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David Barone, Principal

David BaroneDavid 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

Zvi LadinDr. 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.

 

Michael Imhoff, MD, PhD

Michael ImhoffBoard 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.

 

Andrea Nadai

Andrea NadaiSeasoned 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. 

 

Zohar Zephrani, PhD

Zohar Zephrani

Dr. Zephrani has extensive research background in the fields of neuroscience, cognition, sensory, perception and other. She worked and managed large-scale projects focusing on discoveries that enhance understanding of the neural bases of human behavior projects at major academic and medical centers, including Columbia Medical Center, Cornell University and Brown University. 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.

 

Denise Clarke

Denise Clarke

Over 15 years of experience in clinical research and development of new products in the medical device sector. Prior to BMTA, Denise worked in central research administration for Boston University, overseeing grants, contracts and agreements for a large portfolio of departments. She has also worked in research management roles at Brigham and Women’s Hospital, Harvard Medical School and the VA Boston Healthcare System, and as a Certified Clinical Research Associate (CCRA) at Philips Respironics, designing and overseeing research projects to evaluate new technologies. Denise currently serves on the program committee for the Boston chapter of the Healthcare Businesswomen’s Association (HBA) and is past president of the New England Chapter of the Association of Clinical Research Professionals (ACRP). B.Sc., Social Psychology and Sociology, University of Ulster; MBA Health Sector Management, Boston University.

 

Malavika Raju

Malavika Raju

Background in biochemistry. Prior experience includes drug discovery research, and quality and regulatory affairs positions at biotech and pharmaceutical companies in India and the U.S. Malavika has leadership experience with numerous student organizations at University of California, Los Angeles, including chairperson of the Student Media Board of Directors. B.Sc. Biochemistry, University of California. Los Angeles

 
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