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Study Design Services

Team

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

Dr. Ladin oversees all Boston MedTech CRO activities.  He has over 25 years of management experience in the medical industry, government and academia, focusing on clinical applications, regulatory affairs and reimbursement strategies.  During that time Dr. Ladin has led a variety of medical device clinical trials, including high risk, innovative medical technologies, such as the artificial heart.  His 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.  Dr. Ladin represented companies in negotiations with the FDA, European and Asian regulatory agencies, and served for five years as a Science Advisor to the Food and Drug Administration.  Dr. Ladin, a recipient of the Whitaker Fellowship and International Research Awards, taught mechanical and biomedical engineering at MIT and Boston University. B.Sc., Aeronautical Engineering and M.Sc., Biomedical Engineering, both from the Technion, Israel Institute of Technology; Ph.D., Medical Engineering, MIT-Harvard Medical School / Division of Health Sciences and Technology.

David Barone

David Barone has over 30 years experience including general, technical and operations management, 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 Boston MedTech Advisors, David held senior management positions in a number of medical device companies and has founded, financed and developed a number of healthcare companies. B.Sc., Electrical Engineering, Technion, Israel Institute of Technology, M.Sc., Bio-Medical Engineering and Master, Business Administration, both from Rensselaer Polytechnic Institute, NY. 

Michael Imhoff, MD, PhD

Dr. Imhoff is a Senior Advisor at Boston MedTech Advisors. He is board certified in surgery and intensive care medicine, with over 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, past board member of the German Association of Biomedical Engineering (DGBMT), and former chair of the Section Patient Monitoring. He is also Clinical 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. Medical school: University of Bochum and Munster, Germany; PhD, Ruhr University, Bochum, Germany. 1991 Recipient of the Lederle Prize for Research.

Andrea Nadai

Andrea Nadai is the Director of Operations for Boston MedTech CRO Group. She is a Clinical Trial Monitor and a seasoned health care professional with expertise in clinical study operations, reimbursement analysis and market research. She is a licensed physical therapist and instructor of continuing education programs. Andrea is responsible for working directly with sponsors and study sites through all phases of the clinical trial.  Prior experiences include the development of corporate compliance program, risk management, grant writing, searching state and federal regulations and supporting accreditations. 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. B.Sc., Physical Therapy, State University of New York, and Master, Health Professions, Northeastern University.