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David Montecalvo

David Montecalvo

Chief Executive Officer

David Montecalvo has more than 35 years of experience in the MedTech 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 MedTech 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 in Biomedical Engineering from Case Western Reserve University, in Cleveland, OH, and a Master of Business Administration from the University of St. Thomas, in St. Paul, MN. He is an Advisory Board member of the Boeing Center for Supply Chain Innovation at the Olin Business School of Washington University, in St. Louis, MO. David is also a certified Lean Black Belt and a holder of seven patents. 

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Resources

February 18, 2021

The New EU Medical Device Software Requirements

With the EU’s new medical device software (MDSW) requirements, the guidance related to qualification, classification, clinical evaluation and cybersecurity present challenges for software as a...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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