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NAMSA Moderator Interview, E&L USA 2024

Ahead of Extractables and Leachables USA 2024, producer Ashli Speed spoke with program moderator Sheri Krajewski, Senior Global Product Marketing Manager, Biological Evaluation of Medical Devices at NAMSA, to discuss the upcoming event. Sheri is moderating panel Speaker Roundtable: Perspectives on E&L Experiences with Chemical Characterization, featuring Boston Scientific, Cook Research Incorporated, and Baxter International.

Why have you decided to participate in Smithers E&L USA 2024? Tell us about your involvement in the conference. 

NAMSA is happy to sponsor as well as work to bring a medical device focused panel to this conference. The presence of thought leaders exchanging information in an open forum is always attractive to us as we work to help medical device manufacturers with their regulatory challenges, many of which revolve around Extractables testing.

The panel you put together is titled " Perspectives on E&L Experiences With Chemical Characterization” can you tell us why you felt this topic should be shared with the Smithers E&L audience?

As the medical device industry continues to face many regulator challenges with chemical characterization, we are always looking for ways to bring manufacturers together and share experiences to learn from one another. We felt this conference was a perfect place to add this topic and experience.

What do you hope delegates will take from your presentation? 

If nothing else, the goal is to help others see that challenges are occurring with all types of devices, and that many have overcome these challenges with unique evaluation strategies and testing strategies. We learn from one another as we share real world experiences.

What industry barriers/challenges exist, technical or otherwise, that prevent progress? 

We have had a number of very important standards updated as well as new challenges with the advances in chemical analysis of medical device extractables and the toxicological risk assessment and of course the introduction and subsequent extension of the MDR. As we work through daily experiences with both regulators and sponsors, we are seeing struggles with getting new devices cleared as well as addressing changes to already marketed devices, potentially delaying innovative solutions. Being closely involved with not only a laboratory but with a toxicologist experienced with medical devices is more critical than ever. Experienced labs and experts are key to minimizing delays with market approval globally.

How does this event help to address those challenges? 

By presenting some solutions, the hope is that others can try some of the same strategies.

What are you most looking forward to at the conference? 

I always look forward to seeing people who are at the forefront of thought leadership in this area, as well as hearing about the continuing advancement. As the medical device sector is perhaps less seasoned than the pharma world when it relates to extractables and leachables, we have so much we can learn from one another’s challenges and successes.