NAMSA Training Series: Live from Philadelphia
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.