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Boston | Israel | Germany

Study Design Services


Boston MedTech CRO is managed by a team of professionals with a wealth of experience in clinical study planning and execution, as well as broad expertise and experience in all activities supported by clinical evidence, including regulatory, marketing and reimbursement.

Zvi Ladin, PhD

Oversees all Boston MedTech CRO activities. Dr. Ladin has over 35 years of management experience in the medical industry, government and academia, focusing on clinical applications, regulatory affairs and reimbursement initiatives. During that time he has led a variety of medical device clinical trials, including high risk, innovative medical technologies, such as the artificial heart. Dr. Ladin’s experience includes establishing reimbursement and regulatory strategies for therapeutic and diagnostic medical device companies, submission of regulatory applications, including 510(k) and PMAs for products in Class I-III and drug-device combination products. He represented companies in negotiations with the FDA, European and Asian regulatory agencies, and served for five years as a scientific advisor to the FDA. Dr. Ladin, a recipient of the Whitaker Fellowship and International Research Awards, taught mechanical and biomedical engineering at MIT and Boston University.

Ph.D., Medical Engineering, MIT-Harvard Medical School Division of Health Sciences and Technology, MA

David Barone

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.

Michael Imhoff, MD, PhD

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. Dr. Imhoff 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.

Andrea Nadai

Director for Boston MedTech CRO Group. Clinical trial monitor and seasoned health care professional with expertise in clinical trial management, market research and reimbursement analysis. Andrea is responsible for working directly with sponsors and study sites through all phases of the clinical trial. She also manages global operations for BMTA. Prior experiences include the development of corporate compliance program, risk management, grant writing, searching state and federal regulations, supporting accreditations and clinical teaching. As a licensed physical therapist, Andrea has overseen 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.