The majority of medical devices get cleared for commercial deployment through the FDA’s 510(k) clearance process, which is the fastest and most economical route to market for a new medical device. ZeroTo510 has developed a unique program that enables entrepreneurs with ideas for innovative medical devices to take advantage of the fast path to market. ZeroTo510 is a first-of-its-kind cohort-based medical device accelerator. Hosted in Memphis, Tennessee, the program leverages key regional strengths in biomedical research and medical device manufacturing to create a unique program.
How It Works
During the first 90-day phase, entrepreneurs go through an intense, mentorship-driven program that includes classroom activity, hands-on exercises and mentorship sessions. The companies spend the bulk of their time on market validation and proofs-of-concept. In return for an equity stake, each participating company will receive a $50,000 investment to work on developing the initial product and business model. At the end of this phase, each team presents its business to investors and the community on Demo Day.
At the end of Phase I, investors will select up to 3 businesses to move forward to the next phase where they will receive an additional $100,000 investment, for an incremental equity stake. During this second phase the companies will take their prototypes through the next phase of development, and will focus on meeting the FDA regulatory requirements for a 510(k) filing.
We've designed the program meticulously, so as to maximize the probability of success for our entrepreneursAllan Daisley, Co-Founder, ZeroTo510
How do you get in?
Get your application in
If your application is selected, we'll schedule an interview with you so we can get to know you and your technology better