Commercialization Associate Intern
Current
Columbus, Ohio Metropolitan Area
HDO Health is a medical device portfolio company dedicated to bringing life-saving technologies to the world. The first medical device in development is a junctional tourniquet that innovates upon designs currently on the market to achieve faster and more efficacious hemorrhage control. HDO Health strives to be Heart-led, Data-driven, and Outcomes-focused in all that we do. As a Commercialization Associate Intern at HDO Health, my primary responsibility has been the development of the Design History File in preparation of FDA 510(k) submission. Specifically, I have drafted our Traceability Matrix, Hazard Analysis, FMEAs, and Usability Plan, and more. I have also helped plan and coordinate formative, summative, and perfused cadaver testing prior to 510(k) submission. Alongside our market research consultant, I conducted a market analysis of competitor medical devices and developed survey materials for more data collection. I have had the opportunity to partner with technical co-founders and external design, testing, validation, manufacturing, and distribution partners to finalize medical product design and have participated in poster presentation and networking events.