In this episode, our hosts are joined by Jeremy Koehler, Director of R&D for Prescient Surgical, a small, San Francisco-based medical device company focused on advanced tools and technologies to fight and defend surgical site infections. When Prescient Surgical’s first device, was submitted to the U.S. FDA for clearance, they encountered unfortunate delays due to missteps taken by their previous biocompatibility testing partner, which ultimately cost them time and money.
Access NAMSA’s latest podcast episode to better understand lessons learned by Prescient Medical, and how NAMSA was able to guide Prescient Medical to a better understanding of biocompatibility evaluation requirements.
“As a small company, speed is everything and time is a precious commodity.” – Jeremy Koehler
“Externally communicating, limited contact. What more is there to talk about? What gives? As it played out, it got a little bit more interesting.” – Don Pohl
“The challenge came when we didn’t really have a good scientific justification for what we’d done, why we did it and why it was appropriate and sufficient.” – Jeremy Koehler
“The moral here is to have a solid scientific plan to help you down the road.” – Sheri Krajewski-Bibins
“It’s important to mention that not every change triggers new testing.” – Jeremy Koehler
“There are plenty of projects that I’m involved in where I tell people that you don’t have to do testing, you have to address biocomp, but that doesn’t always mean testing.” – Don Pohl
Discussion points include:
- When to perform a biological evaluation strategy in the product development process
- How material selection is critical to biocompatibilty
- How a “passing” test does not mean there won’t be reviewer questions
- How the scope of biocompatibility reaches into the development cycle and planning for biocompatibility testing can alleviate challenges down the road
- When to plan for the biological safety of the device
Also be sure to check out our Biocompatibility Strategy Navigator.
|Jeremy Koehler; Director of R&D, Prescient Surgical
Jeremy Koehler has been an integral part of the development, engineering and manufacturing of the CleanCision Wound Retraction and Protection System from the initial hand sketches to commercial launch. Trained as a mechanical engineer, he has commercial medical device experience at Biomet Orthopedics (now Zimmer Biomet), as well as various academic projects focused on treating a range of conditions in gastro-intestinal, cardiology and musculoskeletal specialties. Jeremy received a BS and MS in Mechanical Engineering from Purdue University and University of Michigan, respectively, and completed the Biodesign Innovation Fellowship program at Stanford University.
|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.