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Finding the Qualified Biocompatibility Unicorn


In this episode, our hosts are joined by Nicole Soucy, PhD, DABT from Boston Scientific to discuss qualifications of expert assessors and other personnel qualified to make biological evaluation decisions for medical devices.

Documents including ISO 10993-1, Medical Device Regulation (MDR) documentation submissions and BSI best practice guidelines recommend having a qualified individual make decisions for the biocompatibility of medical devices. While many testing organizations claim to perform this work, what does “qualified” really mean and how do companies determine this qualification? In this episode, our experts discuss hiring and training processes utilized to identify and grow qualified individuals within their organizations.

“What are the qualifications that a person needs to have to evaluate the biocompatibility of a device? We get questioned about it all the time.” – Don Pohl

“Anytime you have a position open…you’re looking for that needle in a haystack to find someone who is appropriately qualified and has a good, strong background.” – Nicole Soucy

“You are not going to go out and find someone who has a Bachelor’s or Master’s degree—or even a PhD—in medical device biocompatibility; those people don’t exist. There is definitely an on-the-job training component to growing and developing this skill set.” – Nicole Soucy

“A really critical partner in all of this is your analytical chemist. They need to be integrated into you team. You need to have strong chemistry support all the way through your project.” – Nicole Soucy

Discussion points include:

  • How this role is the “famed unicorn” of medical device development
  • How on-the-job training is a critical component to successful assessors
  • How long until an assessor is able to work independently on a plan and assessment
  • Challenges with regulators utilizing an assessment properly
  • What someone looks for when choosing a qualified individual to perform this work

*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


Dr. Nicole Soucy; Director Global Pre-Clinical Sciences Biocompatibility and Toxicology, Boston Scientific

Nicole received a PhD in pharmacology and toxicology from Dartmouth College in 2003 and has worked in the medical device industry since 2006 following completion of a post-doctoral fellowship at the Chemical Industry Institute of Toxicology (CIIT).  In the course of her career, Nicole has designed and managed preclinical safety programs to support IDE/PMA submissions for stent and balloon based drug delivery programs, led technology development projects to support the biological evaluation of combination medical device products, and has led teams of toxicologists and biocompatibility specialists for two major medical device manufacturers, including divisions with contract pharmaceutical R&D and manufacturing operations.

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.