Medical device consulting expertise; David Barone; Zvi Ladin; Michael Imhoff; Yossi Elaz

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Principals

David Barone, Principal

David Barone's background consists of 25 years experience in the healthcare and medical industry in the US, including general, technical and operations management, strategic planning, marketing and business development. David Barone held senior management positions in a number of medical device companies, overseeing product development, marketing, pilot manufacturing, clinical evaluations, regulatory affairs and intellectual properties. In addition, David Barone is an accomplished entrepreneur, founding, financing and growing several healthcare service organizations. While leading these companies, David Barone entered into clinical and business affiliations with many top-tier medical centers in the US, negotiated and successfully contracted with many of the national and regional health plans, and evolved high quality and efficient clinical delivery systems. David Barone has consulted and assisted US and off-shore medical technology organizations, ranging from start-ups to Fortune 500 companies, in diverse areas including market development, opportunity analysis, regulatory and reimbursement strategies, business development, financing and more. B.Sc., Electrical Engineering, Technion, Israel Institute of Technology, M.Sc., Bio-Medical Engineering and Master, Business Administration, both from Rensselaer Polytechnic Institute, NY.

Zvi Ladin, PhD, Principal

Dr. Ladin has over 20 years of management experience in the medical industry, government and academia, focusing on clinical applications, regulatory affairs and reimbursement strategies. 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 scientific 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 Science and Technology.

Yossi Elaz

Background includes senior executive management positions in large global medical device organizations, including Siemens Medical Systems, and most recently, a member of Draeger Medical’s Global Management Team. Yossi Elaz experience includes overseeing large R&D organizations, Product Requirements management, Product Life Cycle Engineering, Operations management and Business Development activities, all in compliance with US and International quality systems and other regulations. Yossi’s areas of expertise include platforms for patient monitoring system, therapy devices and critical care information management systems. Over the years, Yossi has developed large number of clinical partnerships with many leading medical institutions and opinion leaders and has been involved in the evaluation of numerous medical device technologies. B.Sc., Electrical Engineering, Technion, Israel Institute of Technology

Michael Imhoff, MD, PhD

Board certified in surgery and intensive care medicine, with 18 years of clinical experience in large medical centers and 16 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 lecturer in Medical Informatics, a member of the editorial boards of the Journal of Critical Care and of Care of the Critically Ill and a reviewer for several international journals. Medical school: University of Bochum and Munster, Germany; PhD, Ruhr University, Bochum, Germany. 1991 Recipient of the Lederle Prize for Research.

Dr. Imhoff is the managing director of Boston MedTech Advisors Europe GmbH with office in Dortmund, Germany.

Tom Keegan

An accomplished marketing professional with over 20 years of marketing, technical and clinical experience in the medical industry, Tom held senior management positions in private and public companies, including Haemonetics, UltraCision, Johnson & Johnson Ethicon Endo-Surgery, Smith & Nephew Endoscopy, Endius, and most recently, serving as the Vice President of Marketing for MIS (Minimally Invasive Surgery) Solutions for Zimmer Spine. Tom's experiences include development and implementation of marketing plans, market research and analysis, professional education, marketing communications, pricing strategy and reimbursement development. Tom has been responsible for key areas during the acquisitions and mergers of early stage companies into major corporations, overseeing the integration of sales forces, technology transition and personnel training. Education: Studies in the BA, Marketing and BET, Electrical Engineering Programs at Northeastern University Boston, MA.

Andrea Nadai

Seasoned health care professional with clinical background in physical therapy and clinical teaching. Prior experiences include the development of corporate compliance program, risk management, grant writing, searching state and federal regulations and supporting accreditations. Managed clinical support services in sponsored clinical studies, managed rehabilitation clinic operations, including physical, occupational and speech therapists, and provided direct care of patients with neurologic and orthopedic disorders in outpatient, inpatient and home-based settings. Led continuing education seminars in diverse areas, including pediatrics, gait analysis, manual therapy techniques, and more. B.Sc., Physical Therapy, State University of New York, and Master, Health Professions, Northeastern University, MA.