Moving parts of medical device production

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 are also catalysing new and innovative solutions to emerge and improve the delivery of patient care.

As the pandemic has consumed every corner 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 suppliers, the medical community has come together to meet the endless need for healthcare products, even amid unprecedented supply chain challenges.

We are seeing societal changes in healthcare delivery, such as remote and digital healthcare, reconfiguring the way treatment is delivered to each patient. This is a challenging but historic time for healthcare and medical device manufacturing.

Spearheading the advancement of medical technology is Rob Klein, Chief Materials Engineer at AtriCure Inc., with whom I had the pleasure of speaking.

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

What impact has the pandemic had on the medical device industry?

Klein: I speak from my perspective as a materials engineer in 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 become physically and emotionally ill from the pandemic, and it has really re-emphasized the importance of health care for our society. This is for people in need of treatment for pandemic-related issues, as well as those who have a harder time getting treatment for other issues during the challenges of the pandemic. We have seen the importance of this at AtriCure, where “elective” procedures have sometimes been delayed during the pandemic.

Also, like everyone else, there has been a colossal shift in the way medical device companies do business. More flexible work structures, more emphasis on personal health, more online collaborations, more emphasis on work product, and less emphasis on physical presence.

And finally, the pandemic, combined with other natural and man-made disasters, has resulted in the worst supply chain issues in a generation. It took a lot of effort from other businesses to keep production going in the face of this. There have been more force majeure, award and obsolescence notices from vendors in the last two years than likely in the previous ten years combined.

Are there any positives/innovations that resulted from the initial appearance of the challenges?

Klein: First, I would like to pay tribute to all those on the front lines — nurses, doctors, hospital staff — who have shown extraordinary courage in the face of so many pandemic challenges. Second, I would like to thank those who have researched, developed, and manufactured protective clothing, ventilators, COVID vaccines, COVID treatments, and related delivery devices and packaging. It was absolutely amazing to see how quickly these activities scaled up and were largely successful. All of these people are an integral part of the health care community.

Third, I think the healthcare industry as a whole has responded very positively in terms of maintaining innovation and production while dealing with huge changes in work environments, the supply chain. procurement and regulatory requirements. In my personal experience, AtriCure has maintained production (and growth) 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 to focus on high quality medical products to save lives.

How have tariffs and the changing regulatory landscape impacted the materials used in the design of medical devices?

Klein: In terms of the regulatory landscape, the most impactful from my point of view is the entry into force of the EU MDR regulation. In addition, emphasis has been placed in recent years on the conformity of materials. This includes new regulations as well as a growing list of controlled substances. Mainly for EU, but also worldwide – USA, UK, Japan, China, Canada, Brazil, Australia etc. – there is also increasing emphasis on biocompatibility controls.

All of this added new challenges to my work as a materials engineer. Yet, I believe it has also generated a new urgency to assess and minimize material risks – and this urgency benefits user and patient safety. For example, regulators have recently established stricter restrictions on, for example, phthalates, bisphenol A and perfluorinated substances. This increases the effort and cost involved in developing medical products, but it can, in my opinion, be valuable.

How have manufacturers pivoted/innovated accordingly?

Klein: Since the bar has been raised for safety and compliance information with these new and updated regulations, a lot of time and effort is required for V&V and documentation. These regulations have a daily impact on companies like AtriCure and all of our suppliers. In addition, we are carrying out a much more in-depth review of our supply chain in order to increase its robustness in the face of potential shortages and obsolescence.

Of course, our suppliers have also been affected by supply chain issues and increased requirements, and we are all working on these issues together.

Are there any new medical device trends we should watch out for?

Klein: Sustainability in the medical device industry has lagged a little behind other industries as it is very difficult to change medical devices due to regulatory requirements. We attach great importance to safety. But the importance of sustainability in design and sourcing becomes a bigger factor. It’s an extremely difficult balance between sustainability and safety/stability, and I think we’ll see more effort, especially around sustainable packaging, in the years to come.

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

I understand you’re talking to MD&M West. What can participants expect to learn in your session?

Klein: My co-speaker Jackie Anim and I will go over many of these same talking points mentioned above. We’ll talk about supply chain and regulatory challenges over the past two years and some of our strategies to mitigate their impact on our businesses. It has been quite an experience taking on these crazy challenges and looking for ways to make our supply chain more robust. There was quite a bit of collaboration between product development, manufacturing, quality, regulatory, and supply to make it all work.

What excites you the most about reuniting with your community in person?

Klein: It will be amazing to see everyone in person again!! It’s been two very long years since we’ve had a major in-person medical plastics meeting. There is palpable excitement from the community, with many great speakers and meetings planned. I expect MiniTec and MD&M West to be well attended this year.

I look forward to sharing stories about the pandemic with my colleagues in person and talking about moving beyond the pandemic.

To follow Rob’s session, sign up for MD&M West here and log into the event’s online platform to access additional educational content.

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