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David Montecalvo

David Montecalvo

Chief Executive Officer

David Montecalvo has more than 35 years of experience in the Med Tech industry, including executive level positions at Medtronic and, most recently, West Pharmaceutical Services as Chief Operations and Supply Chain Officer.  While at Medtronic, David served as Vice President, Contract Manufacturing Operations, for the company’s Restorative Therapies Group, Vice President, Business Operations Integration, where he was responsible for leading the largest global operations integration in Med Tech history of Covidien plc into Medtronic, and Vice President, Product Development and Operations for Medtronic’s Cardiovascular Cardiac Surgery and Structural Heart businesses. Prior thereto, he held executive operations and research and development roles at Urologix, Inc. and LecTec Corporation.  David earned a Bachelor of Science degree in Biomedical Engineering from Case Western Reserve University, Cleveland, Ohio and an MBA from the University of St. Thomas, St. Paul, MN. He is an Advisory Board member to the Boeing Center for Supply Chain Innovation at the Olin Business School of Washington University, St. Louis, Missouri.  David is also a certified Lean Black Belt and a holder of 7 patents. 

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medical device approval process

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Strategies for Navigating Medical Device FDA and CE Approval

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