•Proven ability to take a vast range of innovative medical product types from concept to commercialization.
•Skilled in directing the development of internal and external programs to further expand platform technologies, minimally invasive techniques, early intervention, and emerging therapies within the medical arena.
•Provide technical leadership and inspiration to individuals and teams comprised of junior and senior level employees.
•Highly experienced in developing product portfolio strategies, pipeline execution, timely achievement of program milestones, and critical launches.
•Experienced in drafting and maintaining a complete invention disclosure portfolio for patents and communication with internal and external patent counsel.
•Leverage medical insight that accelerates innovation, value and safety for patients and customers everywhere through strong leadership and partnership with the innovation and business partners: Global Strategic Marketing, Medical Affairs, New Business Development, Regulatory, Clinical, Quality, & Supply Chain.
•Led the implementation of Lean Manufacturing, Continuous Flow, and Design For Manufacturability (DFM) processes. Responsible for the planning and budgeting of product and process improvements/cost reduction initiatives in high volume manufacturing settings.
•Knowledge of the due diligence and business development process with regard to licenses, mergers, and acquisitions.
•Active knowledge of regulatory standards, design controls, and associated documentation as they apply to Investigational Device Exemptions (IDE), Food and Drug Administration (FDA), CE mark, 510(k), Premarket approval (PMA), Technical Filing, Design Dossiers, ISO-13485, ISO-9001, and Shonin submissions.

by

Brian J. Bergeron

2609 West 49th Street

P: 1 512-906-0808

F: 1 512-381-7076

Brian J. Bergeron is IAD member since 2016, with 2019 IAD rating.