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Leah Amir

Leah Amir

Clinical & Technical Advisory

 

Over 20 years of success commercializing new products delivering clinical solutions leading to improved patient outcomes in the areas of diagnostics and therapeutic in cardiovascular disease, orthopedics, gynecology, oncology, neurology and tissue regeneration.  She has developed a stellar team of seasoned experts.

Clients include Mallinckrodt Medical, Boston Scientific, Zimmer, Lab Corp, Molecular Diagnostics, Medtronic, Biosphere Medical, Radiotherapeutics, Omnisonics, Laserscope,  Osteotech,  Veran  Medical  Technologies,  Merit Medical,  OrthoSensor,  Mobius  Therapeutics,  Sharecare  Healthways, MolecuLight  and others.  She leads a team of highly qualified specialists in science, regulatory, clinical trials management, and healthcare finance.  She has published extensively on health economics of medical interventions, trained sales teams on consultative selling and presented to numerous hospital value added committees.

Leveraging IT expertise from VantageLinks, LLC a WBE and the research arm -The Institute for Quality Resource Management (IQRM)- our customers gain turn key solutions aiding product development, testing by medical professionals, software development, statistical analysis all brought together to meet the expectation of the FDA and payers.

Armed with a Master of Science and Master of Healthcare Administration from Washington University School of Medicine coupled with over 20 years of success she is delivering knowledge of science, quality control, manufacturing for USP and FDA products aiding her clients regulatory process. As the manager of quality control at Mallinckrodt Medical she had clearance from the FBI and DEA to conduct microbial testing of all in process and finished narcotics and products containing controlled substances. In addition, she was responsible for the microbial and contaminate testing of the manufacturing environment and the water used in various manufacturing environments.  She did pyrogen testing for medical products sold to Germany complying with the strictest manufacturing specifications.

Post graduate education received at Wharton Leonard Davis Institute cost effectiveness/outcomes analysis, and Harvard Patient Safety from the Institute for Healthcare Improvement with honors support her skills to create and use methods to collect information, validate improved clinical outcomes, economic metrics, and relate this information in support of regulatory success including coding and payment. She is an active participant in the Healthcare Financial Management Association (HFMA), American College of Healthcare  Executives  (ACHE),  Wound  Healing  Society  (WHS),  American  Heart  Association (AHA) a member of the Advisory Board for Boston Med Tech Transfer, on the editorial board of Today’s Wound Clinic, and a mentor at the Center for Emerging Technologies in St. Louis, MO.