Exploring Equivalency in Biocompatibility

Operating room with monitor

Published:

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.


In 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

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Phillip Smiraldo, PhD, DABT

Phillip Smiraldo, PhD, DABT

Phillip holds a PhD in Molecular and Cellular Biology from the University of Toledo Medical Center (formerly Medical College of Ohio) and a BS in Biology from Bowling Green State University (summa cum laude; with minors in Chemistry and Italian Language). He was a Postdoctoral Fellow at the University of Texas Southwestern Medical Center (awarded two grants to support his research), authored several articles that were published in peer-reviewed journals (regarding his research of DNA repair in mammalian cells), and authored a book chapter appearing in Telomerases: Chemistry, Biology, and Clinical Applications, and has provided several oral presentations. Dr. Smiraldo's timeless experience in the medical device industry encompasses toxicology, biological safety and preclinical study design, as well as extensive preparation of biological and toxicological risk assessments for submission in countries complying with EU and US FDA regulations. Prior to his current position as Toxicologist, he was a Medical Research Scientist and Study Director (NAMSA), overseeing special/custom preclinical functional studies, preclinical safety studies and simulated-use chemistry studies.  Before joining NAMSA, Dr. Smiraldo was a Staff Toxicologist at WIL Research (approximately 2.5 years), where he was a Study Director of preclinical safety studies for pharmaceutical- and chemical-based products.