Medical Device Accelerator Program Launches in Memphis

Navigating the waters of medical device product approval can be challenging to say the least. Even for experienced industry professionals and established medical device companies. But the challenge can be that much steeper for first-timers, entrepreneurs with an idea, but perhaps not as much experience.

A new program from the Memphis Bioworks Foundation in Tennessee recently has been launched to give some of these nascent companies and device ideas the tools to run the U.S. Food and Drug Administration gauntlet. Applications are now open for a program called “ZeroTo510,” which is designed to help entrepreneurs bring medical device products and companies to market, and are being accepted now through April 5.

ZeroTo510 is a unique, entrepreneurial accelerator program that focuses on leveraging the regional strength of the Memphis area in medical device research and manufacturing, according to program organizers. The goal of ZeroTo510 is to help medical device entrepreneurs navigate the startup process, refine business models and—as the program’s name implies—achieve the FDA’s 510(k) pre-market notification filing.

Through a competitive application process, six companies will be selected to participate in an intensive, mentor-driven, 12-week program of instruction and hands-on activities. In addition, each company chosen for the program will receive $50,000 in seed capital from Innova, a pre-seed, seed and early-stage investor founded by Memphis Bioworks in 2007 and focused on starting and funding high-growth companies in healthcare and technology in Tennessee. The seed capital also is funded in part by MB Venture Partners, a Memphis-based venture capital firm that provides equity capital and strategic direction to life-science startups.

The program is launched by Memphis Bioworks Foundation, a not-for-profit organization that leads collaboration among public, private, academic, and government entities to accelerate the growth of the bioscience industry in the Memphis region, and Innova. ZeroTo510 is an initiative of the Greater Memphis Accelerator Consortium, a Startup TN affiliate program funded by the State of Tennessee Economic and Community Development Commission.

“ZeroTo510 is the first-ever program of its kind in the United States focused on medical devices,” said Allan Daisley, director of innovation and sustainability initiatives for Memphis Bioworks. “An entrepreneurship program for medical devices is an ideal match for the resources and talents of the Memphis area. Typically, it can take years for ideas to pass through regulatory hurdles. An accelerator program that focuses on the 510(k) filing is the right approach to achieving an expedited path to market, but achieving success in that path requires unique skills and knowledge. ZeroTo510 will provide that.”

At the end of the 12-week program, the participants will pitch to a group of investors. The investors will select up to three finalists, who will receive as much as $100,000 in additional capital infusion and the opportunity to further develop their business and then present at the 10th Musculoskeletal New Ventures Conference in Memphis in October.

Competition for participation in the program is open internationally. However, companies selected must be Memphis-based or willing to relocate to Memphis for participation.

“Those who are already Memphis-based know the resources and talent available to them here,” said Ken Woody, Innova partner and ZeroTo510 board member. “Those who relocate here will soon learn that Memphis is the right environment to launch and grow a medical device company, and we expect them to quickly develop connections here.”

Applications to participate in ZeroTo510 are due by April 5. Companies for participation will be notified by April 12. The program will begin on May 12. Information on applying and additional information about the ZeroTo510 program is available at www.zeroto510.com.