Founder + Principal
Current• Develops and executes business-minded regulatory strategies related to U.S. Food and Drug Administration (FDA) marketing authorization for medical devices and other life science products, including those in the fields of health information technology, physical rehabilitation, wound care, neurology, metabolic disease, vascular medicine, orthopedics, women's health, and digital health.• Assists medical device companies and entrepreneurs in assessing potential regulatory pathways for pioneering medical devices and determining the most efficient and advantageous positioning for new products to meet and exceed FDA regulatory requirements. • Guides the strategy and development of communications with and submissions to the FDA on behalf of clients, including Pre-Submission (Pre-Sub) meeting requests, Breakthrough Device Designation (BDD) requests, investigational device exemption (IDE) applications, 510(k) premarket notification submissions, premarket approval (PMA) applications, requests for designation (RFD), quality systems inspection support, and submission of comments to the docket for new proposed rules or guidance documents.• Utilizes in-depth knowledge of science, regulatory affairs, business planning, and product management background to develop product development plans (e.g., pre-clinical and clinical evidence development) and obtain FDA buy-in to reduce regulatory risk and expedite the product commercialization pathway.• Current President of SCBio Foundation and former member of SCBIO Board of Directors (Executive Committee; Annual Conference Co-Chair)
