Full Name
Trena Depel
Job Title
Vice President of Regulatory, Clinical, Quality
Company
Teal Health
Speaker Bio
Trena Depel has a career spanning over 30 years in medtech development, navigating FDA and international approvals for novel technologies and first-in-class medical devices. Trena has designed and executed clinical trials to support approval and market adoption and navigated products through the PMA, 510k, and De Novo market pathways. She has secured 2 FDA Breakthrough designations for her products in the last 5 years. Trena authored multiple chapters of the 1st edition textbook Biodesign: The Process of Innovating Medical Technologies published by Cambridge University Press and has contributed to over 20 peer-reviewed, publications based upon research she oversaw. Her favorite health domain is women’s health and she is thrilled to support Teal Health’s mission to empower women with the tools, access and resources to make their own informed health decisions. Trena navigated an FDA De Novo Authorization for the Teal Wand, the first and only at-home self-collection device for cervical cancer screening, which targets many key barriers preventing 25% of US women from screening for cervical cancer - a preventable cancer which kills nearly 5000 women a year. Trena holds an undergraduate degree from Indiana University and a graduate degree from the Stanford University School of Business.
Trena Depel