How to Get Your Medical Device to Market Quickly
Collaborating with FDA is key, but your sales team also has a role to play.
May 8, 2015
Dan Heilman
Your new medical device is exciting, innovative, and ready for market. How do you get it there?
That was the topic of a panel discussion Wednesday at the Medtech Investing Conference in Minneapolis.
FDA recently approved an accelerated review process and pathway to get critical medical devices to market faster. That means in part that time-consuming trials for premarket data can be avoided more often. But quality clinical data results must still be presented, so it’s key to have your strategy mapped out in full before beginning the regulatory process.
“Begin with the end in mind,” said Jolayne Devers, principal with the J.D. Lymon Group. “Be flexible and get involved with reimbursement early.”
With that in mind, Mark DuVal, president of DuVal and Associates, advised starting with an intended-use statement for your device. Earl R. Fender, CEO of Vertiflex, stressed starting a device’s premarket approval process as soon as possible.
It’s also important to navigate the FDA process as it suits your product and to develop a strategy for obtaining reimbursement.
William B. Murray, CEO of the Medical Device Innovation Consortium, said that although it might seem to be an imposing entity, FDA really does want to help—and the agency’s reputation has grown more positive of late.
“They want to understand you and your product,” Murray said. “They have high evidentiary standards, but they can also offer expert guidance on clinical trials. Don’t be afraid to pick up the phone and call Rob Califf.”
Dave Amerson, president and CEO of Neotract, said his company had been in dialogue with FDA for some time about a product it’s making.