Editor Chat: Biocompatibility and Performance of Medical Devices

BiocompCHATibility

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

Our hosts are joined this week by Dr. Jean Pierre Boutrand, VP of North American Laboratory Services at NAMSA. During this episode, the team discusses the new book, Biocompatibility and Performance of Medical Devices. Jean Pierre is the Editor of this collection of experiences by esteemed authors in the biocompatibility and medical device profession. This is the second edition of the book, originally published in 2012, and the focus of the new edition is how to accelerate a product to market and ways to plan for evaluation.

From the book cover “Biocompatibility and Performance of Medical Devices, Second Edition, brings an understanding of evaluation strategies for ensuring that medical devices and biomaterials are safe and effective and will perform as expected in the biological environments. This second edition is updated and expanded to include the latest developments in nonclinical research to support rapid market introduction of innovative medical devices and biomaterials.”

Discussion points include:

Pertinent changes since the 2012 edition that effect today’s market
How experts and topics were chosen for this edition of the book
How listeners can win a free copy of the new book
The inspiration and motivation for this type of book in the industry

Also be sure to check out our Biocompatibility Strategy Navigator.

Dr. Jean Pierre Boutrand

Dr. Jean Pierre Boutrand has held various positions at NAMSA, including Study Director, Pathologist, Director of Operations, General Manager and Scientific Director. Prior to joining NAMSA he was involved in research and teaching functions in the academia. Dr. Boutrand received his DVM from the National Veterinary University of Lyon, France in 1993 and a certificate in Toxicology Pathology in 2000. He also received degrees in the study of Biomaterials and Medical Device Regulations from the University of Paris in 1998. Dr. Boutrand has been involved in more than 60 public presentations or publications on topics related to the pre-clinical or clinical evaluation of medical devices. He is also registered as an expert on biological safety of medical devices for a national health agency.

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 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.

Editor Chat: Biocompatibility and Performance of Medical Devices

Published:

BiocompCHATibility

Dr. Jean Pierre Boutrand

Sheri Krajewski

Don Pohl

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