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.
Charles Carignan, MD
Charles Carignan, MD is focused on breakthrough medical product development and market access, has over 30 years’ experience leading medical technology corporations, and is currently a director for three companies – Biothea Pharma, SamanTree Medical (where he is Executive Chairman), and Neurofenix. He was previously CEO of SoniVie, BionX Medical Technologies, and NinePoint Medical, and was Chief Medical Officer at Boston Scientific. He has served on committees for the U.S. Food and Drug Administration, Centers for Medicare & Medicaid Services, the World Health Organization, the United Nations, and the U.S. Agency for International Development. Dr. Carignan earned his undergraduate degree from Yale University, received his M.D. degree from the College of Physicians and Surgeons of Columbia University and trained in general surgery at Columbia-Presbyterian Medical Center.
Amy Kruse, PhD
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 Misra, MD, MBA
Sanjay Misra, MD, MBA, FACS, FAANS, MAICD is a Medical Officer at the FDA Center for Devices and Radiological Health and a member of the Clinical Medical Staff for Covenant Health at Fort Sanders Medical Center in Knoxville, Tennessee with a focus on spinal trauma, management of concussion and traumatic head injury, and management of pain and non-invasive neuromodulation for PTSD, depression, cognition, and post-stroke rehabilitation. He is a member of the American College of Healthcare Executives, the Food and Drug Law Institute, and has served on the Medical Advisory Council for Aesculap/B. Braun. He is a neurosurgeon with over 37 years of clinical experience and 13 years of FDA experience. He holds an M.D. from the University of New South Wales and an M.B.A. from Karnataka State University in India.
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.