BiocompCHATibility

In this episode our hosts are joined by Jeremy Koehler, Director of R&D for Prescient Surgical. Prescient Surgical is a small medical device company in the San Francisco area, with a biocompatibility story to tell. Their first product submitted to the FDA, although not a high risk device, encountered delays directly related to some biocompatibility testing and the program. As a young start-up this...

In this special release episode, our hosts are joined by Dr. Phil Smiraldo, Toxicologist at NAMSA. During this episode the team discusses the current pandemic situation of Covid 19 and the production of ventilators and respirators to help treat and prevent spread of this virus. With companies like Dyson, Ford, GMC and others discussing the design and/or manufacture of ventilators to meet the growi...

Our hosts are joined this week by Stephanie Taylor, Staff Scientist - Toxicology and Biocompatibility at DePuy Synthes Companies. During this episode the team discusses the reprocessing of reusable devices and the challenges of the ever- changing landscape of the biological evaluation of such devices. There is activity requested both by the USDA and the EU that greatly impacts the timelines and co...

During this episode, our hosts are joined by Andy Wyen, Toxicologist at NAMSA, to answer questions received during NAMSA’s live Webinar on the new ISO 10993-18:2020. As this new standard is a complete re-write from the 2005 version, it is stirring up industry and leaving many manufacturers confused and searching for the most efficient adoption methods. Topics include: Triplicate testing and how to...

Our hosts are joined this week by David Parente, Director of Global Sterilization at and Biological Safety at Ecolab.  During this episode the team discusses Dave’s chapters in the new book, Biocompatibility and Performance of Medical Devices .  Dave has a long history with the biological evaluation process, including founding NAMSA’s first biological safety consulting team, NAMSA Advisory Service...

Our hosts are joined this week by Dr. Ted Heise, convenor of TC 194/WG 14 responsible for the re-write and release 10993-18 Biological evaluation of medical devices —Chemical characterization of medical device materials within a risk management process. This much-anticipated standard is expected to provide greater detail and guidance to the use of characterization within the biological evaluation...

Our hosts are joined this week by Dr. Jean Pierre Boutrand, VP of North American Laboratory Services at NAMSA.  During this episode the team discusses the new book, Biocompatibility and Performance of Medical Devices .  Jean Pierre is the Editor of this collection of experiences by esteemed authors in the biocompatibility and medical device profession.  This is the second edition of the book, orig...

Our hosts are joined this week by NAMSA colleagues, Dr. Sylvie Framery and Dr. Nicolas Martin  – LIVE from the NAMSA training series event in Frankfurt, Germany.  Sheri, Dr. Martin and Dr. Framery have spent the week conducting NAMSA’s biocompatibility training, and discuss the week’s events, the specific questions that seemed to drive the training this week, and any new awareness received from he...

Our hosts are joined this week by NAMSA colleague, Dr. Phil Smiraldo – LIVE from the NAMSA training series event in Philadelphia.  Sheri, Don and Phil have spent the week conducting NAMSA’s biocompatibility training, and discuss the week’s events, the specific questions that seemed to drive the training this week, and any new awareness received from hearing attendee stories and experiences.  Discu...

Lisa Olson, NAMSA’s Global Director of Analytical Services joins Sheri and Don on this special episode.  As Lisa is a recent addition to the NAMSA team, our hosts ask about her background, her thoughts on the future and present state of biocompatibility, and most specifically the use of chemical characterization in the biological evaluation strategy.  The hosts also introduce a new game of 2 truth...

Access NAMSA testing resources here at www2.namsa.com/csipodcast. There are many mentions of extractions throughout international testing standards and regulations. In this episode, ISO 10993-12 for sample preparations and extraction conditions is discussed. What happens to a sample when it’s received at a lab prior to testing? How does the lab actually extract a piece of plastic and when has the...

Cytotoxicity, sensitization and irritation, sometimes known as CSI, are three of the most common tests performed on medical devices. In this episode, our hosts discuss these tests, common pitfalls and how to address regulatory expectations.  Opinions are their own and do not reflect that of their current or former employers.

In this first episode of BiocompCHATibility, hosts Sheri Bibins (Product Marketing Manager) and Don Pohl (Principal Product Development Strategist) of NAMSA discuss this first-of-its-kind podcast dedicated to all things medical device biocompatibility. Access NAMSA podcasts and transcripts here at www.namsa.com/resources/podcasts Opinions are their own and do not reflect that of their current or f...