Biocompatibility FAQ

Over the last year, the BiocompCHATibility Podcast hosts have been compiling questions asked by our listeners and training series attendees. In this episode, we will answer your frequently asked questions about all things biocompatibility—and no, we did not answer why Don is funnier than Sheri (it is definitely a growth opportunity for her).

Highlights include:

• The use of clinical data in the biological evaluation
• Completing chemistry testing before in vitro/in vivo studies
• Gathering historic data, and how much is useful to the evaluation
• U.S. FDA and DBT (dose base threshold) values
• The truth about “whole lifecycle” evaluation

“I can certainly do a preliminary risk assessment and not have any extractables testing because part of my plan might be to go do extractables testing; but that doesn’t mean I always need it.” – Don Pohl

“If you have clinical data and you are doing a preliminary risk assessment to evaluate the safety of this device, it is general information and cannot be ignored. But, if you are going to use the data to offset the need for a test, it better speak to the endpoint very specifically.” – Don Pohl

“For manufacturing, I make sure to understand what was there and what wasn’t there. Mapping the process out is important for the reader of the assessment to understand I have performed the evaluation of the manufacturing and any impact it has on biological safety.” – Don Pohl

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

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 U.S. FDA and other global regulatory bodies in their interpretation of the biological safety evaluation of medical devices. Don holds a Bachelor’s degree from Ohio State University.