With approximately 20 years of experience related to biocompatibility, biomaterials science, and regulatory affairs, Dr. Sussman is a Director for Biocompatibility at MCRA with focus on biocompatibility strategy, including chemical characterization and toxicological risk assessment.
Dr. Sussman completed a Postdoctoral ORISE Fellowship at the U.S. Food and Administration in which he studied the intersection of nanotechnology and biocompatibility. Dr. Sussman received his doctorate from the University of Washington (Seattle, WA) in Bioengineering with a research focus on the host response to implanted biomaterials. He also received a Bachelor of Science in Engineering from the University of Pennsylvania (Philadelphia, PA) with a major in Bioengineering and a minor in Materials Science and Engineering.
Prior to joining MCRA in 2022, Dr. Sussman served for ten years at FDA as a regulatory scientist in the Office of Science and Engineering Laboratories (OSEL) of the Center for Devices and Radiological Health (CDRH). His responsibilities included consulting review of biocompatibility (including chemical characterization and toxicological risk assessment) and nanotechnology of submissions across medical therapy areas and submission types, including combination products. Dr. Sussman also led research efforts as Principal Investigator and co-PI in areas including evaluation of metal ion release from medical devices, biological response to polymer wear debris, and chemical characterization for biocompatibility evaluation. Dr. Sussman served as technical contact and technical expert for ASTM standards that address characterization and biological evaluation of medical device particulates (ASTM F1877) and served on several FDA committees on biocompatibility evaluation and contributing to biocompatibility related ISO 10993 and ASTM standards. Dr. Sussman is a member of the Society for Biomaterials (since 2011) and the Society of Toxicology (since 2018) and has served in multiple leadership roles including Vice Chair, Chair, and Program Chair of the Biomaterials and Medical Products Commercialization Special Interest Group and annual meeting program committee.
Overview
Dr. Sussman develops and executes biocompatibility services, including Biological Evaluation Plans (BEP) and Reports (BER), and biocompatibility sections in US regulatory submissions (510(k), De Novo, IDE, PMA and combination product) and international regulatory submissions. This work includes strategy, design, implementation, analysis, and review of biocompatibility evaluations including biological testing, chemical characterization, and toxicological risk assessments. Prior to joining MCRA in 2022, Dr. Sussman served for ten years at CDRH as a regulatory scientist leading research and providing consulting review of biocompatibility of medical devices and combination products.