Executive Team
Former Director, Office of Health Technology 1, Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration.
Malvina Eydelman, MD, CEO
Dr. Eydelman guided the development of more than 50 international and national standards, oversaw the development of numerous regulations and guidance; and convened over 30 public meetings of US FDA Medical Device Committees. She originated numerous symposia and workshops to facilitate device innovation and has been instrumental in expediting the development of novel endpoints for clinical trials of pioneering technologies. Dr. Eydelman has organized multi-stakeholder public-private partnerships and spearheaded many clinical and laboratory studies designed to improve the safety of medical devices.
Dr. Eydelman received her MD degree from Harvard Medical School and a Doctorate in Health Sciences and Technology from Massachusetts Institute of Technology (M.I.T.). Dr. Eydelman has been granted a US patent, published nearly 100 peer-reviewed articles, book chapters, and monographs, and presented over 200 lectures worldwide.
Joel S. Schuman, MD, FACS,
PRESIDENT AND CHAIRMAN OF THE BOARD
Chair of Personally Identifiable Information/ Protected Health Information Working Group
Dr. Schuman is the Elaine Langone Professor of Ophthalmology and Professor of Neuroscience and Physiology, Biomedical Engineering, Electrical & Computer Engineering and Neural Science at NYU. He chaired the ophthalmology department at NYU 2016–2020 and at the University of Pittsburgh/UPMC 2003–2016. At Tufts University 1991–2003 he was Residency Director and Glaucoma and Cataract Service Chief.
Dr. Schuman and his colleagues were the first to identify a molecular marker for human glaucoma, published in Nature Medicine in 2001. Continuously funded by the National Eye Institute as a principal investigator since 1995, he is an inventor of optical coherence tomography (OCT), used worldwide for ocular diagnostics.
Dr. Schuman has published more than 400 peer-reviewed scientific journal articles. Dr. Schuman has received numerous awards and is a 2012 Champalimaud Award Laureate.
Kenneth L. Roper, MD Endowed Chair and Professor of Ophthalmology, Vice Chair for Research Innovation, Co-Director, Glaucoma Service, Wills Eye Hospital Thomas Jefferson University, Professor of Biomedical Engineering, Drexel University School of Biomedical Engineering, Science and Health Systems
Mark Blumenkranz, MD MMS, PAST PRESIDENT
Dr. Blumenkranz is also the Managing Director of Lagunita Biosciences, an early-stage healthcare incubator, and CEO of Kedalion Therapeutics.
He has a long-standing interest in the area of university-industry technology transfer as well as ophthalmic laser delivery systems, ocular pharmacology, gene therapy, and health information technology. He is the recipient of multiple distinguished awards in the field including the AAO and AJO’s Edward Jackson Award Lecture and most recently Stanford’s Albion Walter Hewlett Award, and the author of more than 160 scientific papers and multiple patents in the field.
He served as the Chairman of the Department of Ophthalmology at Stanford from 1997 until 2015 and played a leading role in the planning, fundraising, and construction of the Byers Eye Institute.
HJ Smead Professor Emeritus, Co-Director of the Ophthalmic Innovation Program, Byers Eye Institute, Stanford University School of Medicine
David Myung, MD, PhD, VICE PRESIDENT
Chair of Education Working Group
Dr. Myung is a clinician-scientist specializing in cataract and corneal surgery and external diseases of the eye. He serves as the Director of the Ophthalmic Innovation Program at the Byers Eye Institute at Stanford which includes a project-based fellowship in the development and regulatory science of new eye care technologies.
Dr. Myung leads an NIH-funded translational research laboratory focused on two areas of clinical need: (1) ophthalmic regenerative medicine and (2) telemedicine through ophthalmic imaging and digital health technologies. As Director of the Stanford Teleophthalmology Autonomous Testing and Universal Screening (STATUS) program at Stanford, he organized and leads an AI-powered remote screening network for diabetic retinopathy based out of primary care clinics throughout the Bay Area and led the development of a smartphone-based ophthalmic imaging system which has been studied in numerous clinical settings both in the US and abroad.
Associate Professor of Ophthalmology and, by courtesy, Chemical Engineering, Director—Ophthalmic Innovation Program, Director—STATUS program, Byers Eye Institute at Stanford
Michael Abramoff, MD, PhD, Treasurer
Chair of Foundational Principles of Artificial Intelligence Working Group
Dr. Abramoff is an American ophthalmologist, computer scientist, and entrepreneur. He is the Founder and CEO of Digital Diagnostics (formerly IDx), the first company ever to receive US FDA clearance for an autonomous AI system. In this capacity, as an expert on AI in healthcare, he has been invited to brief the US Congress, the White House, and the Federal Trade Commission.
Dr. Abramoff has published over 250 peer-reviewed journal papers (h-index 54) on AI, image analysis, and retinal diseases, and many book chapters. In 2010,
Dr. Abramoff’s research findings led him to found IDx to bring to patients more accessible, affordable, and higher quality healthcare.
Robert Watzke Professor in Retina Research and Electrical and Computer Engineering, University of Iowa School of Medicine, Founder and Executive Chairman, Digital Diagnostics (formerly IDx)
Ted Stiefel, CFO
Ted Stiefel is finance executive, overseeing accounting, financial operations, and strategic planning. He drives forecasting, capital allocation, and performance management to support high-growth companies.
Ted has led finance teams across SaaS, biotech, private equity, and real estate. A CPA with an MBA in Finance & Entrepreneurship from San Diego State University, he blends technical expertise with strategic insight to scale companies during rapid growth.
Don Calogero, MSE, Director of Standards Strategy
Don has 35 years’ experience developing clinical and non-clinical ISO and ANSI standards for ophthalmic implant devices and has served as chairman of multiple clinical and non-clinical standards. He has led a World Health Organization (WHO) effort to publish guidelines for the manufacture of IOLs in developing countries.
Don has review experience performing high level IOL clinical study design evaluations for consistency with FDA recognized standards, determining clinical requirements/ non-clinical testing associated with IOL design modifications, and evaluating specular microscopy data in IOL and MIGS device studies. He earned his Master of Science in Biomedical Engineering from SUNY at Stony Brook.
Biomedical Engineer who served as a senior reviewer and lead reviewer in the ophthalmic implants branch of the FDA/CDRH Division of Ophthalmic Devices for 44 years.