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BiocompCHATibility Podcast
Reusable devices and the challenges with biocompatibility

Reusable devices and the challenges with biocompatibility

BiocompCHATibility vor 6 Jahren

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29:21

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

Our hosts are joined this week by Stephanie Taylor, Staff
Scientist - Toxicology and Biocompatibility at DePuy Synthes
Companies. During this episode the team discusses the
reprocessing of reusable devices and the challenges of the ever-
changing landscape of the biological evaluation of such devices.

There is activity requested both by the USDA and the EU that
greatly impacts the timelines and costs of evaluating these
devices for biological safety, so the team shares some strategies
and practices used by manufacturers today to meet high regulatory
expectations.

“The end goal is a defensible position.” -Stephanie Taylor

“The magic number 6? I don’t know if that’s justifiable.” - Don
Pohl

“What’s your biocomp at the end of life – you have to be able to
figure that out.” - Stephanie Taylor

“Biocomp is interesting, challenging and a little bit magical at
times.” – Stephanie Taylor

Discussion points include:

Why the great concern with such devices?

The differentiation between an end of life evaluation and
what might be expected currently by the USFDA.

The great cost and time involved in such evaluations and
burdens on manufacturers.

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