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Articles from 2020 In October

Let’s Talk Medtech

Boston Scientific's Sandra Nagale Guest Stars on Let's Talk Medtech

Digital health has been a hot topic this year as COVID-19 has served as a catalyst to digital health technologies. But as Sandra Nagale, PhD, points out in this episode of Let's Talk Medtech, the industry was already on a good trajectory toward preparing for this world-changing pandemic, thanks to the evolution of digital health. Because of that evolution, companies like Boston Scientific were well positioned to deploy new digital solutions in response to COVID-19.

Nagale, director of digial health and data services at Boston Scientific, will deliver a keynote Thursday during the BIOMEDigital virtual conference. Click here for more information and to register for the event.

In the episode below, you'll also hear Nagale talk about how Boston Scientific is using digital innovation to enable rapid problem-solving across the company.



At BIOMEDigital, Nagale — interviewed by Jennifer Joe, MD, a nephrologist and ER physician — will explore:

  • Transformation of healthcare to digital, including device trends, challenges, and opportunities
  • Evolution of medical devices and wearables, sensors, and data analytics in a proof-of-concept clinical study
  • Leading technologies that enable these devices, such as the development of HeartLogic, a highly sensitive predictive algorithm for heart failure events that essentially uses artificial intelligence to translate data from sensors in embedded cardiac rhythm devices to predict heart failure weeks before it happens, providing physicians with the potential to intervene
  • Patient / user centricity: Recent success and increased adoption (like the Boston Scientific's Ask Angie platform, an augmented reality tool that was in use for several years but quadrupled early in the pandemic when access to hospitals was limited)
  • Importance of health equity

Can a Robot Make a Better Heart Valve?

paul - IMG_Oct302020at12842PM.jpg

Calcification is the bane of the human heart valve. Human heart valves are plagued by stenosis1 – or the thickening or stiffening of the valve leaflets caused by a build-up of calcium. Millions of patients are affected each year.2 A patient with a stenotic valve needs a replacement valve at some time in their life or their heart valve will fail and they will die.2 This issue has driven the growth of the artificial heart valve industry over the last several decades.

Several types of prosthetic valves have been invented over the last 70 years, but none have adequately resolved the problem of heart valve calcification without significant trade-offs.

Types of prosthetic heart valves

Mechanical heart valves – commonly made of carbon today - were invented in the 1960’s. While very durable, often lasting throughout a patient’s lifetime,3 they require open-heart surgery and the carbon surface attracts blood clots.4 As a result, patients with mechanical valves must be on lifelong blood-thinning medication5 (anticoagulants) to prevent the development of blood clots that can cause a heart attack or stroke. This use of blood thinners puts patients at a high risk of bleeding6 and they must often compromise their lifestyle to accommodate it.

To reduce this risk of valve thrombosis and lifelong use of blood thinners, tissue heart valves were invented, commonly using bovine (cow) or porcine (pig) tissue for valve leaflets. While reducing the risk of thrombus,4 the animal tissue proved far less durable than mechanical valves, often requiring a re-operation to replace the valve within 10 to 20 years.3 Tissue valves are also complicated to manufacture. According to Edwards Lifesciences,7 one of the world’s largest heart valve manufacturers, making just one of their tissue valves takes 150 employees, 40 days of production, and 5-6 weeks of testing and packaging, with each assembler requiring 6 weeks of training.

As an alternative, polymer valves have been explored over the years. However, polymer valves have been unable to demonstrate that they can withstand the stresses of a human heart valve and have suffered from calcification, thrombosis, and lack of durability.8

So, there exists a conundrum in current commercial heart valves - making tradeoffs in durability for patient quality of life – resulting in no heart valve that checks all the boxes.

Making a better heart valve

What if, rather than iterating off existing ideas to solve the challenges around heart valves, you instead decided to rethink everything about a heart valve from scratch…what would you end up with?

To start with, you would simultaneously think about material, design, and manufacturing to optimize everything about the device and its production.

You would start with finding or inventing a material and design that could resist calcium and withstand the stresses and strains of the human heart for a lifetime. One that virtually eliminated thrombus accumulation and pannus formation on leaflets. One that required only one surgery for any given patient. And one that matched or improved upon the performance of today’s standard-of-care heart valves.

At the same time, you would identify a manufacturing process that could accommodate that material and design while improving uniformity and precision, streamlining the process, and reducing costs associated with tissue valve manufacturing. Oh, and you would also want to be able to run the line 24 hours a day, 7 days a week, and not be sidelined by pandemic concerns.

Purpose-built material and design

Carbon, tissue, and polymer have all shown weaknesses as surrogates for the human heart valve. All of these approaches have used existing materials and altered them to withstand the significant pressures of the human heart.

Only by creating a brand-new material can we hope to finally solve the historical heart valve conundrum. By engineering a biopolymer at a molecular level specifically for use in the human heart (LifePolymer™*) we can finally end up with a valve that can withstand and even go beyond the substantial stresses the human heart can produce.

With a proprietary biopolymer, you can design ultra-thin yet strong leaflets that can rapidly open and close, enabling excellent hemodynamics.9 You can also computer-design the leaflet shape and stent design uniquely for the aortic and mitral positions to accommodate the different opening and closing dynamics for each position. This approach is designed to optimize the distribution and absorption of stress in a bid to enhance durability.

Using this novel biopolymer and valve design, early animal studies and bench testing have shown promising results. Animal studies have shown no calcification,9 virtually no platelet aggregation,9,10,11  negligible fibrin deposition,9,10,11  no pannus formation on leaflets,9,10,11, and excellent hemodynamics.9 Internal bench testing has shown resistance to catastrophic valve deterioration (even to deliberately-damaged leaflets).12,13,14,15

A Breakthrough in Heart Valve Manufacturing…Robotics

The unique material and design enable robotic manufacturing of an artificial heart valve for the first time in history. Using robotics, you open up the door to levels of precision, stability, reproducibility and efficiency that could have never been imagined with existing heart valve production.

The robotic valve dipping process using a biopolymer creates an entire heart valve leaflet and frame structure in one step. This revelation was a turning point in the commitment to robotic manufacturing. The integrated material-design-manufacturing approach also enables the design of one valve base and universal tooling for all sizes of valves, which enhance the ability to robotically produce the valve.

Think about what it takes to manufacture tissue valves today. Animal tissue is first collected from slaughterhouses and then must be cleaned, sorted and sterilized. Production is done in vast rooms with hundreds of human assemblers sitting elbow to elbow, painstakingly hand-sewing leaflets to valves. Now, envision what robotic heart manufacturing looks like in the real world. Imagine three small robots with the capability to manufacture enough valves to accommodate an entire year’s worth of U.S. surgical heart valve demand (100,000 valves, to be specific).

Robotic heart valve manufacturing benefits from decades of robotics experience spent assembling miniature components for the electronics and automotive industries. The same requirements for electronics components – precision, cleanliness, efficiency – translate well to the needs of the medical device industry, where tiny devices are being manufactured to be used inside the human body.

Robots can be small in stature and are capable of very fine movements, beyond what a human can produce in the way of precision and repeatability. Considering a human hair is approximately 75 microns in width16, when you are dealing with ± 20 micron adjustments to a device, this is difficult for a human to achieve but quite easy for a robot. With human assembly, things can get missed toward the end of a shift when completing complex tasks,  while robots are consistent, every single time.

Remember we talked about dipping of leaflets as a turning point in the ability to robotically manufacture heart valves? Dipping of polymer leaflets by hand is a highly variable process – getting uniform leaflet thicknesses within specification every time is nearly impossible.  Robotic manufacturing adds more precision and repeatability to the process, with automated systems controlling the dipping, measuring leaflet thickness, and visually inspecting the biopolymer leaflets. Once the dipping quandary was solved, robotics could be embraced for virtually every step in the manufacturing process.

Ultimately, the robotic manufacturing design will encompass two clean room-style robots with dual articulating arms in the actual manufacturing cell, and one small load/unload robot that supplies the other robots with materials. The robots are pre-designed specifically for a clean room environment, with medical-grade material, paint, seals, wiring, and joint architecture borrowed from the automotive industry.

The human component in robotic manufacturing will be minimized as much as possible to remove subjectivity and enable efficiency. No human hands will touch the valve. Humans input the raw materials and supplies and monitor the robots, and the robots take it from there. The ultimate goal is complete automation and machine repeatability all the way through.

You might be wondering how tissue valve manufacturing could benefit from robotics. Tissue valves require more than 1,000 hand sutures each, which would not be compatible with a robot. Because the animal tissue itself and design are not optimized for robotics, there would not be the same opportunity to go robotic. There would be few tasks in manufacturing that could be automated, and thus, the economics would not be the same. Only by rethinking everything at the same time – material, design and manufacturing – does robotics make sense.

Technology in robotics

Robotics enable minute, precise and real-time trackability and digital data collection at every step, for every valve. Each robotic movement can be measured and recorded, from timing down to the 10th of a second to temperature to location. This rigor in tracking enables identification of important trends and assists with rapid troubleshooting. The QR code, invented by DENSO Robotics 25 years ago17 for NASA satellites, is utilized in tracking each valve through the manufacturing cycle.

The economics of robotics

When first considering robotic manufacturing of heart valves, one might think it would be expensive. In fact, the costs are quite shocking, but pleasantly so. The upfront cost of each robot is actually less than the annual minimum wage for most workers.

As far as overhead, the robotic manufacturing facility to produce a year’s worth of surgical heart valves comprises less than 4,000 square feet for everything, including storage. Compare that to an approximately 300,000 square foot tissue valve manufacturing facility, and add in the cost of utilities, gowns, laundry, and the like.

All in all, the upfront capital investment to robotically produce a biopolymer heart valve is under $2 million as a one-time cost to produce all the surgical heart valves needed in any given year, which is what most companies spend on just one clean room with nothing in it.

How robotics help in a pandemic

COVID-19 has created a great deal of angst and disruption for companies large and small. Valve manufacturing has faced challenges with protecting workers and social distancing in an assembly environment, meeting supply demands with fewer workers on the assembly line, training of new operators, and significant bioburden concerns.

As robots do not carry viruses and do not need time off, robotic manufacturing can ensure that not one day of manufacturing is missed in the event of a pandemic. It is also notable that the digital data recording even eliminates risks from paper from the system.

The future of robotic heart valve manufacturing

The pandemic has highlighted the peril of American manufacturers’ dependence on offshore manufacturing and foreign goods. As companies seek to bring manufacturing back to the U.S., robotics will play a larger role in their consideration. The robotically manufactured heart valve has been entirely manufactured in the U.S. since inception due to the improved economics offered by robotics.

Because of the efficient set-up of a robotic manufacturing pod, they can easily be replicated, based on demand. The manufacturing process is already set and the robots are already programmed; it is as easy as finding another facility and purchasing additional robots. Once set-up, the robotic manufacturing facility is adaptable, easy to learn, and user-friendly.

Over time, robotic manufacturing will continue to be economically attractive, as robots have a long lifespan and require minimal maintenance over the long term.

Robotic manufacturing of a heart valve – combined with a novel material and design - has shown that it can help solve the historical heart valve conundrum. As part of a novel approach of reinventing material, design and manufacturing, robotics has proven that it can be instrumental in producing a better artificial heart valve.


  1. World J Cardiol. 2010 Jun 26; 2(6): 135–139. Published online 2010 Jun 26. doi: 10.4330/wjc.v2.i6.135
  2. Nat Rev Cardiol 2011;8: 162–72.
  3.  American Heart Association website. Types of replacement heart valves page.
  4. Heart 2007;93:137–42.
  5. JACC. 2017 Jul 11;70(2):252-89 DOI: 10.1016/j.jacc.2017.03.011
  6. J Thromb Thrombolysis. 2013 Apr; 35(3): 312–319.
  7. Edwards Lifesciences. LinkedIn post.
  8. Expert Rev Med Devices. 2012 Nov; 9(6): 577–594. doi: 10.1586/erd.12.51
  9. Data on file at Foldax.
  10. Data on file at Foldax.
  11. Data on file at Foldax.
  12. Data on file at Foldax.
  13. Data on file at Foldax.
  14. Data on file at Foldax.
  15. Data on file at Foldax.
  16. website. Home page.
  17. website. History of QR code page.


Jason Beith, Vice President, R&D, Foldax, Inc.

Jason has over 20 years of experience in the medical device industry and is a major contributor to the invention of the Tria aortic and mitral surgical valve platforms, leading the development of the novel manufacturing and production system. Previously, he was Senior Principal Engineer in R&D with Medtronic, where he was the technical lead and inventor of the Avalus pericardial tissue valve. Earlier, Jason was involved in synthetic heart valve development for several years after receiving his PhD from the University of Glasgow. He was also a Principal Engineer within Edwards Lifesciences’ Advanced Heart Valve R&D, where he led the company’s efforts on polymer heart valve design and development. Jason has eight issued U.S. patents and numerous applications worldwide.

Peter Cavallo, Senior Manager, Robot Division, DENSO Robotics, Inc.

Peter has worked for DENSO Robotics for more than 40 years, in various capacities including sales, planning, and currently, as manager of the company’s Robot Division. Peter founded the robot sales division in 1999 when Denso decided to expand its robotic offerings to the U.S. and grew that business by almost 50x. Peter will retire this year after helping DENSO Robotics become a market leader.

David Robers, Vice President, Sales - Americas, Robot Division, DENSO Robotics, Inc.

David has been with DENSO for almost 10 years, rising from Business Development Manager to his current role leading robot sales throughout North, Central, and South America. Prior to joining DENSO, he founded three start-up companies, including Diversified Design Dynamics (engineering and machine design services), Diversified Manufacturing (parts manufacturing, product assembly, and machine build), and Robotic Systems Group (focused on robot sales and service).  David began his industrial career in the aerospace division of Cincinnati Milacron.

LivaNova CFO Steps Down Amidst Investor Concerns

Image by snowing12 - Adobe Stock LivaNova

PrimeStone Capital is getting its way on at least one of the changes it's asked of LivaNova. CFO Thad Huston is expected to resign from the company by the end of the week.

The London-based company has been under pressure from PrimeStone. The activist investor that wants to see big changes at LivaNova, including a new CEO.

"You should hire a new chief financial officer who will be tasked with restoring credibility, ensuring transparency and accountability, and making sure the capital structure is properly managed," PrimeStone said in its recent letter to LivaNova's board. "Please pick someone who is diligent, and has been CFO of a standalone company before, rather than a divisional controller. One cannot afford more inexperience."

LivaNova Huston joined LivaNova after more than 25 years at Johnson & Johnson (J&J) where he most recently served as CFO of the J&J's medical devices group. He also held several other senior financial positions at J&J, mostly on the pharmaceuticals side, according to Huston's bio page on LivaNova's website.

Alex Shvartsburg has been tapped as interim CFO while the company looks for a more permanent replacement. Shvartsburg is currently LivaNova's corporate VP of financial planning and analysis and the international region. CEO Damien McDonald said Shvartsburg is "deeply familiar" with the company's strategy and businesses, having worked at LivaNova since 2017.

PrimeStone has also questioned whether or not LivaNova has the right board chairman. The investor pointed out in its letter to the board that Daniel Moore has served as chairman since the 2015 merger of Sorin and Cyberonics that resulted in LivaNova.

"We believe that the board must urgently review its own performance and that of management in the most honest and dispassionate way," PrimeStone said. "From our perspective, you have collectively failed to deliver value and made significant mistakes. This started with the merger five years ago, continued with disappointing execution monitoring, sloppy covenant and balance sheet management, and culminated in a disastrous refinancing this June laying bare severe deficiencies in capital markets management."

Let’s Talk Medtech

Diving in to Address PPE Shortages

Image courtesy of Reusable and Sanitizable PPE_1web.jpg

One of the positive developments to unfold during the COVID-19 pandemic has been the incredible work to meet urgent needs for medical supplies. The non-profit is one such effort, and it has taken a creative approach to filling gaps in personal protective equipment (PPE) supplies, in both device design and business strategy. The project also serves as a blueprint for innovators and startups on how to innovate quickly while developing viable manufacturing and regulatory pathways to market.

“The early days of were a little bit chaotic,” recounted Sanjay Vakil, executive director for Working in Boston as a senior product manager in software development at Google, he had heard about a pair of anesthesiologists working at Brigham and Women’s Hospital who were looking to adapt a snorkeling mask into a solution that could provide some sort of protection. Those doctors, Alex Stone, M.D. and Jacqueline Boehme, M.D., had emailed another Google product manager, Eugene Mann, who in turn reached out to the engineering community within Google, and that’s when Vakil decided to “jump in to figure out how to help." 

Vakil and Stone will join a few other members of the team during the upcoming BIOMEDigital virtual event in the November 4 session, Heroes of Manufacturing - Boston Non-Profit Aids in Fight Against COVID-19 with Unique Reusable Face Shield. Also speaking are Devon Campbell  (Founder of Prodct as well as CPO, Head of R&D, MyBiometry) and Jon Speer  (Founder and Vice President of QA/RA, Greenlight Guru). MD+DI spoke with Vakil, Campbell, Speer, and another member of the team, Ken Block, president of Ken Block Consulting.

“One of the amazing things about this group is that it’s not a team flush with medical device engineers and experienced medical device executives,” Campbell told MD+DI. “It was an organization of people rising to the occasion, and they were from all sorts of different industries—from Google, from the CAD and drafting industry, from design teams, just all over the place. People were just helping and doing what they can during the front of the pandemic when a lot of people were in this fevered state to figure out what they can do to help and make a difference.” (To learn more about how the team members worked together, how they worked with clinicians to test their designs, how they raised donations, and what their potential plans are for the future, please check out our podcast below.)

Eventually Vakil and his initial team got to the point where they needed to bring in medical device expertise, Campbell said, particularly when it came to medical device development, regulations, and quality systems, and that’s when he got involved. Block then joined and helped the team understand FDA, CDC, and NIOSH definitions and expectations for face masks and shields and adapt its regulatory strategy to comply with an FDA EUA for face shields. “The product design didn’t change, but what changed is how we talked about it . . . and how we fit it into the regulatory environment,” Vakil told MD+DI.

Following Stone’s and Boehme's original vision, “the design is an extension of an existing full-face snorkel,” explained Vakil. “The full face snorkel . . . consists of a piece that covers you from the top of your forehead to underneath your chin, and that entire section is clear. To help you breathe, it has a snorkel that sticks out the back—you look like an giant underwater unicorn with your horn facing the wrong way.” Such snorkeling masks are designed to be air and watertight, with a removable snorkel sealed with a pressure-fit O-ring. “What we did is we removed the snorkel and made an adapter that fit onto the same port as the snorkel and took advantage of the same geometry, the same O-ring, and the same fitting capabilities, and narrowed the port down to fit an anesthesiology or circuit tube filter. . . So rather than breathing in and out of a snorkel, you are breathing through the filtered mechanism through these circuit filters.” They also blocked the mask’s original purge valve near the chin, “so the only way air gets in and out through the mask—in or out of the clinician—is through the filtered port.”

Clinicians tested out designs after working long shifts, and Vakil said some even wore them while working out. They provided feedback on designs via email and Slack. “It was a remarkably efficient iteration process, as we used 3D printed versions of the adapters to tweak the design to their satisfaction,” he said. (To hear more about how clinicians participated in the iteration process, listen to our podcast.)

Development unfolded at amazing speeds, which Campbell compared to doing “software sprints in a matter of hours rather than weeks.” Vakil agreed, also comparing development to the “rapid iteration” commonly seen in software.

Not knowing any of the obstacles and barriers a traditional medical device company might face was to the team’s benefit, Speer said, “because they didn’t let them get in their way and then they knew when to bring in people like Devon, Ken, and myself to help make sure everything was on the straight and narrow and on the right path. . . “

After settling on a design, the team turned assembly work over to Lightspeed Manufacturing, which specialized in rebuilding computers for the aviation industry. Interestingly, a member of Lightspeed’s team used to be the supply manager at Dartmouth Hitchcock Hospital and was familiar with hospital supply needs, so he “put himself right in the middle of the manufacturing line and ended up doing the quality check for every mask before it went out because it was important to him to get it right,” Vakil said.

Despite being a newcomer to medical device assembly, Lightspeed proved to be a valuable partner. “The most important decision an emerging company can make or break a company in the long run is picking a great manufacturing partner,” said Campbell.

Another amazing feat is that the team funded their work entirely through donations and in turn has been donating face shields to clinicians who don’t have access to PPE. As of October 27, has donated more than 33,000 face shields providing more than 2.3 million clinician-days of protection for those who don’t have access to PPE.

Donations to have slowed, however, as PPE shortages haven’t been making headlines as much as they did earlier in the pandemic. “But the need is still there,” said Campbell. He says the team is now focused on answering this question: “How can we continue our mission of protecting clinicians even in an environment where we’re not necessarily getting the funding that we were getting toward the beginning of the pandemic to be able to keep meeting that need. One of the ideas we’ve been exploring is [whether] there a manufacturer out there that has the bandwidth, has the capacity, is already involved in this value chain somewhere that could take it over . . . and continue forward with an engaged partner.” (Listen to the podcast for insights on how the team has readied for such a transition.)

For more insights from the team and to hear Dr. Stone's perspective, please attend the November 4 BIOMEDigital session, Heroes of Manufacturing - Boston Non-Profit Aids in Fight Against COVID-19 with Unique Reusable Face Shield, and check out the MD+DI podcast for lessons learned from the team. Dr. Boehme also explains the orgin of the idea in this video

Medtronic Acquires 7th Company in 2020

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Medtronic acquired Ai Biomed a little more than a month after its last tuck-in deal was announced. This makes the seventh acquisition the Dublin-based company has announced in 2020.

The deal gives Medtronic access to the PTeye system, a probe-based technology designed to help confirm parathyroid tissue identified visually by the physician during thyroid surgery. Before the PTeye system, surgeons relied solely on visual identification of parathyroid glands. Parathyroid glands are normally about the size of a grain of rice and found near the thyroid gland. Locating and distinguishing the parathyroid tissue from other tissue during surgery can be challenging, even for expert surgeons. The PTeye system uses dye-free technology to detect autofluorescence of parathyroid tissue in real-time in the surgical suite. The system uses a console display and disposable probe. 

In addition, Medtronic said FDA just cleared the NIM Vital nerve monitoring system, which enables physicians to identify, confirm, and monitor nerve function to help reduce the risk of nerve damage during head and neck surgery.

Medtronic said PTeye and NIM Vital are separate but complementary technologies. The NIM Vital system to help protect crucial nerves and the PTeye system to help confirm parathyroid tissue identified visually by the surgeon are complementary technologies that could be used together and enable Medtronic to address two of the most common challenges during head and neck surgery.

“The addition of these two technologies builds on our 20-year legacy of providing innovative solutions that assist surgeons during critical head and neck procedures," said Vince Racano, vice president and general manager of the ENT business, which is part of the Restorative Therapies Group at Medtronic. "By offering these complementary technologies – the NIM Vital system to protect crucial nerves and the PTeye system to help confirm parathyroid tissue identified visually by the surgeon – we're helping physicians address two of the most common challenges during these procedures."

Medtronic is coming close to topping the number of deals Boston Scientific announced in 2018. (Editor’s note: Boston Scientific announced 10 acquisitions in 2018.) However, the medtech giant differs from Boston Scientific because Medtronic is focused on smaller tuck-in deals. Recall, Marlborough, MA-based Boston Scientific paid about $4 billion to acquire BTG in 2018.

Medtronic has had a busy 2020 – frequently making medtech headlines. Whether it’s the company’s sacral neuromodulation patent spat with Axonics or the recent FDA approval of its venous self-expanding stent system, the device maker has seen a furious flurry of activity this year.



10 Things to Do During BIOMEDigital

Image courtesy of Bertold Werkmann/Adobe Stock image_Bertold_Werkmann_web.jpg

Held November 4 and 5, BIOMEDigital offers medtech professionals a wide range of educational sessions, exhibitions, and networking activities to stay connected in the industry. Click here for your free pass to the virtual event.

MD+DI shares a few must-attend activities below. All times listed are in the Eastern time zone.


Be Inspired by Keynotes and Heroes of Manufacturing

Hear from medtech leaders and innovators on today's trends as well as innovative solutions for responding to COVID-19 pandemic needs.

Wednesday, November 4 | 11:00am - 12:00pm Track: Center Stage
Surgical Robotics 5.0: The Future of Robotics in Healthcare
Keynote Speaker: Harel Gadot  (MEDX Ventures Group)

Thursday, November 5 | 11:00am - 12:00pm Center Stage
The Wave of Digital Health: The Merge from Commercial Tech to Healthcare
Keynote Speaker: Sandra Nagale, PhD  (Boston Scientific)
Please listen to our podcast with Nagale here

Wednesday, November 4 | 2:00pm - 3:00pm Center Stage
Heroes of Manufacturing - Boston Non-Profit Aids in Fight Against Covid-19 with Unique Reusable Face Shield
Moderator: Jon Speer  (Greenlight Guru)
Panelists: Devon Campbell  (CPO/SVP R&D - myBiometry), Alex Stone, M.D.  (Brigham and Women's Hospital), Sanjay Vakil  (
Listen to our podcast with the team here.

Thursday, November 5 | 9:00am - 10:00am Conference Track: Product Development Innovation
Heroes of Rapid Product Development & Manufacturing — The Ventilator Project
Speaker: Tyler Mantel  (The Ventilator Project)

Read our article with Mantel here.

Discover Opportunities for Digital Health

Several sessions in the Digital Health Conference will offer insights on developing digital health solutions:

Wednesday, November 4 | 9:00am - 10:00am Conference Track: Digital Health
Panel: Understanding Market Opportunities & Clinical Need in the Exploding Field of Digital Health
Panelists: Jennifer Joe, MD  (Biocogniv and Boston VA Healthcare System), Meghana Karande, MD  (GoInvo), Megan Ranney, MD  (Brown-Lifespan Center for Digital Health)

Wednesday, November 4 | 1:00pm - 2:00pm Conference Track: Digital Health
Recent FDA Biocompatibility Feedback from 510k Submissions
Speaker: Thor Rollins  (Nelson Labs, LLC)

Wednesday, November 4 | 2:00pm - 3:00pm Conference Track: Digital Health
How Digital Health & Enabling Tech Advancements Are Changing the Face of Minimally Invasive Surgery
Speaker: Emir Osmanagic, PhD  (Ethicon Endosurgery, a Johnson & Johnson Company)

Wednesday, November 4 | 3:00pm - 4:00pm Conference Track: Digital Health
Panel: Implementing AI in Medical Device Development Now And Into The Future
Moderator: Grant Schaffner  (Stress Engineering Services, Inc.)
Panelists: Srihari Yamanoor  (Designably), Anthony Habayeb  (Monitaur)
Speaker: Devon Campbell  (CPO/SVP R&D - myBiometry)

And don't miss the November 5 Center Stage session, Wearables with Purpose: The Future of Healthcare, with Jeanette Numbers  (Co-Founder & Principal, Loft). MD+DI interviewed Numbers last month for her perspectives.


Consider Even More New Ideas for Robotics

Hear from researchers on how robotics could have a “profound effect on businesses throughout many industries,” particularly medtech, in the session:

Wednesday, November 4 | 3:00pm - 4:00pm Track: Center Stage
Robotics Spotlight: How Research Efforts Are Changing the Way Medtech Uses Robotics
Speakers: Russell H. Taylor, PhD  (Professor & Director, Laboratory for Computational Sensing and Robotics, Johns Hopkins Whiting School of Engineering)
Gregory S. Fischer, PhD  (Professor & Director of PracticePoint Center for Healthcare Cyber-physical Systems, Worcester Polytechnic Institute)
Greg Hager, PhD  (Mandell Bellmore Professor & Founding Director of the Malone Center for Engineering in Healthcare, Johns Hopkins University)
Hao Su, PhD  (Director, Lab of Biomechatronics and Intelligent Robots/Irwin Zahn Endowed Assistant Professor, The City College of NY)


Learn About New Solutions for Product Development

Learn about rapid design, coatings, materials, and combination product development in this Product Development track focusing on innovation. It also includes the Heroes of Rapid Product Development & Manufacturing — The Ventilator Project mentioned above.

Thursday, November 5 | 10:00am - 11:00am Conference Track: Product Development Innovation
Ask the Experts: Rapid Design & Development in Highly Regulated Environments
Moderator: Siddharth Desai  (Health Care Evolution Inc.)
Panelists: Eri Hirumi  (Microvention), Laura Jeannel  (Meridian BioGroup)

Thursday, November 5 | 1:00pm - 2:00pm Conference Track: Product Development Innovation
New Developments in Conformal Coatings for Advanced Technologies
Speaker: Dick Molin  (Specialty Coating Systems)

Thursday, November 5 | 2:00pm - 3:00pm Conference Track: Product Development Innovation
Panel: The Development & Manufacturing of Combination Products for Next-Gen Healthcare
Moderator: Anthony Listro  (Foster Delivery Science)
Panelists: Alie Jahangir, PhD  (The Janssen Pharmaceutical Companies of Johnson & Johnson), Steven Persak  (Merck)
Speaker: Adam Lambert, PhD  (Pharmatech Associates, Inc.)

Thursday, November 5 | 3:00pm - 4:00pm Conference Track: Product Development Innovation
Panel: Material Innovations Driving Innovation & Quality Manufacturing
Panelist: Asmita Khanolkar  (SMC, Ltd.)
Speakers: Tony Walder  (Lubrizol), Alexis Sauer-Budge, PhD  (Exponent)


Get Pumped about 3D Printing

Hear how 3D printing is playing a role in medical device development in this Center Stage session:

Thursday, November 5  1:00pm - 2:00pm Track: Center Stage
How Health Systems Are Managing Crisis Response and Enabling Affordable Personalized Medicine with 3D Printing
Speakers: Gaurav Manchanda  (Healthcare Director, Formlabs) and Sam Murray  (Director of Regulatory Affairs and Quality Assurance, Formlabs)

And be sure to check out the 3-D printing Tech Talks below from Protolabs and Xcentric Mold and Engineering.

Get Tech Support from Tech Talks

Attend these informative sessions from suppliers:

Wednesday, November 4 | 9:00am - 9:30am
Driving Miniaturization To The Next Level
Speaker: Aaron Johnson  (Accumold)

Wednesday, November 4 | 9:30am - 10:00am
How And When To Transition From 3D Printing To Injection Molding
Speakers: Eric Utley  (Protolabs), Gus Breiland  (Protolabs)

Wednesday, November 4 | 10:00am - 10:30am
Streamlining the 6 Phases of Force Sensor Integration
Speaker: Edward Haidar  (Tekscan, Inc)

Wednesday, November 4 | 10:30am - 11:00am
Don't Estimate…Measure! Accurate Surface Characterization When The Outcome Matters
Speaker: Frederick Fiddler  (KRÜSS USA)

Wednesday, November 4 | 1:00pm - 1:30pm
Designing Security into Your New Medical Device: Start Early or Pay the Price
Speaker: Christopher Gates  (Velentium)

Wednesday, November 4 | 1:30pm - 2:00pm
Accelerate Your Device R&D!
Speakers: Barry Schnur  (David Schnur Associates), Katie Karmelek  (Chamfr), Tom Torres  (David Schnur Associates)

Wednesday, November 4 | 2:00pm - 2:30pm
Quality Assurance for the Highest Medical Standard
Speaker: Bart Newman  (Carl Zeiss Industrial Metrology, LLC)

Wednesday, November 4 | 2:30pm - 3:00pm
Performing Multi-User Virtual Surgery Over Zoom: Enabling Device Sales Through Collaborative Surgical Training
Speaker: Sam Glassenberg  (Level Ex)

Wednesday, November 4 | 3:00pm - 3:30pm
Best Practices In Using Wearable Biometric Sensors To Prove Medical Use Cases
Speaker: Steven LeBoeuf  (Valencell)

Thursday, November 5 | 9:00am - 9:30am
Transitioning Life Science Research From The Lab To The Marketplace
Speaker: Haskell Kent  (Optikos Corporation)

Thursday, November 5 | 9:30am - 10:00am
Remarkable Speed-To-Market Success With New And Traditional Manufacturing
Speakers: Kevin Hogan  (Diversified Plastics Inc.), Aliza Alverson  (Diversified Plastics Inc.), AJ Frisell  (Diversified Plastics Inc.)

Thursday, November 5 | 10:00am - 10:30am
Strategic Use of Predicate Controls In Biocompatibility Evaluations
Speaker: Chris Parker  (Toxikon)

Thursday, November 5 | 10:30am - 11:00am
Software Quality Best Practices - A Learning Discussion
Speakers: John Compton  (Agile Search Inc.), Leticia Booth  (PathAI), Sam Surette  (CaptionHealth)

Thursday, November 5 | 1:00pm - 1:30pm
Battery System Design And Manufacturing Made Easy
Speaker: Peter F Victor  (Fedco Batteries)

Thursday, November 5 | 2:00pm - 2:30pm
3D Printing And Injection Molding: Same Team, Different Roles
Speaker: Brianna Gillett  (Xcentric Mold and Engineering)

Thursday, November 5 | 3:00pm - 3:30pm
Keeping Medical Equipment Clean And Durable: High Performance Copolymers To Address Infection Control Challenges
Speaker: Nithin Raikar  (SABIC)


Get Invigorated During Innovation Power Hours

These morning or lunchtime breaks offer the chance to listen to presentations.

Wednesday, November 4 | 12:00pm - 1:00pm
Collaborating to Optimize Microfluidic Device Design and Manufacturing
Speakers: Ron Kurz  (Canon Virginia Inc.), Patrick Erb  (Canon Virginia Inc.)

Wednesday, November 4 | 12:00pm - 1:00pm
Fluid Control Solutions Customized To Your Applications
Speakers: Tony Gaglio  (Emerson), Jim Perry  (Emerson)

Wednesday, November 4 | 12:00pm - 1:00pm
Measure Force at the Tipping Point: Sensor Miniaturization and the Future of Medtech
Speaker: Maciej "MJ" Lisiak  (FUTEK Advanced Sensor Technology)

Wednesday, November 4 | 12:00pm - 1:00pm
Quality Inspection - Digital Microscopy and Ergonomics by Leica Microsystems

Wednesday, November 4 | 1:00pm - 2:00pm
Complex Challenges Require Straightforward Solutions
Speaker: Arjun Luthra  (BioInteractions Ltd.)

Thursday, November 5 | 12:00pm - 1:00pm
Driving Complex Medical Device Design Control
Speaker: Larry Sampson  (Siemens Digital Industry Software)

Thursday, November 5 | 12:00pm - 1:00pm
Engineers Design Guide For Precision Stamped Metal Parts
Speakers: Rommel Del Sol  (Meier Tool & Engineering (A Cretex Medical company)), Jon Preston  (Meier Tool & Engineering (A Cretex Medical company))

Thursday, November 5 | 12:00pm - 1:00pm
Manufacturing Success: Five Secrets
Moderator: Andy McMillan  (Cirtronics Corporation)
Panelists: Adam Shayevitz  (Strategic Sourcing Dynamics, LLC), Steve Miller  (Convergent Dental), Tracey Wielinski  (Cytrellis Biosystems, Inc.), Larry Jasinski  (ReWalk Robotics, Inc.)

Thursday, November 5 | 12:00pm - 1:00pm
Understanding Key Reimbursement Concepts to Optimize Design Decisions
Speaker: Tom Hughes, JD  (Covance Medical Device & Diagnostics)


Tour the Interactive Expo Hall

Discover more than 90 suppliers and have public or private live chats with exhibitors about their products. You can also view products, videos, and whitepapers within each virtual booth. Click here for a list of exhibitors.


Visit the Start-up Stadium

Presented by MassMEDIC, the Start-Up Stadium will offer 5 rounds of start-up pitches. You’ll also hear from expert panels on how to get financing and launch a successful start-up.



MassMEDIC will host a zoom happy hour, offering you the chance to mingle and network in smaller zoom breakout rooms. To access the happy hour on the day, visit the BIOMEDigital Networking Lounge, and click on the “MassMEDIC Breakout Happy Hour” callout. The zoom link will be waiting for you.

We will also host a TRIVIA QUIZ, hosted by Two Bit Circus, where you can compete with colleagues and new friends to win this interactive and fun quiz! Access link can be found in the BIOMEDigital Networking Lounge. Capacity is limited so please make sure you are on time! Participate and get a chance to win a $100 Amazon gift card.

Next, be sure to join the Interactive Speed Networking session on Thursday, Nov 5th at 1:00pm EST to be matched up according to your areas of expertise/interest.

Finally, meet speakers in themed breakout rooms for “Meet the Speakers Happy Hour." To access the happy hour on the day, visit the BIOMEDigital Networking Lounge, and click on the “Meet the Speakers Happy Hour” callout. The zoom link will be waiting for you!

Foldax Presses Through COVID-19 with Trial Expansion

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It’s not easy being a start-up during the COVID-19 pandemic. There are always concerns about limited investor capital due to the stain on the economy. There’s also the issue of clinical trials being interrupted because of shutdowns in the states where the studies are located.

Despite these odds, Salt Lake City, UT-based Foldax is proving that startups can have success during the pandemic. Recently the company announced it received FDA’s blessing to expand a clinical study of the Tria surgical aortic valve.  

Ken Charhut, chairman of Foldax, said the FDA’s approval is for an additional 25 patients and would top off enrollment capacity at 40. The next stage of enrollment is scheduled to be in November.

“We’re breaking new ground here and our intention all along was to get as much information about the valve’s performance in a patient population as possible,” Charhut told MD+DI on Tuesday. “We purposefully wanted to begin in the aortic valve position because it’s one of the most well-studied positions in the valve world. This gives us the confidence to move forward.”

The Tria valve reimagines the heart valve by incorporating the company’s biopolymer – LifePolymer – with a valve design intended to resist calcification, withstand stresses and strains without failure and restore the patient’s quality of life without lifelong use of anticoagulants.

Tria is robotically manufactured, and the company said this reduces variability, enables high precision, repeatability, and quality, while substantially improving the economics of heart valve manufacturing.

“We found this biopolymer that is stable and uniquely developed for the heart valve position, “ Charhut said. “And utilizing the biopolymer allowed us to utilize robotic manufacturing, which gave us an advantage for efficiencies. The polymer also allowed us to design a valve that could be close to what the native valve is like. It’s performing as we expected it to do. It’s very easy to implant – we haven’t changed the implant procedures of surgeons.”

Although Foldax is working is focused on the surgical aortic valve plans call for the company to commercialize a transcatheter aortic valve replacement device.

“We recognize the TAVR market, we recognize the significance of that, and we are actively working on that product as well,” he said.

Foldax Makes Progress

Foldax won an IDE from FDA in February of last year. It was a different time – a full-blown year before the COVID-19 crisis. Some firms have had to deal with interruptions to clinical trials. Foldax has been fortunate enough to not have been in this position. However, that doesn’t mean the firm is immune to potential issues that could arise from the pandemic.

“We were fortunate enough to have enrolled all of the patients before the shut-down occurred – back in March,” Charhut said. “But then we were affected by follow up. As the hospitals shut down, we had to do some remote follow-ups. Now that have approval to do more patients we are at the mercy -like every other company – that the centers we’re using remain open to research; their employees can show up at the hospital and patients can show up.”

Start-ups have also had to be creative when it comes to securing venture capital. Augmedics, a firm that has developed an augmented reality surgical image guidance technology, had to form a limited liability company to raise $4 million to close its $15 million series B round.  

Foldax was able to secure $20 million in a series D round in June. MemorialCare Innovation Fund (MCIF) led the round, with Angel Physicians Fund (APF) and Sayan Bioventures joining as new investors. All existing investors also participated in the round, including BioStar Capital, Kairos Ventures, and Caltech. Brant Heise, MCIF Managing Director, joined the board in conjunction with the investment.

“Getting financing is never a layup,” Charhut said. “But this one had an enthusiastic investor base. We were able to close it right in the middle of COVID with not even personally having to meet some of the investors. We feel fortunate for that and I think it speaks to the technology and the promise of what it can be. People get it …”


Let’s Talk Medtech

Introducing 'Let's Talk Medtech'

This week MD+DI is launching a new podcast, Let's Talk Medtech.

Our goal with this podcast is to share our perspectives as well as talking with the newsmakers and thought leaders in the medtech industry. We have an exciting lineup of guest speakers that we are looking forward to hosting on Let's Talk Medtech. In this pilot episode, MD+DI's editorial team discusses trends we have been following in the medical device and diagnostics industry, and developments to watch for in the coming months.

So without further ado, here is Let's Talk Medtech:


The Circular Healthcare Economy: Suppliers, Lawmakers—Time’s Up

Image courtesy of Innovative Health 1435-North-Hayden-Rd-Lab-2-Photo-3_Ad_web.jpg

The pandemic has made (at least) three things clear to healthcare supply chain leaders:

  1. We have to build resiliency into the supply chain.
  2. We have to find a way of reducing device costs.
  3. We need to learn how to re-use devices.

These are enormous tasks hardly achieved with short-term stop-gaps such as Emergency Use Authorizations and the C.A.R.E.S. act. However, one approach comes close to effectively addressing all three: a circular healthcare economy. This is more than a lofty vision; circular economy principles are being built into European legislation, and there are plenty of examples of how it can work in reality. However, while healthcare administrators are ready to rethink a single-use healthcare culture, suppliers and legislators are slower to act.


Resiliency, Costs, and Device Re-Use

Politicians and healthcare leaders alike have pointed to the painful lesson from the pandemic that we are simply too dependent on fragile, international supply relations. In the pandemic, we’ve seen the emergence of emergency supply solutions where product quality is unpredictable, supply quantities are determined by who-comes-first, and pricing completely lacks transparency. A domestic supply chain would insure us against these problems. There is a need to bring production of devices such as face masks and gloves back to the United States, so that supplies can be controlled in times of crisis and certainty about device availability can be established.

Net operating income for many U.S. hospitals was a complete disaster in the second quarter of 2020. Profitable elective procedures were shut down, and more expensive hospital activities demanded more resources. A double-hit. While the situation is unprecedented and it is understandable that it was not planned for, hospital margins are already razor thin and can be managed really only with two levers: labor costs and supply costs. Most hospitals are stretched thin in terms of labor, which leaves managing the margin by controlling supply costs the one tool in the hospital administrator’s hand. On the medical device side, technology innovation and the constant launch of more advanced devices keep driving the cost up.

This is an unsustainable state of affairs for hospitals. We need a “new deal” for hospitals to remain financially viable.

In March, hospital staff suddenly found themselves meeting for hours to sew make-shift face masks. They established face mask re-use programs and otherwise tried to get one more use out of single-use devices. These activities ran directly counter to the deep-seeded mindset in healthcare to use things once, then replace them with new items, because of infection risks. In other words, the mantra has been, "The more we throw away, the safer we are." 

However, the pandemic fundamentally compromised this single-use mindset—particularly when healthcare workers started digging in the garbage to find yesterday’s face masks so they at least had something to protect them. What emerged from this situation was a new awareness that we need to move away from our current single-use culture.


Circular Healthcare Economy Barriers

Last month, Moody’s published its For-Profit Hospital Forecast. The forecast credits hospitals for their response to the pandemic, noting that some hospitals were able to reduce costs significantly while revenue sank. However, these cost savings are not sustainable in the long run, and hospitals are faced with the challenge of creating systemic changes in their supply chain. For now, hospitals face a tough Q3 and Q4 with the pandemic still lingering and C.A.R.E.S. Act money running out. Without the boost from this, for-profit hospitals would have seen a 37.5 percent EBITDA decline in Q2.

A week later, Supply & Demand Chain Executive published an article about the promises of a circular economy approach to supply chain management. These include the opportunity to drive down costs while also reducing supply risk. Essentially, a circular economy approach addresses multiple challenges at the same time.

A circular economy, in terms of medical devices, means that instead of looking at device utilization as a linear production-consumption process, you look at the “consumed” product as the raw material for another consumption: The production-consumption process becomes circular. End-of-life is extended, device-cost-per-use goes down, and you establish more control of the supply chain. And don’t forget: The device does not end up in the landfill after only one use. The circular economy is the confluence of financial, clinical, and environmental supply chain drivers.

Let’s be fair: Hospitals do re-use devices. The hospital’s central sterile department captures and sterilizes many devices every day. These are devices that are designed to be re-used, and the manufacturer publishes guidelines for how to clean them and for how many times they can be re-used. However, manufacturers increasingly turn yesterday’s reusable devices into tomorrow’s single-use devices.

In the 1990s, hospitals were reprocessing everything from endoscopes to cardiac ablation catheters. In the early 2000s, manufacturers lobbied FDA to outlaw this practice. Since then, catheters that used to be “re-usable” suddenly emerged as “single-use.” Of late, even re-usable cables connecting instruments with capital equipment (and not touching the patient) have been “re-invented” as single use. As a result, the most expensive devices used in hospitals have a “single-use” label on them, while less expensive devices can be re-used according to the manufacturer’s instructions for use.

This is, of course, because the greatest threat to a device manufacturer’s profitability is the re-use of its product. When a device is re-used, you lose a sale. Similarly, the concept of a circular healthcare economy is antithetical to the manufacturer’s profit model. However, we have seen how this model can prove dangerous, not just to hospitals’ financial situation, but to the safety of both healthcare workers and patients.


Single-Use Device Reprocessing as a Circular Economy Solution

The challenge for a circular economy model in healthcare, according to the Supply & Demand Chain Executive article, is that the suppliers lose ownership of the product with the sale and don’t have access to the product at end-of-life; it is difficult to effectively collect the used product, and most used products have low residual value. That said, refurbishing generally provides more value than recycling, both environmentally and financially.

There is an existing practice used in healthcare that represents a circular economy in action and can provide a broader model for the path forward: single-use device reprocessing. The practice became common in the 1990s with hospitals re-sterilizing single-use devices. This in-house practice was outlawed in the early 2000s and replaced with a practice in which advanced single-use device reprocessing companies make the devices ready for another use. The practice is tightly controlled by FDA in a process that requires the reprocessor to obtain FDA clearance for devices they reprocess. This clearance is similar to the clearance original manufacturers need to obtain to sell the new device. An FDA clearance to reprocess a device means the reprocessed device is substantially equivalent to the new device and presents no added risk to the patient.

In single-use device reprocessing, the used product becomes the raw material for a reprocessed product. Reprocessors collect the devices after use at the hospital; send them to the reprocessing plant; clean, inspect, test, and sterilize the devices; and sell them back to the hospital at a much lower price than the new device. The production-consumption process has become circular, reducing procedure costs, supply chain dependency, and environmental impact.

Moreover, single-use device reprocessing has broken all the barriers identified in the Supply & Demand Chain Executive article: Devices are efficiently collected at the point of care after use from hospital staff that is eager to make the used devices available, and the ownership transfers to the reprocessor. The industry is increasingly focusing on devices with a relatively high residual value, so the economic impact to hospitals is increasingly substantial. Some hospitals save well over a million dollars a year using single-use device reprocessing.

I submit that single-use device reprocessing should become a circular economy model for the future of healthcare. This means:

  1. Hospitals should work with reprocessors and other circular economy industries to identify areas where the hospital can transition from single-use practices to re-use practices that are safe and efficient.
  2. Hospital staff should promote and utilize circular economy practices like reprocessing, not just to reduce hospital costs, but to ensure sustainable supply chains and reduce overall financial and patient care vulnerability.
  3. Suppliers should focus on developing products that are designed for re-use and work with reprocessors to leverage advanced reprocessing technologies so that the lifecycle of their products can be extended.


A Call to Medical Device Suppliers and Lawmakers

In a September Letter from the Editor, Bradley P. Knight, MD, FACC, FHRS, Editor-in-Chief of EP Lab Digest wrote that “[a]ny technology or technique that is better, safer, or faster will only be adopted if it is at least cost neutral. More efforts are needed to develop strategies that require fewer catheters and take advantage of reprocessing.” Hospital staff understands the relationship between re-use and supply chain resiliency, cost reduction, and the environment. Supply chain professionals are endorsing it. Increasingly, clinical staff is embracing it.

The time for suppliers to also be a part of the solution is now. Time is up for the single-use design paradigm. It is inadequate from an environmental, financial, supply chain, and, ultimately, patient care perspective. Healthcare needs manufacturers that are thinking in terms of healthcare resiliency and sustainability, not just in terms of profitability.

Single-use device reprocessing, particularly as a collaboration between reprocessor and manufacturer, is a great short-term solution. However, in the longer term, device manufacturers ought to work on designing devices that can be re-used, perhaps under a new legal paradigm.

From a legislative perspective, we need to focus on the notion of a “reprocessable device,” developed in collaboration among hospitals, manufacturers, and reprocessors. A reprocessable device label would indicate a device that can be re-used, but only to a limited extent (most high-value reprocessable devices can only be reused 1-3 times), and only by highly regulated reprocessors. This would enable manufacturers to become part of the solution and live up to their responsibilities as integrated players in a hospital supply chain that is struggling to economically deliver the right care to as many patients as possible.

The reprocessing industry is standing by with advanced reprocessing technologies to clean, inspect, and validate the reprocessing and reuse of even very complex devices.