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.

“We ended up meeting with the agency face-to-face and walked through the process,” Amerson said. “For a small company like ours, it was about getting to market sooner and iterating the technology quicker. We ended up getting approved in six months and a week, which was very favorable.”

If your technology is at all novel, it can be especially crucial to get it in front of FDA, according to DuVal. “You might have to argue that the product is a predicate, but it’s the most collaborative time you’ll have with the agency,” he said.

Another key factor in getting to market: Educating and inspiring your sales force.

“Some reps are extremely good at moving market share,” said moderator Paul Buckman, president and CEO of Conventus Orthopaedics. “But the ones who are capable of changing practice are rare.”

Amerson said he once made the mistake of bringing in urology experts to sell a product in that area. He learned that it’s more important to have reps who are experts in things like reimbursement coverage and CPT codes.

“The efficacy of our product depends on how well it’s reimbursed,” Amerson said. “You can have the greatest technology in the world, but if hospitals and surgeons aren’t getting paid for it, it’s hard to move the ball forward.”

Dan Heilman is a freelance contributor to MD+DI.

[image courtesy of COOLDESIGN/FREEDIGITALPHOTOS.NET]