This webinar talk will provide an overview of the regulatory process and the specific regulatory considerations and evaluation challenges for Medical XR across multiple specialties, including orthopedics, neurology, radiology, and ophthalmology. The session will provide an overview technical and clinical regulatory considerations for each specialty. Finally, the session will discuss the importance of training and adverse event reporting for the continued improvement of the applications using augmented and virtual reality.
Speakers
Laurence Coyne Ph.D.
Division Director, OHT6: Office of Orthopedic Devices, OPEQ, CDRH, FDA
Division Director, OHT6: Office of Orthopedic Devices, OPEQ, CDRH, FDA
Dr. Laurence Coyne serves as the Director of the Division of Restorative, Repair and Trauma Devices (DHT6C) in the Office of Orthopedic Devices (OHT6) and has been with FDA for over 33 years. Dr. Coyne has a Doctoral Degree in Polymer Science and Engineering from the University of Massachusetts at Amherst and a Bachelor Degree in Chemical Engineering from Tufts University.
Chris Harner MD
Clinical Deputy Office Director/OHT6: Office of Orthopedic Devices, FDA/CDRH
Clinical Deputy Office Director/OHT6: Office of Orthopedic Devices, FDA/CDRH
Christopher D. Harner MD is the current Clinical Deputy Office Director for OHT6. He joined the FDA July 21, 2021. Prior to this he was an academic orthopedic surgeon for 35 years with a very busy clinical and surgical practice. He has served on and chaired many different orthopedic organizations in his career including as a Director for the American Board of Orthopedic Surgery(ABOS 2000-2011), President of the American Orthopedic Society for Sports Medicine (AOSSM 2013) and American Orthopedic Association (AOA 2019) and induction into the AOSSM Hall of Fame(2019).
CDR Michel Janda is a biomedical engineer that joined the FDA in 2004. He specializes in the review of stereotaxic systems, computerized medical systems, augmented reality systems, bone growth stimulators, and patient matched guides. He received his master’s degree in Applied Biomedical Engineering from Johns Hopkins University and bachelor’s degrees in Biomedical Engineering and Economics from Washington University in St. Louis
Lisa Kinnard has worked at the FDA for three years as a Scientific Reviewer in the Division of Radiological Imaging Devices and Electronic Products, Office of Radiological Health, Office of Product Evaluation and Quality, Center for Devices and Radiological Health. Dr. Kinnard reviews submissions in the areas of Image Guided Surgical Planning, Computer Aided Detection and Diagnosis, 3D Printing, and Augmented, Virtual, and Mixed Reality. Additionally, she serves in the FDA’s AR/VR Working Group. Since 1993 she has worked in various areas of Radiology, where most of her research focused on Image Segmentation. Prior to coming to the FDA Dr. Kinnard was a patent examiner at the US Patent and Trademark Office, a science officer at the Congressionally Directed Medical Research Programs and a joint Post-Doctoral Fellow with the FDA and National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH). Dr. Kinnard received a Ph.D. in Electrical Engineering (E.E.) from Howard University, a M.S.E.E. from The University of Iowa, and a B.S.E.E. from Howard University.
Alex Beylin is a Senior Lead Reviewer in the Division of Ophthalmic devices (DHT1A)., OPEQ/CDRH. He received his Ph.D. in Biomedical Engineering from the Technion – Israel Institute of Technology, advised by Professor Moshe Gur in 1998. Following his Ph.D. he completed 2 years of post-doctoral training in Mount Sinai Medical Center, New York in the laboratory of visual neuroscience led by Dr. Ehud Kaplan, where specialized in optical imaging and extracellular recordings in the visual cortex. He joined the FDA in 2007, where he currently serves as the Senior Lead Reviewer of ophthalmic devices. His current activities include review of various ophthalmic devices of safety and effectiveness. He is involved in standard activities for electrical safety of phacoemulsification devices, participating in the standard working groups for optical radiation safety, electromagnetic compatibility and electrical safety of medical devices.
Ian Broverman has been a medical device reviewer at the FDA since 2011. Neurosurgical stereotaxic systems is one of his areas of expertise, and he is now applying that knowledge to augmented reality guidance systems. His pre-FDA work in medical devices have been as a research engineer and staff writer at ECRI’s journal, “Health Devices”, and as an engineer at Pfizer working on the high-profile recall of the Bjork-Shiley heart valve.
Outside of medical devices, he has worked as a robotics engineer and troubleshooter in laboratory automation, aiding dozens of genomic research sites around the world. Ian is originally from Philly, earning his BSME from Drexel. He moved West briefly to get a master’s degree in mechanical engineering from a kludged mix of UC Davis and UC Irvine before returning East.
Ryan Beams is a Physicist in the Division of Imaging, Diagnostics, and Software Reliability (DIDSR), OSEL/CDRH. He received his Ph.D. in Optics from the University of Rochester advised by Professor Lukas Novotny in 2013. Following his PhD he was awarded an National Research Council (NCR) Fellowship at the National Institute of Standards and Technology (NIST). He joined the FDA in 2018, where he currently serves as the program coordinator for the Medical Extended Reality (MXR) research program. His current research emphasizes optical characterization and the development of evaluation methods for augmented and virtual reality devices. He has authored over 30 peer-reviewed publications in the optical sciences.
