacturers. The addition of medtech sterilization facilities in Costa Rica — BeamOne (now Steris) in 2009 and Sterigenics in 2013 — also helped spur more contract manufacturing.

Before that, manufacturers had to ship products to the U.S. for sterilization, according to Pilar Madrigal, director of investment advisory for CINDE, Costa Rica’s investment promotion agency.

Why Costa Rica?

The Costa Rican government has worked hard to attract and keep medtech companies, which value its political and economic stability, tax incentives and highly educated workforce. The government abolished its military in 1948 following a civil war, turning its attention toward developing political stability and promoting education, environmental protection, public health and national and cultural preservation.

The absence of an army makes it possible each year to fund all the country’s public universities, Madrigal told Medical Design & Outsourcing in a recent interview.

Costa Rica offers tax incentives for foreign manufacturers under the Free Trade Zone Regime, a law that exempts companies from a high percentage of income taxes, export and import duties, municipal and value-added taxes, depending on the size of their investment in the country.

“It really covers a whole scenario that pretty much can give you tax-exempt status for at least eight years,” Madrigal said. “If the companies reinvest and continue to grow and reinvest in other types of processes or the same ones, they can submit for a renewal of those tax advantages. Companies have been operating under that fiscal regime for years.” www.medicaldesignandoutsourcing.com

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COSTA RICA

Costa Rica also has free trade with the U.S., China and the European Union.

Most of the foreign companies with operations in Costa Rica hail from the U.S. and ship most of their products there, Madrigal said. But even that is changing, with some companies exporting to the Netherlands for shipping to the rest of the EU and even Asia and Australia.

The tax incentives are great, but several contract manufacturers told MDO that the quality of employees, their education and training, are the main attraction. Costa Rican children learn English beginning in kindergarten, another incentive to attract U.S. companies, according to Madrigal.

“It’s a great opportunity in terms of ROI, but most of them talk about the talent,” she said.

Looking back and ahead Bob Stoesser knows that well. Stoesser’s California contract manufacturing company had a customer (ArthroCare, since acquired

by Smith+Nephew) set up a device assembly operation in Costa Rica and wanted to develop a local supply chain.

Stoesser told MDO that he worked with a good friend who had a molding factory in Costa Rica to open his own site in 2003.

Contract manufacturer SMC (Somerset, Wis.) bought Stoesser Industries in 2008, making Stoesser a vice president. SMC’s customers include some of the largest OEMs in Costa Rica, and the company also does finished device manufacturing there for export to the U.S. SMC employs more than 200 people in Alajuela, Costa Rica, and is poised to invest at least $20 million to double the size of its assembly and injection molding operation there to 120,000 square feet. It’s the company’s third expansion there in 10 years.

Images courtesy of CINDE

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www.medicaldesignandoutsourcing.com

“I feel safe to say that this latest investment and expansion is not our last in Costa Rica,” Stoesser said. “We see that growth happening on a continuous basis, and other OEMs continue to move the operations down to Costa Rica. They need our support. It’s a good thing.”

Anthony Amador has been president of interventional device manufacturer Biomerics’ facility in Cartago, Costa Rica for eight years, including under different ownership. But he’s been working in medtech there for 20 years and has seen many changes.

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COSTA RICA

“Even with the COVID pandemic we have been going through, medical device has been expanding,” Amador said. “All the companies have been expanding, hiring. I think for the future, it’s going to grow a lot more.”

Biomerics has been in Cartago for six years. It previously expanded from 20,000 to 50,000 square feet and is now building a 100,000-square-foot factory there.

The Salt Lake City–based company initially kept its Costa Rica production to legacy parts, contrast media and anesthesia lines — high-volume, high-labor manufacturing that costs less than in other countries. Now it’s advancing technical capabilities there to include tubing extrusion, injection molding, laser processing of metals and advanced catheter shaft production, according to sales and marketing director Chris Richardson.

More expansions Here are some other contract manufacturers expanding in Costa Rica: •

Freudenberg Medical (Beverly, Mass.) is adding 8,600 square feet to its Alajuela factory, including an additional ISO Class 7 cleanroom for catheter manufacturing and assembly, molding, extrusion, and packaging, as well as added office space. Freudenberg opened a shared service center in Alajuela in 2020 to provide specific IT and accounting services for its North American operations. “It has proven to be an excellent location to hired skilled people in IT, in accounting, on the engineering side,” said CEO Max Kley. “We are very happy with the quality of talent that we’ve been able to bring on board.”

Even with the COVID pandemic we have been going through, medical device has been expanding. All the companies have been expanding, hiring. I think for the future, it's going to grow a lot more.

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COSTA RICA

SMC employs more than 200 in Alajuela, Costa Rica, and is poised to invest at least $20 million to double the size of its assembly and injection molding operation there to 120,000 square feet.

Images courtesy of SMC

•

Laser micro manufacturer Resonetics (Nashua, N.H.) set up shop in Costa Rica in 2016. Its factory in the Coyol Free Zone business park in Alajuela has become the company’s highest-producing site, operating 24/7 and focusing on high-volume component and sub-assembly production for export and for the local medical device industry.

Resonetics announced in April that it has leased more space in the Coyol park to more than double its production there. Employees there are fabricating components, mainly using laser processing, cutting, blading and welding. The expansion will allow Resonetics to add centerless grinding capabilities and nitinol processing, according to CEO Tom Burns. “I think Costa Rica is only getting more attractive,” Burns said.

“Success begets success.”

•

Viant Medical announced in April that it has completed a major expansion of its manufacturing facility in Heredia. The expansion adds 14,000 square feet of ISO Class 8 cleanroom molding and assembly space and repurposes 16,000 square feet of additional warehouse, office and support capacity, for a total of 180,000 square feet across four buildings.

Viant added 15 molding machines and two-shot molding capability, which complements the liquid silicone rubber molding operation added in 2020. The company www.medicaldesignandoutsourcing.com

expects to add 300 jobs through 2021. The expansion and hiring will cost up to $4 million. “The primary (reason) is their intellectual capital,” COO Sean Crowley said of the company’s decision to expand in Costa Rica. “The capability of the employee base down there is significant.”

Crowley added that the country has more to offer medtech companies including sterilization and trained employees. “It’s just not something that you could find if you were to move to another country with lower-cost labor.”

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How contract manufacturer decided to make its own medical device Medtech contract manufacturers such as Minnetronix often avoid making their own devices.

But CEO Jeremy Maniak had a different idea.

TO M S A LEMI D E VIC ETA LK S ED ITO R IA L D IR EC TOR

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innetronix Medical (St. Paul, Minn.) is closing on its quarter century mark, and Jeremy Maniak has been with the company more than half of that time.

Promoted into the corner office in early 2020, he has some unique ideas about how to position the medtech contract manufacturer for growth over the next 25 years.

An electrical engineer who entered the medical device industry directly out of Purdue University, Maniak explained to our DeviceTalks Weekly Podcast about how Minnetronix saw an opportunity to create its own line of medical devices.

It’s an unusual strategy as CMOs work for companies that also make devices, but Minnetronix sees the effort creating a new opportunity to partner with those same medical device companies.

Minnetronix already has established itself as a contract manufacturer with a focus on four core technologies — radio frequency, electronic magnetics, optical

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device and fluid and gas management. And the company has innovated well. Its first product — the MindsEye Expandable Port for minimally invasive deep brain access — earned the “Best New Technology Solution – Surgical” award from MedTech Breakthrough, an independent market intelligence. Meanwhile, Minnetronix’s second neurovascular product is still passing through regulatory inspection.

The following Q&A represents only a portion of the interview. It has been edited heavily for presentation and clarity.

DTW: When did you first contemplate developing your own products?

Maniak: When I joined the company, my mission was to identify whether there was an opportunity to [develop niche products.] We wondered if there are some other things we can do to help customers grow their businesses and ultimately help patients and doctors. www.medicaldesignandoutsourcing.com

Minnetronix’s first product — the MindsEye Expandable Port — earned the “Best New Technology Solution – Surgical” award from MedTech Breakthrough, an independent market intelligence.

Image courtesy of Minnetronix

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MINNETRONIX

of this sort of work for customers in different segments of medical technology.

Then we also brought in some key folks around regulatory. We have a really nice partnership with Dr. [Andrew] Grande of the University of Minnesota as well as neurosurgeons from across the country.

“We needed to expand, but at the same time we wanted a place where culturally our employees want to be,” Minnetronix CEO Jeremy Maniak said of the company’s headquarters campus renovation.

DTW: What was the genesis of this program?

Maniak: We really saw it as an opportunity to fill what we consider to be an innovation gap in middle markets of the medical device space. In this case, it’s in the neuro ICU space. We wouldn’t try to innovate in diabetes or cardiology, those big spaces with tons of venture capital and OEMs that are actively innovating in the space. We saw a gap in [products] with markets in the $500 million dollar range.

DTW: Developing your own line of products sounds transformational for a contract manufacturer. How do you see it?

Maniak: We see it as additive. We see it as an extension of what we do today.

We're not trying to shift from one business to the other. We view as an extension of our relationship with our partners. We don't really have the intention to sell commercially at scale. We don't have a direct sales force to the hospitals. We're not planning necessarily on building one.

That’s where we work with our partners.

DTW: Do your customers see a conflict in you developing your own medical devices?

Maniak: If we were competing in the sales channel against them, it’s possible. We're not trying to compete with them. That's not the purpose here. The purpose here is to give our partners more things to help their growth, which helps our growth and then helps patients. So it's pretty symbiotic.

Some people have tried this in the past.

That’s been more of a competitive thing.

Competing with customers doesn't work.

And that's not what we're doing.

DTW: Would you develop products that require a 510(k) or PMA? Maniak: I think the PMA timelines are so long, and it actually undermines our middle market funnel a little bit. They just need to be really big opportunities to support the cost of a PMA.

DTW: How did you create the innovation infrastructure? Did you look internally or externally?

Maniak: Both. We definitely had some engineers here that were doing some

WHY MINNETRONIX MADE ITS OWN MEDICAL DEVICE. In a recent DeviceTalks Weekly Podcast, Minnetronix CEO Jeremy Maniak explained how the CMO is using internal know how to develop medical devices that can be sold by outside partners. We also hear from Dr. James Min of Cleerly Health about that company’s start and the process that went into raising $43 million. www.devicetalks.com/podcast/

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MINNETRONIX

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DTW: What has this program taught your employees?

Maniak: We are in the contract business, the partnering business. I think it's helped them put our customers’ challenges into context.

They know what our customers are challenged with. They got to see that, `Hey, when we did it ourselves, where we have the same challenges and those are real challenges.’ I think it helps us work with our customers better across all of our products. It's about how could we help you figure this out. It changes the conversation.

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DTW: What has surprised you?

Maniak: It’s actually created some interesting discussions with customers and new customers that I wouldn’t have considered before like venture capitalists who are asking if they were to give us an idea from their think tank could we then create the product for them. They would obviously own the IP.

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DTW: Finally, this is more of a bricks and mortar question. Your recently renovated headquarters looks sharp – basketball courts, cool workspaces – what does it say about where Minnetronix is headed?

Maniak: We needed to expand, but at the same time we wanted a place where culturally our employees want to be.

It promotes collaboration, promotes innovation, promotes unity, and working together to solve the tough problems that exist with working with these technologies.

Now we have someplace we can bring customers, and they can feel that same vibe. They can play basketball over lunch.

They want to come in and partner with us. We want it to be fun, and we want an environment that really is engaging for them and our teams to, to work on these problems together.

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OncoRes Medical CEO Dr. Katharine Giles (left) and Dr. Christobel Saunders (right), who helped create the technology behind the company’s handheld imaging system.

Image courtesy of OncoRes Medical

OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery.

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Australian startup OncoRes Medical won FDA breakthrough device designation in October 2020 for its handheld imaging device designed to www.medicaldesignandoutsourcing.com

identify residual cancer cells in breast tissue after the surgeon has removed a tumor but before concluding the procedure. The idea is to enable surgeons to remove all cancer on the first try, thus avoiding a second procedure.

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BREAST CANCER TREATMENT

The problem Breast imaging has greatly improved over the past two decades, but identifying malignant cells left inside the surgical cavity during breast-conserving surgery has remained a significant challenge. Today, patients and surgeons have to wait several days after the surgery for pathology results to reveal whether residual cancer was too close to the margins of the excised tumor. If tumor cells are found to be too close to

was significant. The researchers called for further efforts to lower the rates more.

How OncoRes’ device works Medtech has produced other devices to help identify residual cancer cells, but OncoRes’ device can do it quickly and on a micro-scale, according to CEO Dr. Katharine Giles. It also employs an artificial intelligence (AI) reader that enhances the evaluation to deliver 100% sensitivity and 97% specificity, Giles noted.

enables the surgeon to evaluate the microarchitecture of tissue at a scale and resolution approaching histology.

The technique also enables the differentiation of multiple breast cancer types, the company said.

The OncoRes probe collects the images and displays them on a console with an imaging screen similar to an ultrasound machine. It also has a disposable component, which is fit to the front of the probe.

OncoRes’ technology combines optical coherence tomography and micro-elastography to enable real-time assessment of tissue microstructure, according to the company. The technique measures back-scattered light intensity, enabling rapid, high-resolution, 3-D imaging that can readily differentiate adipose (fatty) tissue from dense tissue. The addition of micro-elastography provides a quantitative measure of tissue stiffness that enables surgeons to distinguish healthy dense tissue from cancer better.

The combined technology, termed quantitative micro-elastography,

The path so far Dr. Christobel Saunders is a surgeon at Fiona Stanley Hospital and a professor of surgical oncology at the University of Western Australia (UWA), both in Perth. She worked with the optical engineering group at UWA for many years on precursors to OncoRes’ technology.

When Brendan Kennedy came to the department as a postdoc in 2008, he brought experience in optical coherence tomography. The two worked together on the concept for years.

Meanwhile Giles, also a surgical assistant in Perth, earned an MBA and

Combining optical coherence tomography imaging (OCT; left) with micro-elastography technologies, OncoRes’ quantitative microelastography (QME) imaging system provides real-time tumor assessment that helps surgeons more accurately identify and remove cancerous tissue.

Image courtesy of OncoRes Medical

the margins of the surgical specimen, women are left with a big decision: undergo a second breast-conserving surgery or a mastectomy.

More than 20% of patients undergoing initial breast-conserving surgery for cancer require reoperation, according to a 2019 study published in the Annals of Surgical Oncology.

The American Society of Breast Surgeons in 2015 endorsed 10 tools to lower the rate of reoperations. The study, however, found that even though the tools lowered reoperation rates among society members, the variability among surgeons 56

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BREAST CANCER TREATMENT

began working for a diagnostic startup.

Giles entered the field of venture capital in 2006 and landed at Brandon Capital Partners, Australia’s largest venture fund, in 2012. She learned about the OncoRes technology in 2013 and described it to Medical Design & Outsourcing as “love at first sight.”

“I could just see how it was exactly what surgeons were looking for,” she said.

“They were looking for more information under their control to enable better decision-making in theater and therefore, better patient outcome…

“I worked with the team for three years in terms of developing the investment case around the technology, really deeply understanding the clinical needs,” Giles added. “And then Brandon Capital put a Series A investment of $4.2 million U.S. dollars in, in late 2016.”

pursue FDA 510(k) clearance but listened to the advice of the industry experts who work with MedTech Innovator contestants and decided to pursue premarket approval, the more rigorous and expensive path.

Looking ahead Others are working on different types of imaging technologies to scan the cavity for microscopic cancer cells during surgery, but are using tissue biopsies and different ways of detecting the cells, according to Grand.

“This kind of tool is completely different,” he said. “It doesn’t require huge capital equipment.

It’s going to be more accessible because it won’t have huge costs associated with it.”

I could just see how it was exactly what surgeons were looking for. They were looking for more information under their control to enable better decision-making in theater and therefore, better patient outcome.

The company raised another $1 million USD in March 2020 and landed $6.8 million USD in grants from the Australian government.

Seeking a market in the U.S. The team at OncoRes set their sights on the faraway U.S. market. They made connections through Brandon Capital’s Palo Alto office and entered the MedTech Innovator contest in 2019, placing second. OncoRes also won that contest’s value award as the company with the most compelling value proposition.

OncoRes’ technology presents a huge economic and patient benefit, according to MedTech Innovator CEO Paul Grand.

“This company was really one of the most likely companies to succeed,” Grand told MDO. “Just getting selected to the finals means that they not only had the promise but they had the goods. And the team is a big part of that, too.”

The OncoRes team had planned to

Meanwhile, OncoRes officials believe they’ll need to raise $45 million to $50 million USD over several rounds to get the company all the way through to FDA approval.

Now OncoRes’ chief medical officer, Saunders believes that if approved, the device could halve the rates of second cancer surgeries.

Said Giles: “What we’re hoping to do is be to be able to give patients and surgeons the confidence that it’s all gone.“

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S EAN W H O O LEY AS S O CI ATE ED I TO R

How PhysIQ is advancing digital therapeutics through its partnership with Janssen A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform.

O

ver the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount.

Virtual care became the norm after the COVID-19 pandemic hit, and, although a return to something resembling “normal” could be on the horizon, those at artificial intelligence– based technology developer PhysIQ see that the landscape has been reshaped since early 2020.

“Digital medicine has been evolving but a lot of what’s been done has been done in an exploratory capacity,” PhysIQ CCO Chris Economos told Medical Design & Outsourcing and MassDevice. “COVID-19 has definitely changed that.”

In the throes of the pandemic in September, PhysIQ was among a number of companies to receive government contracts to aid in the battle against COVID-19.

Economos called the recent shift toward digital health as a representation of what

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companies like PhysIQ have set out to do.

With the opportunity to demonstrate how its technologies can move healthcare forward, PhysIQ found itself helping to address a global pandemic.

The company’s latest step forward was last month’s announcement that it is collaborating to license its AccelerateIQTM platform with Janssen Pharmaceuticals, a Johnson & Johnson unit. The partnership will see the licensing of Chicagobased PhysIQ’s AccelerateIQTM to Janssen so it can deploy it to collect data across its clinical studies through a range of its wearable biosensors, while also utilizing PhysIQ’s portfolio of FDAcleared digital biomarkers and its medical-grade platform to transform raw data into clinical insight.

“I think a really important piece here is that this isn’t only exciting for PhysIQ but for our industry in general,” Economos said. “Digital has rapidly accelerated or expanded during COVID, but what this particular collaboration and deal signals is that, for Janssen, they realized that this is not something that’s just relegated to exploration anymore.

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They needed something that was really going to scale across the enterprise. For all of us involved in digital, I think that’s a really exciting thing.”

Economos describes PhysIQ’s platform as device-agnostic, as its capabilities range from working with wristbase wearable sensors to patch-based wearable sensors. The company’s aim is to provide an option that works with any kind of sensor a customer might need.

The company’s focus is to use a particularly unique IT platform to collect data over days, weeks, months and even years before its portfolio of digital biomarkers or analytics take the sensor data and produce clinical insight. Machine learning and AI are then used to take the data streams and turn them into something useful for researchers or clinicians.

selected our platform. They’re looking for what I’ll call a future-proof platform that is flexible and can scale as their needs scale across the enterprise. That scalability is a really important piece in all this.”

PhysIQ’s partnership with Janssen will potentially see its platform placed across all the platforms the J&J unit works in, including neuroscience, immunology and oncology — and possibly even with the company’s single-dose COVID-19 vaccine, one of just three vaccines authorized for emergency use by the FDA in the U.S. Janssen can utilize the platform to collect real-world data through the sensors on the R&D side to support clinical development and drug development, as well as on the commercial side with the integration of digital medicine into their commercial strategies, Economos said.

“Pharma is one part of our business but we also sell our solution to what we call the healthcare vertical, where we sell it to payors and healthcare systems.

“The things we’re focused on or the things that pharma is focused on in terms of using wearable sensors in a clinical context, we’ll see in actual patient care. That’s one of the things we’re really excited about — this evolution from using sensors in R&D to using sensors to support patients as they’re on drugs and they’re accessible by the healthcare provider as well.”

Scott Thielman, the CTO of product development consultancy company Product Creation Studio, said that players in the space like Janssen are looking for platforms like what PhysIQ offers: those that can are “far abstracted beyond the concepts of cloud, edge processing and wireless links” upon which they can build.

“There’s multiple dimensions of scalability, one of which is being device agnostic and the other obvious one is being able to handle patient volume,” Economos said. “There are others like the ability to deploy new algorithms as they come online. This is what I believe Janssen was focused on when they

The groundwork has been laid for the partnership to utilize PhysIQ’s platform in the present, with eyes set on what can be done in the future, too.

“The long-term will see a convergence of using digital for drug development and pharma use cases with actual patient care,” Economos said.

Image from PhysIQ

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PHYSIQ

Image from PhysIQ

“Collection and management of clinical study data is an incredibly important operation that happens to lie just outside of the development activities that most drug companies really want to focus their internal resources on,” Thielman said. “The data itself is a precious, high-value asset so it makes sense for players like Janssen to choose a best-inclass partner platform. There will continue to be a role for PhysIQ and similar companies that bring insights to their customers rather than just data aggregation. “ While the circumstances were unpredictable amid the pandemic, Economos said the company has been excited to showcase the ways in which PhysIQ can address the unmet needs that have been presented over

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the past 14 months or so.

Pairing with Janssen to demonstrate the effectiveness of its platform only further highlights the medical space’s move toward digital therapeutics.

“There’s the obvious implications of establishing an enterprise deal with such a large organization. But beyond just the platform piece, we also see the opportunity to collaborate on co-development of new digital biomarkers, working with our pharma clients to accelerate our ability to get new digital biomarkers to market faster,” Economos said.

“By virtue of the number of therapeutic areas that Janssen focuses on and the number of patients that interact with their products, this is a really exciting opportunity to advance digital medicine alongside them.”

DEVICETALKS

Martha sets 800 million patient mark for Medtronic Can Medtronic really reach 10 times as many people as it does today?

To m S a l e m i | D e v i c e Ta l k s E d i t o r i a l Director |

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n an interview with DeviceTalks’ special MedtronicTalks podcast series, Geoff Martha says one year in the CEO seat has shown him the company is positioned to have a far greater impact on global health than it currently does.

“We take great pride in that we impact the lives of two patients every second,” Martha said. “That sounds like a lot. Two patients every second adds up roughly to 80 million people per year. But … 80 million is just a small fraction of the world’s population. We tend to deal with the sicker people that need a cardiac device or a surgical procedure.”

Martha said with advances in miniaturization, artificial intelligence, longer battery life and other areas, Medtronic is positioned to develop products that help millions more.

“We should be much more ubiquitous given advancements in technology and the role that we can

7 • 2021

play in healthcare,” Martha said. “I really think we could get that to 800 million in a reasonable period of time.”

The moonshot suggestion fits into the new hungry “Medtronic Mindset” that Martha and the company’s management team are trying to instill in the workforce.

The company has placed greater emphasis on gaining market share in the areas it operates – either by grabbing business from competitors or growing markets by creating products that can deliver new treatments.

Two immediate ways that Medtronic could extend its reach are the rollout of its Hugo surgical robot, as well as its Symplicity Spyral renal denervation system to lower drug-resistant hypertension. The technologies still require U.S. regulatory approval.

But the company has had setbacks.

Martha shed some light on the decision to pull its HeartWare HVAD system off the shelves. HeartWare

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accounted for less than 1% of Medtronic’s revenue, according to Truist Securities. But Medtronic did pay $1 billion to acquire the company and device in 2016.

The decision left Abbott International as the sole LVAD provider with its HeartMate 3.

“What really drove the decision was there was a growing body of evidence that Abbott’s device was better for patients,” Martha said, explaining that patients with Medtronic’s device suffered higher rates of stroke and death than Abbott’s.

“We just felt it was better for patients” to withdraw HeartWare, Martha said. “It goes straight to the heart of Medtronic’s mission-driven focus. We’re disappointed we couldn’t address some of the issues. It’s a complicated therapy. We couldn’t get it to where we want it … the path was uncertain.”

At the end of the day, Martha said the decision wasn’t hard. “Our reputation is the most important thing here at Medtronic and our mission. This is the right thing for patients.”

We take great pride in that we impact the lives of two patients every second. That sounds like a lot. Two patients every second adds up roughly to 80 million people per year. But...

80 million is just a small fraction of the world's population.

Listen to this MedtronicTalks podcast — and much more — at devicetalks.com

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