Don has been with NAMSA since 1993, working in a variety of roles involving the biocompatibility evaluation of medical devices. He has expertise in various therapeutic areas including but not limited to cardiovascular, orthopedics, neurostimulation, dialysis, wound management, combination products and drug delivery.

Don’s expertise is specialized in preparing strategies to address biocompatibility issues using chemical characterization data, preclinical test results, in-vitro/in-vivo biocompatibility test data, toxicological risk assessment and relevant clinical data as described in ISO 10993-1, FDA guidance and other relevant regional and international standards. He has led dozens of trainings on behalf of NAMSA and plays an active role in NAMSA’s biocompatibility-focused podcast.

Don holds a Bachelor of Science in Biology from Ohio State University. Don is a member of AAMI, Medical Alley, and serves as a member of the North American Biocompatibility Summit advisory board.

CORE COMPETENCIES

• Addressing issues involving the biocompatibility assessment of medical devices, including new devices and changes to existing devices
• Working knowledge of the U.S. Food and Drug Administration (FDA), EU Medical Device Regulation (MDR) and other global medical device regulations and all parts of the ISO 10993 series
• Developing gap assessments, risk assessments, evaluation plans and strategy documents to support the biocompatibility evaluation of devices
• Providing advice to Sponsors to support responses to FDA, Notified Bodies, Competent Authorities, NMPA and other global regulatory agencies
• Assisting in the development of pre-submission documents for the FDA with plans to address biocompatibility for various types of final submissions (e.g., IDE, PMA, 510(k), EFS, etc.)
• Presenting globally on biocompatibility and the ISO 10993 series, MDR and other vertical biocompatibility standards
• Co-hosting NAMSA’s podcast, BioCompCHATibility

 RECENT PROJECTS

• Provided virtual training for Sponsors on the basics of biocompatibility and the biocompatibility of packaging for medical devices
• Attended several meetings with the FDA discussing topics ranging from extent and type of extractables testing needed, methods to address biocompatibility of various devices, different approaches for addressing biocompatibility based on submission type and beyond
• Prepared several biological evaluation plans for the support of numerous 510(k)s and IDEs
• Prepare biocompatibility reports for several products to support MDR re-certification