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.
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 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 the Medical School of the Ruhr-University Bochum, Germany, and currently chairman of the Section Patient Monitoring of the German Association of Biomedical Engineering (DGBMT). He is member of the editorial boards of 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.
Seasoned health care professional with clinical background in physical therapy and clinical teaching. Expertise in clinical study management, reimbursement analysis, and market research. Prior experiences include 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.
Background in biomedical engineering, translational research and business development. Prior experiences include neuroscience research, digital marketing, market analysis, healthcare policy, reimbursement analysis and commercial product marketing. B.Eng., Instrumentation and Control, University of Pune, India; M.Sc., Biomedical Engineering, University of Texas at Arlington; MBA, Strategy & Entrepreneurship, Babson College.