i3 - May/June 2018 - 35
An opioid crisis is gripping the nation as the search
for pain relief has turned into an addiction for many.
"You've got people suffering and the easy approach
was just to write a prescription. But there are a lot of
side effects with medications," says Frank McGillin,
chief commercial officer of NeutroMetrix Inc., a
Boston digital health and neurotechnology company
that offers an alternative.
Quell is a wearable neurostimulator that uses
electrodes to transfer current through a person's
skin to stimulate sensory nerves. That activates the
body's natural pain response, triggering production
of enkephalin, a powerful natural opioid that blocks
pain signals to the brain. About 100 million
Americans (one out of three) have chronic pain,
and half of them don't get complete relief from
medications, McGillin says. Others become
addicted. "We're basically enabling people to get
on with their life," he adds.
Quell looks like a strap worn to monitor heart
rate during a workout but is worn on the upper
calf where there are lots of sensory nerves. The
device captures data from users so it can deliver
an optimal dose of stimulation for each person.
It even checks the weather to let people know if
rain or cold is coming and gives them the option
to increase their stimulation levels to compensate. The app lets users track their self-reported
pain scores, sleep patterns, activity and gait
(which is correlated with pain levels.)
Quell, with 150,000 customers, has reduced
pain for 81 percent of patients with chronic pain.
And 67 percent of users cut or eliminated their
pain medications, McGillin says.
Kvedar says, "There's an enormous amount of
promise in digital therapeutics but we still have
a few things to iron out."
CTA's Digital Health and Fitness Division views opportunities in digital therapeutics as a growing market and is making efforts in the area.
* RESEARCH: CTA research tracks the rise of digital therapeutics and trends in the larger category of health and fitness
technology. In February, CTA released the study, Assessing
the Landscape for Digital Therapeutics.
* REGULATION: CTA worked with the Food and Drug Administration on what should be regulated, since wearables and
apps are a new phenomenon for an agency accustomed to
medical products. Last year, the FDA announced a program
to streamline its process for companies in a precertification program aimed at keeping up with innovations in digital health technology.
* REIMBURSEMENT: CTA and other groups have lobbied the
Centers for Medicare and Medicaid Services to reimburse doctors for remote patient monitoring, such as reviewing blood
pressure readings captured by patients on their devices.
* STANDARDS: CTA has developed voluntary standards for counting steps, monitoring heart rates and capturing sleep patterns.
C TA . t e c h / i 3