Listener Mailbag – We Answer Your Questions

In this episode, our hosts answer your questions about biocompatibility.  After 15 episodes of discussing what we think is important surrounding this topic, we asked for your questions and created this special episode to answer them.

“A toxicological risk assessment is the process of focusing on the risk associated with the chemicals that are in or may come out of a device, that’s your primary focus.” – Don Pohl

“The first step to investigation is trying to understand root cause […] what went into to my device that might cause this response.”  – Don Pohl

“I love the ever changing environment, and I’m excited about us (the industry) getting better at performing evaluations that minimize unnecessary testing,” – Sheri Krajewski-Bibins

“The reality is, if you look at the grand scheme of things, it (biological evaluation of medical devices) is relatively new in terms of what we are doing – it’s constantly evolving and changing.”  – Don Pohl

Discussion points include:

• Updates on In Vitro alternative testing
• How to handle unexpected biocompatibility results
• What genotoxicity methods are preferred by the FDA
• Alternative extraction temperatures accepted by the FDA
• Differences between a toxicological risk assessment and a biological risk assessment

The future of biological safety evaluations – an exciting outlook

Also be sure to check out our Biocompatibility Strategy Navigator.

Meet the Speakers

Sheri Krajewski-Bibins; Product Marketing Manager – Biological Safety, NAMSA

Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She 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, Sheri created the much sought-after NAMSA Training Series for the biological 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; Principal Product Development Strategist, NAMSA

Don has over 25 years of experience in the preclinical 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. Don holds a Bachelor’s degree from Ohio State University.