SAN JOSE, Calif. — The product Steve Archer started work on 14 years ago is just about to hit the market -- he hopes.
The NeuroPace RNS is the first implant to listen to brain waves and autonomously decide when to apply a therapy to prevent an epileptic seizure. It was developed by a company with a staff of less than 90 people, only about 30 on the core electronic, mechanical, and software engineering teams.
Maintaining a lean staff was a conscious decision of managers who have raised $215 million to date and knew the project would take a long time to pass regulatory approvals. "The joke is we have been two years away from an FDA clearance for about a decade," said Archer.
The FDA now says the company is very close to getting a green light, though it is not giving any specific dates. Indeed, an FDA representative was calling the company despite the recent government shutdown to work out details.
"There are a lot of really sexy engineering fields out there that let you make a lot of money, but the medical sector is very regulated so what takes a few weeks to design in a hard drive takes years in medical," Archer said.
On the other hand, "there's a certain feeling when something you personally designed is walking around inside a great number of people -- you feel like it sure better work, but it's more than that," Archer said, recalling some of the 256 epilepsy patients so far who have been able to lead more normal lives due to receiving the implant in clinical trials.
Archer shows a prototype RNS implant in a skull.
The work holds promise of advancing brain science, too. For instance, NeuroPace already has discovered patients can have hundreds to thousands of pre-seizure events every day.
"No one else is recording ambulatory brain wave activities from epileptic patients to the extent we are," Archer said. "We have the world's largest library of such recordings and that's a tremendous resource for all sorts of research -- the opportunity is huge," he said.
Indeed, some say today's deep brain implants are in a stage of development similar to cardiac devices in the early 1980s. They may spawn families of systems addressing a wide variety of neurological disorders.