A Start-up Biocompatibility Story – Prescient Surgical

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.