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; Vice President, North American Laboratory Services, NAMSA
After joining Biomatech, a clinical and non-clinical CRO in 1996, Dr. Jean-Pierre Boutrand worked as a Study Director, Department Head, Pathologist, Director of Operations, General Manager and Scientific Director for NAMSA. He became Vice President, Global and International Sales, before moving to a role of Vice President, N.A. Laboratory Services.
Dr. Boutrand received his DVM from the National Veterinary University of Lyon, France in 1993 and certification in Toxicology Pathology in 2000. He also received degrees in the study of Medical Devices Global Regulations from the University of Paris in 1998. He has been an evaluation expert for medical devices for a national health agency ANSM. Dr. Boutrand was initially involved in research and teaching functions in the academy. He has been involved in more than 150 public presentations or publications on topics related to the pre-clinical or clinical evaluation of medical devices.
Connect with Jean Pierre here at https://www.linkedin.com/in/jean-pierre-boutrand-4460a57/
|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 holds a Bachelor’s degree from Ohio State University. He has over 25 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.