Pandemic Pressures and Ripple Effects on Medical Device Materials

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Navigating the stringent and ever-changing regulatory requirements of the FDA is far from a new balancing act that medical device manufacturers face on a daily basis. But the many pressures arising from the pandemic, such as supply chain disruption coupled with a strict regulatory environment, have intensely amplified the challenges facing medical device engineers, severely affecting speed to market, cost and availability of devices.

Among the many ripple effects, access to raw materials is an important ramification forcing engineers to search for alternative materials that continue to provide effective and safe patient care.

Jacqueline Anim, Principal Materials Engineer at Ethicon Endo-Surgery, prepares to meet these challenges and opportunities in the upcoming Design. Engineer. Build a 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.

As the event approached, I spoke with Anim about his upcoming session and the trends attendees can expect to learn more about.

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

Animation : The medical industry fell into the essential category; therefore, no limitations were imposed on this group. However, supply was limited due to inventory depletion and other delays, such as holding large amounts of in-process inventory just to wait for a single piece to arrive before being able to ship the final product. .

And the pandemic has coincided with the most disruptive impact on the resin industry, and it’s hard to separate the two while it persists. Ice storms in Texas and the southeastern United States limited access to ethylene monomer, glass, silicone, and adipic acid, among others, impacting the supply chain and the availability of many medical grade resins. The suppliers that had the leverage were those that were vertically integrated into the supply chain.

I will, on the other hand, digress to say that the impact depended on where you were in the value chain and the application since, during the pandemic, many new R&D projects have been suspended to take out the PPE in order to relieve the situation. and produce incubators, masks and ventilators. Subsequently, and after this situation was mitigated, the goal was to keep the ship afloat rather than launch a new project until the end of 2021. But in 2022, most organizations launched new project development activities.

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

Animation : The multiplicity of my view may include but not limited to GM and other non-medical companies starting to manufacture ventilators which triggered large orders instead of small companies buying PP, PE, TPE for masks, tubes and connectors. According to RTP’s Bob Williams, a positive trend is that it has paved the way for constant communication with engineers and OEMs to regulate and track large orders related to COVID.

Engineers had to focus on alternative materials to mitigate supply chain disruptions. Example: If critical parts, such as sensors, were not available, engineers had to look for alternative materials for validation, such as replacing a ceramic/copper alloy part with aluminum.

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

Animation : My message to the industry is to focus on specialty compounds, materials with opacity additives, the use of reinforced plastics and many precision plastics with coatings for dimensional stability and weight reduction. Also, converted metal-plastic designs for surgical robotic instruments or a combination of metal-plastic hybrids for weight reduction and cost savings.

An important development to note is the post-COVID trend towards robotic surgery, which requires space-constrained materials or thin walls, high loading, and higher performance plastics. In this new space, engineers may not have an infinitesimal amount of time and capacity to test to failure, so they will likely lean on the safer side by overspecifying and selecting high-end materials. , for example, PEEK, PEK, PBI, PAI and APP. However, with more experience the industry will learn and decide if this is overkill and adjust the material selection criteria.

It almost feels like the flood door is wide open for wearables, bedside devices, and accessories. And with more emphasis on sterilization i.e. UV radiation or multipurpose EtO, materials such as PEEK with carbon fiber filler are preferred as they minimize the price of the PEEK and other materials from the ketone family.

This reminds me of Dan Price’s post about supply chain disruption and the innovation that could come from it around circular economy principles in medical devices. According to Ethicon member Dan, customers in Europe have always trusted the design of multi-purpose devices, especially devices with internal motors, built-in transducers, circuit boards, motors, etc., to be recovered and reused, thus using more high-value components and less dependence on new raw materials. Given the current situation, circular economy principles will move to other parts of the world and be applied to medical devices due to the pandemic and other factors; the combination of supply chain destructions and the circular economy principle is likely to provide some cushioning. The circular economy can be the solution for the sustainability of medical devices and device material supply.

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

Animation : Attendees should expect to learn more about the medical market trend regarding the direction of product design. Additionally, they will hear about supply chain disruptions, their influence on medical materials and patient care, and the ripple effects of supply disruption on medical device design and manufacturing. .

I look forward to exploring the challenges the industry is facing and sharing insights on the matter and discussing general trends with respect to value chain pressures and influences. Ultimately, you will have the chance to gain insight into the latest developments to improve future medical device design and patient care.

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

Animation : It’s an internal feeling that there’s flexibility to move around the office carefully and attend conferences like Design. Engineer. Build., as for some time the in-person industry connection was suspended. I join my many colleagues in expressing my desire to meet face to face.

I remember a conversation with my project partner Heather Crafton from DePuy, who said she was ready to go back and hit the trade show floors touching and smelling new samples and networking with suppliers. Connecting in person and touching and feeling the innovation gives you a better understanding than in a virtual environment.

To listen to Jacqueline Anim’s session at MD&M West, Recent trends in balancing regulatory and supply chain pressures with design flexibility for medical device materials April 12 at 4:30 p.m., register for the event here.

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