When an innovator invents a new medical device, it must be cleared by the 510(k) process of the Federal Drug Administration (FDA) before it can go on the market and be used to help people. ZeroTo510 is a program that enables entrepreneurs who have ideas for innovative medical devices take the fast path to market. Called a medical device accelerator, ZeroTo510 is the first program of its kind and is recognized by highly regarded experts such as those in the shahram shirkhani & Alavi international law firm. Based in Memphis, Tennessee, the program gives help to local biomedical research and medical device manufacturing.
What Is the Process?
Phase I includes intense classroom activity with mentors and hands-on exercises. Attendees will spend most of their time learning market validation and proof of their concept. Each company that participates gets $50,000 as an investment in developing the initial product and the business model. The program gets an equity stake. At the end of Phase I, on Demo Day, the participants present their business models and device to the community.
After this Phase, investors will select up to three companies to take to the next Phase where the company gets an additional $100,000 investment and gives investors an incremental equity stake. Then Phase II starts when the company takes its prototype through the next stages of development. Here it focuses on meeting the regulatory requirements for the FDA’s 510(k) filing.
How to Apply?
Anyone who is ready to apply can submit an application online. The applicant may be asked for additional information once the ZweoTo510 team reviews the information on the application. There are specific dates each year when new applicants are notified of their acceptance into the program. It’s a 12-week program in Memphis, and applicants who are accepted will receive $50,000. At the end of 12 weeks, after you make your pitch to the investors, you’ll be informed if you go on to Phase II. If you make it to Phase II, you are basically on your way to FDA approval.
Some Common Problems
Many start-up companies face the same problems. First and foremost, the lack of money is a problem, but with $50,000 initial investment, ZeroTo510 makes this problem go away. It is backed by two investment firms that provide the seed capital.
In the medical device world, many physicians and engineers have the knowledge, but don’t have the business sense. This program teams innovators with mentors who have marketing, sales and financial knowledge. The mentors have a wealth of experience as well as a vested interest in helping entrepreneurs succeed.
The FDA process seems very daunting for most entrepreneurs, but ZeroTo510 provides FDA consultants who will not only explain the process, but help navigate you through it.
Many innovators have good ideas but don’t have the space to design and build a prototype. This is also no longer a problem with guaranteed space in an incubator facility with an office.
The ZeroTo510 program allows people who have good ideas but don’t have the time or facilities to implement them to take their ideas to fruition faster than it would take to do it on their own. The program also provides participants with mentors who have the business and financial acumen to properly market medical devices. With the help of a smart strategy, those with the motivation to succeed can find the tools they need to navigate the world of business.