The wearables of the future won't be found on the wrists of personal trainers and spin instructors to track heart rate and tell you when you need a snack. They'll be used to save lives — and that means the U.S. Food and Drug Administration needs to throw its hat in the ring.
The independent research firm Soreon estimates the wearable tech for healthcare will grow from 2014's $2 billion to $41 billion in the next five years, targeting tools for diabetes, sleep disorders, obesity and cardiovascular disease, as Reuters reported.
To handle what will be an incredible upturn in the market, the FDA is looking to hire three senior health scientists to concentrate on digital health — just to take on what's sure to be a surge of applications from both the Davids and the Goliaths in the medical field. Massive companies like Alphabet Inc.'s Verily have already stated they'd be working with the FDA to get devices approved.
Neosensory, a sensory augmentation startup, has started looking into whether or not it needs FDA approval for a vest that would use haptic touch signals, like vibrating Braille, to teach people with hearing impairment to interpret vibration combinations as sounds and, eventually, words and phrases. Since the vest is noninvasive but still medical to a degree, Dr. Scott Novich, one of the founders, isn't sure how it will be categorized.
"If you want to make certain medical claims, you have to go through the FDA," Novich told Mic. "It becomes a question of if we want to make those claims with our technology. "We're just not confirmed one way or the other if we're going to end up seeking it."
Another example: Empatica is a wearable-tech company with its sights on a wristband to monitor epilepsy patients in the event of a seizure. It will need to go through the same process with the FDA. Its claim, according to Reuters, is that it "can reliably detect some types of epileptic seizures and send an alert to caregivers to check on them." It's claiming the ability to warn someone in a life-or-death event, therefore, it needs higher levels of scrutiny. Which is good. But it also needs to do the same legwork without the same firepower of a Google or an Apple.
It's a hassle. But this is how companies like Fitbit and Jawbone were able to avoid the process with their own noninvasive wearables: If you don't say something is going to save a life, you won't be scrutinized by the government. If you do, you need to go through the FDA's unimpeachably necessary regulatory process — if only to make sure your company isn't trying to screw people who need help.
As Amal Graafstra, founder of the citizen science gadget company Dangerous Things, told Mic, the FDA defines a medical device as something involved in the diagnosis of treatment or disease. But there are fast-track paths in place to get medical devices approved quickly to be used by labs, hoisting the liability upon whoever's using the device.
What's interesting here: Even though doctors are supposed to use FDA-approved devices data on things like Type 2 diabetes, they could use a Fitbit pedometer to receive similar information and there'd be less red tape. But using a Fitbit, which has come under fire for manufacturing with toxic silicon and having accuracy issues, to collect that kind of data could be a mistake — and there's no FDA scrutiny to prevent it.
"Let's imagine this was a 'vital signs' monitor that collected pulse, oximetry, blood pressure, et cetera, and there were similar issues discovered," Graafstra told Mic. "Medical device manufacture requires a much more stringent set of standards, and facilities that manufacture these devices use only [medical]-grade materials. ... It is really important that devices that wish to be used in a medical context need to get approval."
Graafstra says there's plenty of room for non-medical devices used in ways to help in a medical capacity — for instance, a heart monitor to check pulse and oxygen levels. But for things that make heady claims about their technology, there needs to be a gatekeeper.
"The propensity for companies to try and scam sick people out of their money knows no bounds," Gabriel Licina, a biochem researcher who found a way to create a temporary night vision effect on himself, told Mic. "The FDA is dumb, but they mean well. Your average American isn't educated enough about how biology works to make these calls, sadly. Sick and unhappy people will latch onto anything in the hopes it will work."
Reputable and highly funded companies are flocking to a futurist cottage industry currently cornered by citizen scientists and homegrown cyborgs, and that's a good thing. The FDA's tedious approval process is a good thing too. It means more accountability for new, uncharted technology. Morally ambiguous companies won't be able to sell Grandma a faulty pacemaker.
The unseen benefit: Best of all, the DIY community will have more access to technology that would otherwise cost millions to research and develop. Independent developers will have more toys in the sandbox. And the research they do independently could help shape the medical field thanks to some old-fashioned, garage-style guinea-pig testing.
"That's how you got the 3-D revolution — a patent became public domain," Tim Cannon, co-founder of Grindhouse Wetware, told Mic. "It's a trend now for companies to make their money and put the technology out in the open. We'll have access to a lot of cooler stuff just because these larger companies are looking into it. Being into human enhancement, this only helps me."
What's more, people like Cannon and Licina aren't stuck behind the red tape of big companies, who have to worry about investors, boards of directors or liability. "At a Google-sized company, you have to pay half a million dollars just to get some guys to come in and argue about the research," Cannon said. "That, just to find out they'd be too liable and they'd be fucked."