Our hosts are joined by NAMSA colleague, Dr. Phil Smiraldo (Toxicologist), LIVE from the NAMSA Training Series event in Philadelphia. Sheri, Don and Phil have spent the week conducting NAMSA’s Biocompatibility Training and discuss specific questions that directed discussion during the training, as well as important takeaways resultant from attendees’ stories and experiences.
Here are just a few key messages from this podcast:
“If you can acquire good information from humans, why might you ever consider going and doing testing in a different species, right? I mean this is what we’re really concerned about is human health.” –Don Pohl; Principal Product Development Strategist, NAMSA
“I think if you are a manufacturer choosing between material A and material B, and they are both the same material, it should be considered that they may be different grade based on supplier. Also, if you have the choice between material from supplier A (with no testing at all) and a similar material from supplier B that claims USP Class VI, I think if I would probably use the one that has some biocompatibility if I was designing a medical device.” – Phil Smiraldo; Toxicologist, NAMSA
“If people ask me if it’s an introductory course, I say no, because it’s not [NAMSA Training Series]. If you don’t know anything about biocomp, you will come here and be a little out of sorts. It’s why we provide pre-reading for registrants because it can be a lot to swallow if you haven’t done any of it.” –Sheri Krajewski-Bibins; Product Marketing Manager-Biological Safety, NAMSA
“What is the difference that makes this ‘medical grade’? Whether it’s just some testing or do they offer a more?“[sic] – Phil Smiraldo
Discussion points include:
- Material information and its usefulness
- How to use clinical data for biocompatibility evaluation
- Multi-component devices
- Main takeaways from the NAMSA Trainig Series (NTS) held in Philadelphia
Also be sure to check out our Biocompatibility Strategy Navigator.
|Phillip G. Smiraldo, PhD, DABT; Toxicologist, NAMSA
Dr. Smiraldo 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), 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, 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.
|Sheri Krajewski-Bibins; Product Marketing Manager – Biological Safety, NAMSA
Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.
|Don Pohl; Principal Product Development Strategist, NAMSA
Don holds a Bachelor’s degree from Ohio State University. He has over 25 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.