The medical device industry generally has an easier path to success than developers in the pharmaceutical world.
Especially if an invention is external, moving through the clearance process for FDA approval is light years faster than the life cycle of a new drug from idea to market.
Coupled with that is the level of investment needed to bring a product to market: Drugs generally take years and multimillion-dollar investments; some devices can move from concept to sales in just a few years with minimum investment by comparison.
And research for some medical devices often consists of an idea for an improved product.
Vidhan Agrawal, COO and co-founder of Urova Medical Inc., was a student at Johns Hopkins University when he began developing his company’s product as a class project. Urova is developing a minimally invasive, biodegradable implant that will help treat feminine stress urinary incontinence.
Partha Unnava, founder of Better Walk, a company that is developing a crutch that provides support without risk of injuring nerves, got the idea from being on crutches for two years after an ankle injury.
Agrawal and Unnava are alumni of the Zero to 510 device accelerator, which was created by the Memphis Bioworks Foundation. The accelerator provides startup capital as well as mentoring and assistance in bringing products from the development stage to the application for 510(k) clearance from the FDA.
Agrawal says after completing the Zero to 510 program in 2012, his company received another $250,000 in funding from MB Venture Partners and Innova, which has been used to continue research and file patents.
“We’re trying to build an awareness strategy and then trying to figure out where the next round of funding would come from,” Agrawal says.
When Unnava, a bioengineering student from Georgia Tech University, entered Zero to 510, Better Walk had a design but no prototype. He used the funding to help develop the prototype, and anticipates at least five more versions before the final product is completed. Essentially, though, it’s simply an improvement on an ancient product.
“It has been around for 5,000 years without being altered in a major way,” Unnava says.
The company’s path to sales is easier than other Zero to 510 companies, since it doesn’t have to apply for FDA’s 510(k) clearance. But it does have to set up quality systems to track compliance before it can receive FDA’s Class One Exemption and then begin selling the crutch, currently called “Better Walk Crutch.”
“The name may change,” he says.
He anticipates another investment of between $300,000 and $500,000 to help the company become self-sustaining. The product could be brought to market by late 2014.
Agrawal says the development of Urova’s product will continue through at least January 2014 before it can actively seek FDA clearance. And even if the company accomplishes that goal, there’s still more work involved before the product can be brought to market.
“That’s what makes health care a unique startup space,” Agrawal says. “If you enter it, you understand it’s a long haul and you better be up for the challenge.”