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BiocompCHATibility Podcast
Exploring Equivalency in Biocompatibility

Exploring Equivalency in Biocompatibility

BiocompCHATibility vor 2 Jahren

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39:57

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

n this episode of NAMSA’s BiocompCHATibility podcast, we welcome
back Dr. Phil Smiraldo (Principal Toxicologist, NAMSA) for his
third appearance as an honorary host. The discussion centers on
the complexities of equivalency in biocompatibility, examining
how equivalency can range from simple to complex and how a
predicate device does not always equal equivalency.

Listen in as we explore these topics with Dr. Smiraldo and gain
insights into the intricate world of biocompatibility and the
challenges faced when trying to establish equivalence between
medical devices.

“The world of equivalency runs the spectrum from incredibly
simple to probably way too complex.” – Don Pohl

“When we do these types of extractions on, we'll say prior
devices and change to device, we're going to have variability
within our experiments.” – Phil Smiraldo

“You know whether you call it an equivalency assessment or change
control assessment. Whatever you want to call it, I mean [10993]
part one tells us if there's a change, you have to evaluate it.”
– Don Pohl

“I guess long story short, you could theoretically go through
this whole exercise and end up with the two devices that are
equivalent from a systemic toxicity perspective and that's it.” –
Phil Smiraldo

Key Discussion Points

Importance of confirming identical materials of construction,
device categorization, and the IFU to ensure that the device
remains equivalent

The detailed process required to establish proof of
equivalence

The critical role of adhering to standards in
biocompatibility assessments