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 PohlDiscussion points include:When to perform a biological evaluation strategy in the product development processMaterial selection and biocompatibilityHow a “passing” test does not mean there won’t be reviewer questionsHow the scope of biocompatibility reaches into the development cycle and planning for biocomp can alleviate challenges down the roadIt’s never too early to start planning for the biological safety of the deviceOpinions are their own and do not reflect that of their current or former employers.

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