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BiocompCHATibility Podcast
A Start-Up Biocompatibility Story – Prescient Surgical

A Start-Up Biocompatibility Story – Prescient Surgical

BiocompCHATibility vor 6 Jahren

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35:14

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

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.