Over 35 years experience including management, technical and operations, strategic planning, marketing and business development. Current activities focus on advising and assisting US and off-shore medical technology organizations, ranging from start-ups to Fortune 500 companies, in areas ranging from opportunity analysis, marketing strategy and market development, reimbursement strategies, business development and financing. Prior to co-founding BMTA, David held senior management positions in a number of medical device companies and has founded, financed and developed a number of healthcare companies.
M.Sc., Bio-Medical Engineering and M.B.A., Rensselaer Polytechnic Institute, NY.
Over 35 years of experience in the medical industry, government and academia, focusing on developing and managing clinical, regulatory affairs and reimbursement initiatives. A co-founder of BMTA, focusing on establishing regulatory strategies for therapeutic and diagnostic technologies, submission of regulatory applications, including 510(k) and PMAs for products in Class I-III and drug-device combination products and representing companies in negotiations with the FDA and other regulatory agencies. Zvi taught mechanical and biomedical engineering at MIT and Boston University and served as a scientific advisor to the FDA.
Ph.D., Medical Engineering, MIT-Harvard Medical School Division of Health Science and Technology, MA.
Board certified in surgery and intensive care medicine, with 18 years of clinical experience in large medical centers and 20 years of strategic consulting for leading companies in the global medical technology markets, as well as start-ups in the US and Europe, focusing on technologies and clinical applications for the ICU, CCU, OR and ED. Research areas include trauma surgery, intensive care medicine, patient monitoring, clinical data management, artificial intelligence in medicine and health economics, leading to over 300 publications and scientific presentations. Michael is a professor in Medical Informatics and Statistics at Ruhr-University Bochum, Germany, chairman of the section for patient monitoring of the German Association of Biomedical Engineering (DGBMT), and editorial board member and reviewer for several international biomedical journals. He is also Medical Director of the qtec group, Lübeck, Germany, where he leads a team of scientists and medical writers responsible for clinical evaluations of medical devices according to EU MDR, and design and planning of pre-clinical and clinical studies for regulatory approval.
M.D., Universities of Bochum and Munster, Germany; Ph.D., Ruhr-University, Bochum, Germany.
Seasoned health care professional with expertise in market research, reimbursement analysis and clinical trial management. Andrea analyzes the health economic and reimbursement landscape to assist clients in pursuing the optimal path for market introduction of new products. She also manages global operations for BMTA. Andrea is a licensed physical therapist and clinical trial monitor. Prior experiences include the development of corporate compliance program, risk management, grant writing, searching state and federal regulations, supporting accreditations and clinical teaching. Oversaw support services in sponsored clinical studies, managed rehabilitation clinic therapy operations and provided care to patients with neurologic and orthopedic disorders in outpatient, inpatient and home-based settings.
M.H.P., Health Professions, Northeastern University, MA.
Zohar has extensive research background in the fields of neuroscience, cognitive science, sensation and perception. She worked and managed large-scale projects at major academic and medical centers. Zohar works closely with the client’s executive team to formulate efficient regulatory strategies, in line with business objectives and reimbursement needs, and co-manages regulatory projects with the company’s cross-functional team. She capitalizes on rigorous scientific training to analyze clinical data and published evidence for the determination of clinical and regulatory strategies that lead to obtaining timely approvals. Notable experience with wearable devices, Artificial Intelligence/ Machine Learning based applications, Software as a Medical Device (SaMD), surgical robotics/ navigation, imaging and diagnostic devices. Zohar’s prior experiences also include work in the biotech industry, teaching, as well as leading and managing research teams using advanced imaging technology.
Ph.D., Psychology, Brown University, RI.
Completed Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals.