Regulatory Science Tools to Accelerate Medical Device Interoperability in Integrated Clinical Environments

Speaker: Dr. Chris Scully, FDA

Short Bio:

Christopher Scully, Ph.D., is an Assistant Director in the Division of Biomedical Physics, within FDA’s Office of Science and Engineering Laboratories (OSEL), and the program coordinator for OSEL’s interoperability research program. In these roles he leads a team of engineers and scientists performing regulatory science research to develop tools for advancing patient access to innovative, safe, and effective interoperable medical devices. Dr. Scully received the B.S. degree in electromechanical engineering from Wentworth Institute of Technology, M.S. degree in biomedical engineering from Stony Brook University, and Ph.D. degree in biomedical engineering from Worcester Polytechnic Institute. 

In this talk, Dr. Scully will provide an overview of OSEL’s Regulatory Science Tools Catalog and discuss research to develop computational and bench test methods for evaluating interoperability involving 1) physiological closed-loop controllers and 2) advanced physiological monitoring algorithms.