In this episode our hosts are joined by Jeremy Koehler, Director of R&D for Prescient Surgical. Prescient Surgical is a small medical device company in the San Francisco area, with a biocompatibility story to tell.

Their first product submitted to the FDA, although not a high risk device, encountered delays directly related to some biocompatibility testing and the program. As a young start-up this can be very time consuming and most of all expensive.

“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 and why we did it and why it was appropriate and sufficient.” – Jeremy Koehler

“Kind of 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’s plenty of projects that I’m involved in where I tell people; 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
• Material selection and biocompatibility
• 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 biocomp can alleviate challenges down the road
• It’s never too early to start planning for the biological safety of the device

Opinions are their own and do not reflect that of their current or former employers.