Our Leadership Team

Neal E. Fearnot, PhD, is President of MED Institute, a full service R&D company supporting clients in bringing their new medical products and technologies to market. Concurrently, he serves as President of Cook Advanced Technologies, whose mission is to develop cutting edge medical products and therapies for patients, as well as Vice President of Cook Group Incorporated, focusing on the potential of new technology and regulatory affairs policy worldwide. Dr. Fearnot has served as the founding President of MED Institute (1983), Cook Biotech (1995) and Cook AT (2009). He has been active in initiatives to promote global harmonization of medical device approval regulations. He is an author on over 150 scientific journal articles and abstracts, and is an inventor on over 100 U.S. and foreign patents. Dr. Fearnot holds a Ph.D. in Electrical/Biomedical Engineering from Purdue University.

Ted Heise, PhD,  RAC is Vice President of Regulatory and Clinical Services at MED Institute. In this capacity, with 25 years of experience, he leads the company in developing scientifically robust regulatory and clinical study strategies for its clients. He is a member of the Regulatory Affairs Professionals Society, the American Chemical Society and is a U.S. delegate to the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices. Dr. Heise is also active in developing processes to generate real world evidence for medical devices, representing Cook Medical on the corporate stakeholder board for the SVS/Vascular Quality Initiative and participating in projects within MDEpiNet (e.g., RAPID) and Harmonization by Doing. Dr. Heise graduated Magna Cum Laude with a BS in chemistry from the University of Nebraska at Omaha and a PhD in analytical chemistry from Iowa State University.

Steve Charlebois is the Vice President of Engineering at MED Institute. He began his professional career at Zimmer Inc., working as a Senior Research Engineer focused on projects involving advanced biomaterial selection, characterization and optimization for orthopaedic implant design. While at Zimmer, he also served as Project Manager for a new primary hip implant, incorporating an innovative open-porous metal foam technology, and leading the project from initial concept development through final product commercialization. Steve joined MED Institute in 2007, working as a member of the Product Discovery team, eventually assuming management responsibilities as Director of Product Discovery. He managed a large, diverse group of engineers and scientists, with projects supporting Cook’s next generation business needs in aortic and peripheral vascular intervention, urology, women’s health, surgery, and endoscopy. Steve’s MED experience included significant research focus on drug-device combinations and technical input to define priorities and set company goals for cell and regenerative therapies. In 2015, Steve joined Cook Regentec, where he served as Director, Global Research and Discovery. Steve holds a BS in Metallurgy, Mechanics, and Material Science from Michigan State, a MS in Biomedical Engineering from University of Minnesota, and a PhD in Mechanical Engineering from the University of Memphis.

Justin Metcalf is the Director of Engineering Services at MED Institute. He started his career as an engineer at MED Institute over 18 years ago and has worked on many Class II and Class III medical devices in various roles.  Many of the devices he has worked on have been first to market or have met an unmet clinical need. These experiences have allowed for development of a unique set of engineering skills. Through this, Justin has worked with regulatory bodies around the globe, has submitted several patents, worked with various physician specialties both in the engineering lab and the operating room, and participated in standardization, all of which he actively enjoys. Justin manages a diverse team of engineers that use first principles of engineering to identify and develop solutions to medical needs. The team works to bridge the gap to commercialization by using our experiences, robust processes and customer focused principles to help patients. Justin holds a BS and MS in engineering from Purdue University.