Eric Sussman

About Eric Sussman

Pre-clinical medical device testing can be expensive and time-consuming, but is often critical for demonstrating device safety and ultimately achieving regulatory success. Leveraging my background as a Ph.D. biomedical engineer and experience as a former FDA biocompatibility reviewer and researcher, I assist my clients in navigating the selection, design, analysis, and submission of pre-clinical testing, with focus on the topics of biocompatibility, chemical characterization, toxicology, materials science, and nanotechnology. As an independent advisor, I can assist in navigating the complex task of contract laboratory selection and method development, working with the world’s experts to design the right studies for your needs, and drawing upon the deep regulatory and clinical knowledge and experience of my colleagues to find the best solutions.With 15+ years of experience in biomaterials science, biocompatibility, and regulatory affairs, I provide biocompatibility consulting services to medical device manufacturers for US FDA and international regulatory submissions. This includes strategy, design, review, and remediation of ISO 10993 biocompatibility evaluations, chemical characterization (extractables and leachables testing), toxicological risk assessment, biological testing, and nanotechnology evaluation of devices. I provide tailored strategy advice and services based on regulatory history and submission type including q-sub, 510(k), de novo, clinical study (IDE) and PMA submissions.Prior to joining MCRA, I served for ten years at US FDA as a regulatory scientist in the Office of Science and Engineering Laboratories (OSEL) of the Center for Devices and Radiological Health (CDRH). My responsibilities included consulting review for biocompatibility with focus in the areas of chemical characterization, toxicological risk assessment and nanotechnology across medical therapy areas and submission types. Specifically, I acquired extensive experience in the biocompatibility review of dental, respiratory, cardiovascular (including electrophysiology, monitoring, circulatory support, structural, vascular, coronary, and peripheral intervention devices), surgical and infection control, plastic and reconstructive surgical, neurological, orthopedic (including joint arthroplasty, spinal, and restorative devices), and imaging devices. I also have experience with CDRH-led and CDER-led combination product reviews.

Experience

1. Director, Biocompatibility

   MCRA, an IQVIA business

   Apr 2024 — Present · Washington, DC, US

Education

• University of Pennsylvania

  B.S.E., Bioengineering with Materials Science minor

  2001 — 2005

• University of Washington

  Ph.D., Bioengineering

  2005 — 2011