About Us

 

Management
Raleigh NC, Sapheon, Inc. - Sapheon is a medical device development company that develops new approaches and disruptive technologies for the treatment of vascular disease. The company’s current focus is the VenaSeal Sapheon Closure System that uses a proprietary medical adhesive to close the saphenous vein, eliminating the need for surgery, ablation, anesthesia, or the use of harsh chemicals. Sapheon is actively preparing for U.S. clinical trials and FDA approval of the VenaSeal Sapheon Closure System. Photography by Griffin Hart Davis of exumphoto

Integral Medical Device Consulting, LLC is led by Bruce Choi, a seasoned medical device professional with broad experience in Quality, Research and Development, Operations, and Global Supply Chain at large multi-national companies as well as privately held start-up ventures. With over 20 years of industry experience, Bruce brings exceptional leadership ability and a successful track record of building organizational cultures rooted in integrity and a drive for success.

Prior to founding Integral, Bruce served as a part of the senior leadership staff in Medtronic’s Aortic/Peripheral Vascular (APV) and Coronary Global Operations organization. In this role, Bruce was responsible for the operations of the endoVenous business as well as the APV contract manufacturing footprint, accounting for over $300 million in revenue. Accountable for the quality, availability, and costing of products, internally developed and acquired, Bruce also served on diligence committees giving him a unique perspective on how large companies systematically identify gaps and value the assets of acquisition targets.

Bruce’s career also includes experiences with several start-up companies, most recently with Sapheon, Inc. which was acquired by Covidien for $238 million. Originally joining the company as its Vice President of Quality, he led the company through its first in man studies, ISO-13485 certification, and the CE marking of its flagship product, the VenaSeal Closure System. Expanding on the company’s early successes, Bruce moved to the roles of Vice President of R&D and Operations where he developed configurations of its product for European commercialization and its IDE study supporting a PMA approval by the FDA. Concurrently, Bruce represented the company’s Development and Operations functions through due diligence activities with multiple suitors. With an appreciation for compliance and scalability, the systems that Bruce developed and implemented were free of 483 findings during FDA site inspections and were leveraged by Medtronic for multiple years to support global commercialization.

With a B.S. degree in Material Science & Engineering from Cornell University and a M.S. degree in Biomedical Engineering from Cal Poly, Bruce is highly technical and able to communicate at all levels of an organization. In his career, he has worked on a diversity of products, including single use disposable products to active implantable pulse generators.