The members of the Blueprint MedTech (BPMT) External Oversight Committee (EOC) are an external advisory group of industry, clinical, regulatory, non-profit, insurance and academic experts in device development and translation directed to provide independent advice to the NIH program staff and scientific and strategic inputs for its current projects. They have executive-level expertise in therapeutic and diagnostic medical devices development experience, with experience in portfolio-level decision making in both academia and industry.
As individuals, the EOC members provide their perspectives independently on the oversight, strategy, and implementation of the BPMT program, including strategies for overall portfolio management, developing and improving the program, and addressing problems as they arise. Based on their deep understanding of the medical device technology development process, the members provide feedback on NIH plans for project progression based on developing suitable milestones and monitoring project plans and milestone progression for individual teams and the BPMT program.
As a link to the neurotherapeutic medical device development research community, the EOC will help the BPMT program adjust to changing landscapes to continue to provide a unique community scientific resource. Membership on this committee may be supplemented with ad hoc participation of individuals with expertise appropriate for specific programmatic matters within the BPMT program.
Amy Kruse, PhD
Amy Kruse, PhD is an internationally recognized, award-winning thought leader for strategic business development focused on improving human health and performance through application of neuroscience and technology with over 20 years of experience in R&D, innovation, and funding cutting-edge science. She is the General Partner and Chief Investment Officer for Satori Neuro and the founder and President of Sattva Science LLC, and was previously General Partner at Prime Movers Lab a deep tech venture fund with a focus in human augmentation; Chief Scientific Officer for Optios, an applied neuroscience research organization that translates cutting-edge neuroscience discoveries into practical tools; Strategic Advisor and previously Vice President and Chief Technology Officer for Cubic Global Defense; Vice President and Executive Director of the Neuroscience Division at Intific; and a Program Manager for DARPA, where she created and oversaw the Agency’s first performance-oriented neuroscience programs. She is a Director for Gilgamesh Pharmaceuticals, Attune Neurosciences, Paradromics, Cognixion, Morphoceutical, and Dimension Inx, and a Scientific Advisor for Spark Biomedical and Open BCI. She holds a Ph.D. in Neuroscience from the University of Illinois, Urbana-Champaign.
Sanjay N. Misra, MD, MBA
Sanjay N. Misra, MD (Hons), MBA, FACS, FAANS, MAICD is a Physician and Surgeon. He is affiliated with various healthcare organizations with a focus on whole person-centered care and operational logistics for sustainable delivery. Particularly notable, unique areas of expertise are for Ambient AI , Brain-Machine interfaces, Human Machine interfaces, and fit-for-purpose Network Intelligent Learning Systems. Able to successfully guide robust ethical applications for Cognition, Neurogenetics, Neurodevelopment, Non-invasive and Invasive Neuromodulation for Neuropsychiatry, Injury, Stroke, Pain, Human/Veterinary Informatics, Non-Human/Human organ-on-a-chip for cellular/gene therapies, Child's Brain, and Mind-Body Dysfunction Rehabilitation. He has a longstanding membership with the Institute of Company Directors and Law Council of Australia, as well as with the American College of Healthcare Executives, the Food and Drug Law Institute, and he has served on the Medical Advisory Council for Aesculap/B. Braun. He is a Neurosurgeon with complex systems understanding and over 38 years of clinical and scientific experience and greater than 20 years of principled scientific regulatory experience. He holds a M.D. received with Class One Honors, from the University of New South Wales. His experience includes practical experiential knowledge of institutional practices and processes, as well as administrative and ethical elements for future innovation and its evolution, from bench to bedside and beyond.
Clare Padgett, MBA
Clare Padgett, MBA, is a proven Technology, Product Development, and Operations leader with extensive experience in the medical device industry with over 20 years’ experience in leading research and development, product innovation, and portfolio management in medical devices. Her expertise lies in neurological and cardiovascular products. She is currently the Principal and CEO of Luminescent Consulting LLC, which performs strategic consulting and program leadership for early stage and mature medical technology companies. She was previously Vice President of Research and Development, Operations, and Quality for Abilitech Medical and spent 31 years at Medtronic, where she was Senior Director, Therapy Delivery System – Neuromodulation and the Team Leader for Product Development. She holds an M.B.A. from the University of St. Thomas in Minneapolis and is a graduate of Notre Dame.
Katrina Gwinn, MD, FAAN
Dr. Katrina Gwinn's extensive career experience spans regulatory, discovery, clinical, and translational medicine. She has more than 20 years of experience in the fields of neurology, discovery science, clinical trials, NIH grants management, and regulatory science. Her particular clinical expertise is in Parkinson's Disease and Alzheimer's Disease. From a discovery science perspective, gene discovery and clinical trials experience as well as translational medicine are her strengths. Her regulatory experience is in neurological devices, as well as post-market safety.
Currently an independent consultant, she was the Acting Associate Director, Postmarket Programs for the FDA Office of Product Evaluation and Quality (OPEQ) in the Center for Devices and Radiological Health (CDRH). She was previously a Medical Officer and reviewer in the Division of Neurological, Psychiatric and Rehabilitation Devices of CDRH where her role included evaluation of protocol design, endpoints, and analysis for device approval;-ensuring the safety and effectiveness of medical devices; and review of other relevant safety and efficacy data. She also was the Chief Medical Officer (Acting) for FDA's OHT-5 (Neurology, Neurosurgery, Psychiatry, Rehabilitation) Devices, OPEQ-CDRH. Prior to FDA, she was a Program Officer at the National Institute of Neurological Disorders and Stroke (NINDS) where she designed, developed, and managed the NINDS Parkinson’s Disease Biomarkers Program (PDBP). Dr. Gwinn was also previously Vice Chair, Research, at Baylor College of Medicine in the Department of Molecular and Human Genetics, was a Staff Clinician and Head, Parkinson's Disease Unit for the NIH Clinical Center, and an Academic Neurologist at the Mayo Clinic. Dr. Gwinn was a fellow in Parkinson's and related disorders at the Mayo Clinic, did her residency in Neurology at the University of Michigan School of Medicine, and received her MD from the Vanderbilt University School of Medicine.
Rhonda Robinson Beale, MD
Dr. Rhonda Robinson Beale is Senior Vice President and Deputy Chief Medical Officer, Mental Health Services, for the UnitedHealth Group. She is a seasoned healthcare executive with over 30 years of experience in health care systems, managed care, and quality improvement in behavioral health and medical care. Dr. Robinson Beale has served in the past as Senior Vice President, Chief Medical Officer for Blue Cross of Idaho and for several other large national and local health care organizations, such as Optum, PacifiCare, Cigna, Blue Cross Blue Shield of Michigan, and the Health Alliance Plan in Michigan. She has been involved with many national organizations as a subject matter expert, including the National Institutes of Health, National Institute of Mental Health, Institute of Medicine, National Quality Forum, American Psychiatric Association, American Psychological Association, American Society of Addiction Medicine, NQA, and others.
John Donoghue, PhD
John Donoghue is the H.M. Wriston Professor of Neuroscience and Engineering at Brown University. He is known for translational research in human brain computer interfaces to restore movement for people with paralysis (known as ‘BrainGate’, as well as for fundamental research to explain how networks of cortical neurons compute actions from plans. At Brown, he was the founding Chair of the Brown Department of Neuroscience, the founding director of the Brown Institute for Brain Science (now the Carney Institute) and the Department of Veterans Affairs Center of Excellence in Neurorestoration and Neurotechnology. Donoghue was a member of the US BRAIN Initiative’s first NIH Working Group and is a fellow of the National Academy of Medicine, American Academy of Arts and Sciences, as well as several other academies. His awards include the German Zülch Prize (2007), the Roche-Nature Medicine Prize (2010), the Schrödinger Prize (Germany, 2012), and the first Israeli Brain Technology Prize in 2013.