Why Biocompatibility Cares about Preclinical: NAMSA and APS Discuss

Operating room with monitor

Published:

BiocompCHATibility

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


In this episode, our hosts are joined by APS’s Senior Director of Biocompatibility Services, Dr. Yan Chen, to discuss NAMSA’s acquisition of APS and the importance of preclinical studies in the biological evaluation of medical devices.

This podcast discussion revolves around the many synergies of the combined companies, as well as a technical discussion regarding preclinical studies, preclinical study biocompatibility endpoints and of course, an energetic game of ‘2 Truths and a Lie’ that will surely bring you a laugh.

“We have expanded the possibilities of people who can join us now.” – Sheri Krajewski-Bibins

“We are very excited. We firmly believe that both companies share the same goals to provide high-quality, comprehensive services for medical device development.” – Dr. Chen

“Companies are beginning to think about biocompatibility when they should early-on with studies like these. These [preclinical] studies can be so powerful in so many ways.” – Don Pohl

“The local tissue response is the most commonly used (biocomp endpoint) used in the preclinical study. Sometimes you want a clinically relevant implant site. That is something to keep in mind to combine (preclinical and biocomp) studies.” – Dr. Chen

Discussion points include:

  • The importance of preclinical testing to the biological evaluation
  • Early-stage preclinical studies vs. GLP studies and the value they bring to medical device regulatory submissions
  • The challenges of combining preclinical and biocomp studies

*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.

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.

Yan Chen, PhD

Yan Chen, PhD

Dr. Chen is the former Sr. Director of Biocompatibility Services at American Preclinical Services (APS). She received her Ph.D. in Pharmacology from the University of Illinois and has more than 18 years of experience in preclinical testing in both pharmacology and biocompatibility. Dr. Chen serves as the primary voting member on multiple ISO/TC194 working groups.