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BiocompCHATibility Podcast
Is Your BioCompatibility Program Knocking Your Submission Off Track?

Is Your BioCompatibility Program Knocking Your Submission Off Track?

BiocompCHATibility vor 5 Jahren

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42:59

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, our guests are joined by Syntactx’s Dr. Valerie
Merkle, Associate Director – Regulatory Strategy, to discuss
NAMSA’s recent acquisition of Syntactx.

During this one-hour installment, Dr. Merkle discusses her
deep-rooted experience at the FDA and the importance of proper
biological safety planning to achieve biomechanical efficiency
and successful clinical trial execution. Examples will be
provided regarding how and when biocompatibility programs go
wrong, which often result in derailment of development efforts.
How can manufacturers create biocompatibility programs that are
observed favorably by the FDA? Learn helpful tips and strategies
to help ensure a successful FDA submission.

“We really wanted to mirror what we were doing at the FDA.” –
Valerie Merkle

“You just never know what is going to come in next. It keeps you
on your toes for sure.” – Don Pohl

“People think biocomp is just a checklist, but there are a lot of
rabbit holes you can go down—a lot of ways you can stray off the
path unnecessarily. Definitely not a checklist item.” – Valerie
Merkle

“Make good decisions early-on to not derail yourself later.” –
Sheri Krajewski-Bibins

“A lot of companies don’t want to provide their thought process.
They spend years and years developing and making decisions, FDA
only sees what is in front of them and if the background is not
there, we see lots of questions.” – Valerie Merkle

Discussion points include:

Syntactx company overview and strengths they bring to NAMSA

Material selection and its importance in avoiding derailment
of biocompatibility projects

FDA experiences with manufacturers overlooking material
testing

FDA biocompatibility guidance and its role in regulatory
submissions