Oh, joy. NeuroMetrix's forthcoming app may require FDA approval

quell
Credit: NeuroMetrix

The Food and Drug Administration has said it doesn’t want to get involved with health-related apps. A forthcoming product from NeuroMetrix, the maker of the Quell device, might change that.

When it became apparent that medical and fitness uses would be one of the biggest drivers for wearables, a lot of people groaned. The Food and Drug Administration would have to get involved.

As it turned out, the FDA was doing some groaning of its own about the prospect, and earlier this year, it released draft guidance for low-risk medical devices that essentially said it was taking a hands-off approach. These are general wellness devices, it said of the new class of wearables that measured sleep and exercise and calorie consumption. It wouldn’t be coming after consumers' beloved Fitbits.

Key, though, is the definition of low-risk devices: They aren't invasive; they don't involve lasers or radiation exposure; and they don't raise new usability or bio-compatability issues.

Also key was the FDA's declaration that there is a subset of apps it would be regulating. The FDA calls them mobile medical apps and defines them as apps that are de facto medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.

And so the lines were drawn. The FDA would leave the general-health apps and wearables alone, but regulate what it deemed to be medical device apps. Now, though, as both apps and wearables increase in functionality, it seems as though those lines are set to blur. It didn’t take long at all.

A new approach to pain management

Enter NeuroMetrix. It is a publicly traded company that recently launched Quell, an over-the-counter device that uses electrical nerve stimulation to manage pain.

Quell, briefly, works with the body's sensory nervous system to send neural pulses to the brain, triggering pain relief. The device is calibrated to provide the exact amount of relief needed and to work 24/7 — that is why NeuroMetric designed it to wrap around the calf. Quell also comes with a smartphone app for the users to track their therapy.

While it may sound like something more befitting a late-night television ad, one user — an unpaid user — tells me it works. She describes it as "a pleasant electrical stimulation or vibration that blocks the pain messages from where they are being generated. So when the pain signals get to the spinal cord, it doesn't recognize them as that much pain." You'll hear her story in a moment.

FDA gives its approval for the device

It took two years, but last year NeuroMetrix got FDA clearance for the device — the device, not the app — to be sold without a prescription, after starting out as a prescription-only product.

"It is unusual for an over-the-counter wearable to go the FDA route, but a lot of the things we were trying to do here required FDA approval," Frank McGillin, senior vice president and general manager, tells me.

Quell delivers a therapeutic benefit, he says. "It is possible to provide a medical-related app that makes soft claims about pain without going through the FDA, but we didn’t want to do that."

It was the FDA's approval that caught the attention of some physicians that practice in this area, such as Sid Sharma. "This device definitely works," he tells me. Sharma is an associate of American College of Foot & Ankle Surgeons, practicing in Manhattan's meatpacking district. He said he is not paid by NeuroMetrix to discuss Quell.

The stimulation Quell provides can reduce the pain intensity chronic suffers feel and possible make people less dependent on medication, he says.

Micke Brown, corporate secretary and steering committee chair of the Pain Community, is a case in point.

Brown, who lives in western Maryland and is also, ironically, a pain management nurse, has chronic pain in her feet, knees and hips related to osteoarthritis. "Sometimes I would start limping toward the end of the day because of the discomfort," she tells me. "It was like a hot poker sticking through my heel."

She has been using the unit for two months, and so far, "I have been very impressed. I no longer limp at the end of the day, and it allows me to do a variety of activities that I couldn’t do sometimes on bad days, like gardening or walking."

The app is a great touch, she adds. "It can track when the device is running or due to start again."

A major app upgrade

The company released a major upgrade of the app, McGillin says. It now backs up data the user is collecting about the use. It also is looking at trend data on an anonymous level "to help us improve the results people are getting. We will use this data to optimize the delivery of the therapy."

That is apparently not all the company has planned for its app, or rather its next series of apps as it continues to roll out products.

McGillin would not discuss specifics but did say the company is focusing on using electrical nerve stimulation in "a number of different areas to address more types of pain. We are also looking at sleep — that is an area that is underserved too."

He said NeuroMetrix is working with a university in the Boston area. "We plan to have some new news in 2016 and have other things planned beyond that."

Apps will clearly be part of the mix — and this time, they might require FDA approval as well, he said. "We are in discussions on that with the FDA right now."

It is too soon to say what the final decision will be, although McGillin seems to be prepared, or at least resigned, for any outcome. "As you add more functionality to an app, at some point you start pushing into medical device world."

Like I said, it didn’t take all that long.

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