Photo Credit: Paul Savage Photography

By Padma Nagappan

One of the panels at the recently concluded WLSA Convergence Summit in San Diego focused on how things have changed within the last five years and whether the guidelines the FDA issued last year for devices helps provide clarity in navigating the choppy waters of clearance.

The panel featured two companies that have received 510(k) clearances, Sotera Wireless and DexCom, as well as Beth Seidenberg from Kleiner Perkins Caufield & Byer and Dane Stout, executive director of connected health and biomedical practice at the Anson Group.

Moderator Frank Rahmani, a partner at Cooley LLP, asked panelists for their perspective as innovators and investors about regulatory changes, strategy to handle the approval process and priorities in choosing investment areas.

Sotera Wireless recently announced it had approval for its ViSi Monitoring System from the FDA and the CE Mark in Europe. ViSi is a vital signs monitor that can be worn on the wrist and allows patients to remain ambulatory instead of being tethered to a hospital bed. An upcoming version will be able to transmit the vital signs to care givers wirelessly.

CEO Tom Watlington said the guidelines issued by the FDA last fall help provide clarity and remove confusion, and they helped the company on its path to its first approval. Having been in healthcare for 30 years, he thinks things have changed substantially in the last few years.

"We did have to calibrate to new changes, but now there's emphasis on the human factor.  Fortunately we had invested time and effort in preparing for it. The other thing, there's small gaps in filing and we found they were parsing a lot of the filing to internal consultants -- so the questions are more numerous, more specific, more detailed, but fortunately we were on point," Watlington said. "Things are clearing up. None of these are obstacles. Going forward will be easier for us, but the first FDA approval was a new experience."

DexCom, the developer of the Seven Plus continuous glucose monitoring system with an under skin implantable sensor, transmitter and receiver, has navigated FDA approval successfully in the past, for different versions of its products. CTO Jorge Valdes said last year's guidelines make it clear what's covered and what's not and it kept the smartphone out of the regulatory environment, which is good.

"I spent 20 years in a regulated environment, first in telecom and now in healthcare. It is different now. I would say we have a good relationship with the FDA. The secret to that is to communicate and do it often," Valdes said. "Today devices are very much integrated, so the FDA recognizes the advantage of integrating with smartphones. They want to see your risk analysis, your clinical protocols and where you want to do the trial. When I first started, there wasn't even a human factor filing. With smartphone apps ramping up, this human factor filing will become very important."

Stout with the Anson Group said the FDA did act quickly in issuing the new guidelines and its goal is to focus on intended usage rather than the actual technology.

Rahmani asked Seidenberg if she agreed with them that the new guidelines are helpful.

"Most definitely. The key areas we emphasized with the FDA through numerous meetings are the importance of clarity and predictability, both from a regulatory perspective and how reviewers react. The senior officials are well aware of that and are taking a very proactive approach in drawing the line," Seidenberg said.

When it comes to prioritizing investments when presented with an array of investment opportunities, she said the top priority is whether a start-up has an innovation and second, whether it fits the practice of care or improves it.

Asked what had changed in their thinking since three years ago, Watlington said the main point for a start-up is not to have an incremental innovation, but a disruptive innovation.

"So it's important to have a well thought out strategy in how you're going to present to the FDA. In our case, we decided to sequence our filing because it was very complicated, so we phased it, step-by-step. There's value in doing this methodically, get something cleared and get it out there, then do the next thing."

Valdes said DexCom's class III device puts it at the highest category of regulation. "So we're filing products, we're filing changes on top of the products, then we're filing products with partners on the side. So getting it to the FDA in a way that makes sense is key."

Watlington emphasized that if some one seeks an open-ended device, they are guaranteed not to like the process, that he's made this mistake himself in the past. Stout stressed that regulation strategy has to be methodical; it's not like speaking at a conference and giving them a big picture view.

"Things are changing, winds are moving in the right direction, positive direction now," Seidenberg said, pointing out how there used to be a huge backlog with the Center for Devices and Radiological Health (CDRH). "There was no ability to hold the FDA accountable as they were on the drug and biologic side. Entrepreneurs are very smart, so they began to focus on CE mark to get their products out there. That is not what we want. A lot of this is funded with NIH funding and we want it in the U.S. market. We're starting to see things improve."