Biocompatibility FAQ

BiocompCHATibility vor 5 Jahren

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32:32

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

Over the last year, the BiocompCHATibility Podcast hosts have
been compiling

questions asked by our listeners and training series attendees.
In this episode, we

will answer your frequently asked questions about all things
biocompatibility—and

no, we did not answer why Don is funnier than Sheri (it is
definitely a growth

opportunity for her).

Highlights include:

The use of clinical data in the biological evaluation

Completing chemistry testing before in vitro/in vivo studies

Gathering historic data -and how much is useful to the
evaluation

U.S. FDA and DBT (dose base threshold) values

The truth about “whole lifecycle” evaluation

“I can certainly do a preliminary risk assessment and not have
any extractables

testing because part of my plan might be to go do extractables
testing; but that

doesn’t mean I always need it.” – Don Pohl

“If you have clinical data and you are doing a preliminary risk
assessment to

evaluate the safety of this device, it is general information and
cannot be ignored.

But, if you are going to use the data to offset the need for a
test, it better speak to

the endpoint very specifically.” – Don Pohl

“For manufacturing, I make sure to understand what was there and
what wasn’t

there. Mapping the process out is important for the reader of the
assessment to

understand I have performed the evaluation of the manufacturing
and any impact

it has on biological safety.” – Don Pohl