Lex Schultheis, M.D., Ph.D.
Research Professor, Fischell Department of Bioengineering, University of Maryland

Dr. Schultheis is a research professor in the Robert E. Fischell Department of Bioengineering, and directs the Regulatory Science Initiative at University of Maryland. His role is to guide development of new scientific tools for regulatory review, building on his prior extensive experience as a clinician/engineer and FDA Branch Chief conducting premarket reviews of new drugs, devices and combination products. University of Maryland works with FDA through a Center of Excellence award from the Office of Chief Scientist. University of Maryland students developed a mobile medical application for clinical decision support in patients with life threatening illnesses. FDA designated this student project as a Humanitarian Use Device and studying a clinical population at the National Institutes of Health with the Fraunhoffer Center for Software. Another area of interest is additive manufacturing of regulated medical products. FDA is funding this work in collaboration with private industry to develop new methods to inform how biocompatible polymers are transformed chemically by subtle processes in additive manufacturing. University of Maryland students have prototyped a novel, high-speed 3D printer to study the capability of medical device manufacturing in the operating room or emergency department of a hospital. Dr. Schultheis also collaborates with large commercial firms such as Waters Corporation and Fresenius Kabi to navigate thorny regulatory and clinical obstacles in premarket applications. In addition, Dr. Schultheis provides guidance to smaller firms that are new to medical product development. For example, Flexion Therapeutics, a new, publically-traded pharmaceutical firm now has their first new drug application (505(b)(2)) (nanoparticulate) under review in FDA/CDER as a result of this work. Another Boston-based funded firm with venture funding has their first de novo medical device application under active FDA/CDRH review. A Palo Alto start-up working with Dr. Schultheis’ team at University of Maryland had their first medical device accepted in January 2017 for the FDA/CDRH Expedited Access Pathway. Within the National Children’s Center Pediatric Device Initiative, Dr. Schultheis serves as a University of Maryland coach-coordinator, providing regulatory guidance to small medical device companies receiving seed funding from the FDA Office of Orphan Products.

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