As materials engineers manage several new challenges, there is a new urgency to evaluate medical device materials and minimize risks, opines ROB KLEIN. Adrienne Zepeda reports.

The challenges facing the healthcare industry are constantly changing. Such intense disruption makes challenges, such as the limited production and supply of medical devices resulting from supply chain chaos, more acute. But, from a glass-half-full perspective, they also catalyze new and innovative solutions to emerge and improve the delivery of patient care.

While the pandemic consumed all corners of the healthcare industry’s time over the past two years, the new solutions and cross-industry collaboration are truly remarkable. From medical device manufacturers to providers, the medical community came together to tackle the never-ending need for healthcare products, even amidst unprecedented supply chain woes.

We see societal shifts in healthcare delivery, such as remote and digitally-enabled healthcare, reconfiguring how treatment is distributed to each patient. It’s a challenging but historic time in healthcare and medical device manufacturing.

Spearheading medtech advancement is Rob Klein, lead materials engineer at AtriCure Inc., who I had the distinct pleasure of speaking with.

In a recent conversation, we explored the current state of the medical device manufacturing industry, touching upon his session at MD&M West, a three-day expo and conference held from April 12-14 at the Anaheim Convention Center. Klein will take the stage at the Design. Engineer. Build Conference on Tuesday, April 12, addressing “Recent Trends in Balancing Regulatory and Supply Chain Pressures with Design Flexibility for Medical Device Materials.”

MD&M WEST : How did the pandemic impact the medical device industry?

ROB KLEIN: I’m speaking from my perspective as a materials engineer at a medical device company and not as an official representative of AtriCure.

First and foremost, we have seen the immense tragedy of people all around us who have gotten physically sick and emotionally sick from the pandemic, and it has really re-emphasized the importance of healthcare for our society. This is for people needing treatment for pandemic-related issues, as well as those who find it harder to get treatment for other issues during the challenges of the pandemic. We have seen the importance of that at AtriCure, where “elective” procedures were being delayed at times during the pandemic.

Also, similar to everyone else, there has been a colossal shift in how medical device companies conduct business. More flexible work structures, more emphasis on personal health, more online collaborations, more emphasis on work product, and less focus on being physically present.

And finally, the pandemic, combined with other natural and man-made disasters, has led to the worst supply chain problems in a generation. It has taken a lot of effort away from other activities to keep production going in the face of this. There have been more force majeure, allocation, and obsoletion notices from suppliers in the last two years than probably in the previous ten years combined.

Any positives/innovations that resulted from the initial onset of challenges?

RK: First, I would like to recognize all those on the front lines—nurses, doctors, hospital staff—who showed extraordinary courage in the face of so many pandemic challenges. Second, I’d like to recognize those who researched, developed, and manufactured protective garments, respirators, COVID vaccines, COVID treatments, and related delivery devices and packaging. It was absolutely amazing to see how quickly these activities ramped up and were largely successful. All of these people are a huge part of the healthcare community.

Third, I think the healthcare industry as a whole has responded very positively in terms of keeping innovation and production going while dealing with huge changes to work environments, supply chain, and regulatory requirements. From my personal experience, AtriCure has kept production going (and growing) through creative manufacturing controls while also focusing on new product development. Creativity in the face of these unprecedented challenges has helped keep us engaged and excited and allowed us to continue our focus on high-quality medical products to save lives.

MD&M W: How have tariffs and the changing regulatory landscape impacted materials used in medical device design?

RK: In terms of the regulatory landscape, the most impactful from my perspective is the EU MDR regulation going into effect. In addition, there has been heightened focus in recent years on material compliance. This includes new regulations as well as an increasingly long list of restricted substances. Especially for the EU, but also worldwide—US, UK, Japan, China, Canada, Brazil, Australia, etc.—there is also a growing emphasis on biocompatibility controls.

All of this has added new challenges to my work as a materials engineer. Still, I think it has also generated a new urgency to evaluate and minimize materials hazards—and this urgency benefits user and patient safety. For example, regulatory agencies have recently established tighter restrictions on, for example, phthalates, bisphenol A, and perfluorinated substances. This increases the effort and cost involved in medical product development, but this can in my opinion be valuable.

MD&M W : How have manufacturers pivoted/innovated as a result?

RK: Since the bar has been raised for safety and compliance information through these new and updated regulations, significant time and effort are needed for V&V and documentation. These regulations impact companies like AtriCure on a day-to-day basis and all of our suppliers. In addition, we are performing a much more extensive review of our supply chain in order to increase robustness in the face of potential shortages and obsolescences.

Our suppliers have, of course, also been hit by supply chain issues and heightened requirements, and we are all working through these issues together.

MD&M W : Any new medical device material trends we should keep an eye out for?

RK: Sustainability in the medical device industry has lagged a bit behind other industries because it is very difficult to change medical devices due to regulatory requirements. We have a strong focus on safety. But the importance of sustainability in design and sourcing is becoming a larger factor. It is an extremely tough balance between sustainability and safety/stability, and I think we’ll see more efforts, especially around sustainable packaging, in the coming years.

There is also a high level of innovation in the medical device industry around new tools and procedures that enable less-invasive and faster-recovery surgeries. The next few years will be very exciting as AtriCure and other companies continue this process—there are a lot of fascinating products in the pipeline.

MD&M W : I understand you’re speaking at MD&M West. What can attendees look forward to learning in your session?

RK: My co-speaker Jackie Anim and I will review many of these same talking points mentioned above. We will talk about supply chain and regulatory challenges during the past two years and some of our strategies to mitigate their impact on our companies. It has been quite an experience to live through these crazy challenges and to look for ways to make our supply chain more robust—there has been quite a significant collaboration between product development, manufacturing, quality, regulatory, and procurement to make it all work.

MD&M W : What excites you most about reuniting with your community in person? 

RK: It will be amazing to see everyone in person again!! It has been a very long two years since we have had a large medical plastics meeting in person. There is a palpable excitement from the community, with many excellent speakers and meetings planned. I expect that the MiniTec and MD&M West will be well attended this year.

I am looking forward to exchanging pandemic stories with my colleagues in person and talking about moving beyond the pandemic.