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BiocompCHATibility Podcast
Why biocompatibility cares about preclinical: NAMSA and APS discuss

Why biocompatibility cares about preclinical: NAMSA and APS discuss

BiocompCHATibility vor 5 Jahren

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49:20

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, our hosts are joined by APS’s Senior Director of
Biocompatibility Services, Dr. Yan Chen, to discuss NAMSA’s
acquisition of APS and the importance of preclinical studies in
the biological evaluation of medical devices.

This podcast discussion revolves around the many synergies of the
combined companies, as well as a technical discussion regarding
preclinical studies, preclinical study biocompatibility
endpoints, and of course, an energetic game of ‘2 Truths and a
Lie’ that will surely bring you a laugh.

“We have expanded the possibilities of people who can join us
now.”-Sheri Krajewski

“We are very excited. We firmly believe that both companies share
the same goals to provide high-quality, comprehensive services
for medical device development.” – Dr. Chen

“Companies are beginning to think about biocompatibility when
they should early-on with studies like these. These [preclinical]
studies can be so powerful in so many ways.” – Don Pohl

“The local tissue response is the most commonly used (biocomp
endpoint) in the preclinical study. Sometimes you want a
clinically relevant implant site. That is something to keep in
mind to combine (preclinical and biocomp) studies.” – Dr. Chen

Discussion points include:

The importance of preclinical testing to the biological

evaluation

Early-stage preclinical studies vs. GLP studies and the value

they bring to medical device regulatory submissions

The challenges of combining preclinical and biocomp studies