Navigating Biocompatibility in Early Feasibility Studies

Operating room with monitor

Published:

July 30, 2024

Content Type:

Audio

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.

In this episode of NAMSA’s BiocompCHATibility Podcast, our hosts discuss early feasibility studies and the scope of biocompatibility necessary to get started. They highlight the importance of controlling device response in a small patient group and how this approach shapes biocompatibility considerations within the framework of risk management.

“The control measure of just having a few patients is definitely used as a reason why, in part Biocompatibility doesn’t need to be as extensive as it needs to be for a pivotal where you have hundreds of people and commercialization where you lose practically all control.” – Don Pohl

“I want to make sure I’m choosing materials that I can support in my plan that I know have a general knowledge of safety.” – Sheri Krajewski

“There’s no specific guidance that tells you what you have to do in terms of testing and what you don’t, but the concept is you’re going to creep up on everything you’ll do. You’ll do some biocomp for early feasibility.” – Don Pohl

Key Discussion Points:

  • Crafting a dynamic biological safety plan that evolves over time
  • Establishing a robust evaluation strategy from the beginning to prevent missing important tests later
  • Designing studies for high-risk cardiovascular implants and the importance of addressing biocompatibility and safety concerns

 

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Sheri Krajewski

Sheri Krajewski

Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. Sheri has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s Biological Safety Consulting business. Additionally, she created the much sought-after NAMSA Training Series (NTS) for the iological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl

Don Pohl

Don Pohl is currently the Manager of Biological Safety & Validation at NAMSA. He holds a Bachelor’s degree from Ohio State University. Don has over 20 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.

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