A Start-up Biocompatibility Story – Prescient Surgical

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 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.

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.