David Montecalvo

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Wherever you are in your product development lifecycle,
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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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Resources

November 17, 2021

Strategies for Navigating Medical Device FDA and CE Approval

At Sterling, some of the most common questions we get are related to medical device Food and Drug Administration (FDA) approval in the U.S. and the Conformite Europeenne (CE) mark in the European...

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.

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

David Montecalvo