Our hosts are joined this week by Stephanie Taylor, Staff Scientist – Toxicology and Biocompatibility at DePuy Synthes Companies. During this episode, the team discusses the reprocessing of reusable devices and the challenges of the ever-changing landscape of biological evaluation. As activity is requested both by the U.S. FDA and the EU that greatly impacts the timelines and costs of evaluating reusable devices for biological safety, the team shares a few strategies and practices used by manufacturers today to meet these high regulatory expectations.
“The end goal is a defensible position.” – Stephanie Taylor
“The magic number 6? I don’t know if that’s justifiable.” – Don Pohl
“What’s your biocomp at the end of life? You have to be able to figure that out.” – Stephanie Taylor
“Biocomp is interesting, challenging and a little bit magical at times.” – Stephanie Taylor
Discussion points include:
- The large concern with reusable devices and why
- Differentiation between an end-of-life evaluation and what might be expected currently by the U.S. FDA
- The great cost and time involved in such evaluations and burdens on manufacturers
Also be sure to check out our Biocompatibility Strategy Navigator.
|Stephanie Taylor; Staff Scientist – Toxicology and Biocompatibility, DePuy Synthes
Stephanie Taylor has over 20 years of experience in the preclinical evaluation of medical devices. During her career, she has worked for both CROs and Medical Device Manufacturers in various roles relating to assessing the biocompatibility of medical devices. Her expertise is specifically around ISO 10993 and the expectations of regulatory bodies worldwide for both single use and reusable medical devices. Her opinions are her own and do not reflect that of her current or former employers.
|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.