At a time when the regulatory barriers put up by the Food and Drug Administration seem to be easing a bit, Medtech companies are still facing challenges bringing new products to market, a panel at the Medtech Investing Conference 2015 in Minneapolis said on Wednesday.
The panel discussion, entitled "Getting to Market Quickly: How to Successfully Manage CMS and the FDA," featured a 5-person panel made up of industry experts. They said an important part of bringing products to market is planning ahead, and thinking about reimbursement from the beginning, as opposed to after a new therapy has been developed and/or approved for market.
"I encourage our clients to really get involved in reimbursement early, as a separate function outside of marketing and sales," said Jolayne Devers, principal with JD Lymon Group. "Really understand your landscape first and then be flexible, because things can change."
William Murray, president and CEO of the Medical Device Innovation Consortium, agreed that working with consultants early to get a handle on reimbursement is a good idea. But he also urged companies to think about the patient perspective—since that will be closely tied to insurance coverage. “There is a big push for adding the patient’s voice to the equation,” he said.
The panelists also noted the importance of working early with specialist societies within the American Medical Society, which are instrumental in assigning a therapy its current procedural terminology (CPT) code. Devers said that working with the AMA societies can be "an extremely political process," and said the earlier the process is begun, the easier it is for the device manufacturer.
As with some other panels, the industry insiders praised the FDA’s recent efforts to work collaboratively with medtech companies. “The FDA’s getting more reasonable,” said Mark DuVal, president of DuVal and Associates. “[The agency] is more open to suggestion, rather than trying to dictate what should be done.”
Earl Fender, CEO of Vertiflex, said that the FDA has been working closely with his company on the premarket approval (PMA) process. “It’s been clear that the agency wants to work with the sponsor to make sure the process is efficient,” he said. “I find it quite refreshing.”
But the FDA is not the only player, of course. Devers notes that the level of evidence required by health insurers and the AMA is now greater than what is required by the FDA. "Very often [companies] are shocked at how much evidence they’re going to need in order to get a code," she said. "Understanding the various competing priorities and the value of messaging to each of the stakeholders is a key component in moving your strategy forward."
Dave Amerson, president and CEO of Neotract, says his company started slow and tried to define what success looked like. He said that finding the right sales reps was also crucial for his company.
It’s not enough to have sales reps who are familiar with the area of medicine a company is addressing, he said. They also have to be able to communicate why this new therapy is worth a physician’s time. “You want to bring someone in … who can introduce a disruptive technology,” he said.
He added that it’s important to identify physicians who can become advocates for the technology—even if they are not yet being reimbursed for using it. "As you commercialize, go deep, not wide," he said; "You need to find a surgeon that is willing to work with you … It’s important to set your strategy for a few physicians rather than a lot of physicians."
