Navigating FDA’s strict and ever-changing regulatory requirements is far from a new balancing act that medical device manufacturers face daily. But the many pressures born from the pandemic, such as supply chain disruption coupled with the stringent regulatory environment, have intensely magnified the challenges medical device engineers face, severely impacting device speed-to-market, cost, and availability.
Of the many ripple effects, access to raw materials is a significant ramification forcing engineers to seek alternative materials that continue to deliver effective and safe patient care.
Senior principal materials engineer at Ethicon Endo-Surgery, JACQUELINE ANIM is gearing up to address these challenges and opportunities at the upcoming Design. Engineer. Build conference to be held at MD&M West April 12-14, 2022, at the Anaheim Convention Center. Rob Klein, senior materials engineer, ArtiCure, will join Anim on stage. With the event around the corner, Adrienne Zepeda, Group Event Director, MD&M West spoke with Anim about her upcoming session and the trends attendees can look forward to learning more about.
MD&M WEST : How did the pandemic impact the medical device industry?
JACQUELINE ANIM: The medical industry was part of the essential category; therefore, no limitation was placed on this group. However, supply was tight due to inventory depletion and other delays, such as holding large quantities of in-process inventory just to wait for a single part to arrive before you can ship the final product became normal.
And the pandemic coincided with the most disruptive impact on the resin industry, and it’s difficult to decouple the two as it lingers. The ice storms in Texas and the Southeast U.S. have limited access to ethylene monomer, glass, silicone, and adipic acid, among others, thus impacting the supply chain and availability of many medical-grade resins. The suppliers that had the leverage were those vertically integrated with the supply chain.
I will, on the other hand, stray to say that the impact was dependent upon where you are in the value chain and application since, during the pandemic, many new R&D projects were put on hold to get PPE out to de-bottleneck the situation and produce incubators, mask, and ventilators. Subsequently, and after that situation was mitigated, the focus was to keep the ship afloat rather than launch a new project through the end of 2021. But in 2022, most organizations have kick-started new project development activities.
MD & MW: Any positives/innovations that resulted from the initial onset of challenges?
JA: The multiplicity of my perspective may include but is not limited to GM and other non-medical companies that are starting to manufacture ventilators, which triggered large orders instead of small companies that bought PP, PE, TPE for masks, tubing, and connectors. According to Bob Williams of RTP, one positive trend is that it opened the gateway for constant communication with engineers and OEMs to regulate and track large COVID-related orders.
Engineers had to flex their focus toward alternative materials to mitigate supply chain disturbances. Case in point: if critical parts, such as sensors, were not available, engineers had to investigate alternate materials for validation, such as substituting a ceramic/copper alloy part with aluminum.
MD & MW: Any new medical device material trends we should keep an eye out for?
JA: My message to the industry is to focus on specialty compounds, materials with opacity additives, reliance on reinforced plastics, and lots of precision plastics with coatings for dimensional stability and weight reduction. Also, metal-to-plastic converted designs for surgical robotic instruments or a combination of metal and plastic hybrids for weight reduction and savings.
A significant development to note is the post-COVID trend toward robotic surgery, which requires space-constricting materials or thin walls, a high load, and more high-performance plastics. In this new space, engineers may not have infinitesimal time and capability to test to failure, so they most likely will lean on the safest side by over-specifying and selecting high-end materials, e.g., PEEK, PEK, PBI, PAI, and PPA. However, with more experience, the industry will learn and decide if it’s an overkill and adjust the material selection criteria.
It almost looks like the flood gate is wide open for handheld devices, bedside devices, and accessories. And with greater emphasis on sterilization, i.e., UV radiation or EtO for multiple uses, materials such as PEEK with carbon fiber loading are preferred as they minimize the price of PEEK and other materials in the ketone family.
I am reminded of Dan Price’s message around supply-chain disruption and the innovation that could spur out of it around circular economy principles in medical devices. According to Dan, a fellow at Ethicon, customers in Europe have always trusted design around multiple-use devices, especially devices with internal motors, integrated transducers, circuit board, engines, etc., to be reclaimed and reused, thus using more of the high-value components and less reliance of new feedstock. Looking at the current situation, circular economy principles will trend toward other parts of the world and be applied to medical devices due to the pandemic and other factors; the combination of the supply chain destructions and the circular economy principle are likely to provide cushioning. The circular economy may be the solution for medical devices and device material supply sustainability.
MD & MW: I understand you’re speaking at MD&M West. What can attendees look forward to learning in your session?
JA: Attendees should expect to learn about the medical market trend concerning product design direction. Also, they’ll hear about the supply-chain disturbances, their influence on medical materials and patient care, and the trickle-down effects of supply interruption on medical device design and manufacturing.
I’m looking forward to exploring the challenges the industry is facing and sharing perspectives on the issue and discussing the general trends with regard to pressures and influences on the value chain. Ultimately, you’ll have the chance to garner insight into the latest developments to enhance future medical device design and patient care.
MD & MW: What excites you most about reuniting with your community in person?
JA: It’s an internal feeling that there’s flexibility to move carefully relative to and from the office and attend conferences like Design. Engineer. Build., since for a while, in-person industry connection was on hold. I join my many colleagues in expressing my desire to reunite face-to-face.
I recall a conversation with my project partner Heather Crafton from DePuy, who said she’s ready to go back and walk the floors at the trade shows touching and feeling new samples and networking with the suppliers. To connect in-person and touch and feel innovation gives you a better understanding than in a virtual environment.
