Applicants have a Duke Affiliation which satisfies one of the following requirements:
Duke Staff (Post-docs, Residents and Fellows)
Additionally, submission ideas and devices must be classified as a Class I or Class II medical device by the FDA
The FastTrack team reviews and scores applications using several factors, including readiness and motivation of the inventor/team, capability match with the FastTrack program, market validation of the idea, a need evaluation and intellectual property and competition assessments.
The FastTrack consult form aims to capture early stage ideas and guide the founder to think critically in respect to how their device addresses an unmet need, what procedures currently exist as potential competition and the scope of this issue beyond Duke.
Be prepared to answer questions regarding:
A description of your proposed research project
The clinical need your idea meets including current technologies, devices or tools that are currently used and why they are insufficient.
An estimated market size of this device at Duke and across the United States
The potential design of your device, and if possible, going into detail on the materials, software and components it may include
Any questions you think the FastTrack team and Innovation Committees should focus on during their evaluations
Medical device translation can be complicated, so we made our consult process simple. Here's how to get started: