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 Unlike popular fitness-tracking devices, such as Fitbit Inc's
Fitbit and Jawbone's UP wristbands, these so-called medical-grade
wearables require approval from the U.S. Food and Drug
Administration - a rigorous regulatory hurdle that first-generation
wearables sought to avoid.
The FDA is preparing for the coming onslaught.
Bakul Patel, FDA's associate director for digital health, told
Reuters the agency is reviewing applications for three new senior
health scientist positions focused on digital health.
Long criticized by some health-tech entrepreneurs as a barrier to
innovation, the FDA is now seen as an important ally by companies
eager to show that their devices can improve peoples' health - and
eager to get heath insurers to cover them.
"Consumers, doctors, payers all want to know if a product provides a
clinical benefit," said Julie Papanek of the venture capital firm
Canaan Partners, who invests in wearables startups. "Working with
the FDA is the one way to get the ability to market that benefit."
 Many would-be vendors of medical wearables are small startup
companies, such as Cambridge, Massachusetts-based Empatica, which is
developing a wristband designed to alert epilepsy patients and their
caregivers of seizures in the hope of averting a dangerous
post-seizure condition that can cause sudden, unexpected death.
Like many emerging wearables companies, Empatica hopes that its core
technology will also find uses far beyond one specific medical
condition. Empatica founder Rosalind Picard, a Massachusetts
Institute of Technology professor and inventor, told Reuters the
company has just started large clinical trials using its wristband
device on individuals with depression.
The behemoths of the tech and healthcare industries are also chasing
medical wearables. Dr. Jessica Mega, a former Harvard cardiologist
who is now chief medical officer at Alphabet Inc's healthcare unit
Verily, said at a recent digital health conference that the company
plans to work closely with the FDA as it develops its own
medical-grade devices.
Soreon Research estimates the smart wearable healthcare market will
grow from $2 billion in 2014 to more than $41 billion in 2020, with
diabetes, sleep disorders, obesity and cardiovascular disease
representing the biggest growth segments.
To win acceptance, though, medical wearables companies will need to
do much more than reliably collect data from sophisticated sensors.
They will also need to develop the analytical capabilities to make
sense of it all, and prove in extensive studies that they can
improve patient health.
"The sensors are fantastic overall for collecting data," said Dr.
Eric Topol, a digital health expert at the Scripps Translational
Science Institute. It is the "data analytics and the clinical
utility parts that most of the companies haven't figured out yet."
WINDING ROAD
Empatica's experiences to date show the winding road that many
digital health technologies follow before they arrive at an
FDA-approved product.
Besides tracking sleep, motion and heart rate, Picard's device
tracks physiological stress by measuring skin conductance - changes
in electrical signals in the skin that correlate with the
sympathetic nervous system, which in turn regulates the "fight or
flight" stress response.
The device was originally developed to detect stress in individuals
with autism who have difficulty communicating their emotions. Picard
became interested in epilepsy when a student in her lab borrowed a
pair of the devices for his autistic brother, who had a grand mal
seizure while wearing them.
The event produced a surprising spike in electrodermal activity on
one side of the body that set Picard on the path of seizure
detection.
Empatica raised $2 million last year in seed funding from angel
investors, and more than $700,000 in an Indiegogo crowdfunding
campaign for its first consumer device, called Embrace, which it
hopes to start shipping early next year.
The company is also seeking FDA approval for its E4 device, a
research-grade version for use in clinical trials. Empatica will use
that to help gather evidence for future medical claims.
Papanek likes that strategy, saying: "You can use the clinical trial
platform to help validate the hardware and software that powers both
the consumer and the industrial versions of their product."
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Picard ultimately hopes to develop a way to predict seizures based
on patterns divined from data in her device, but that will take more
study. For its first FDA application, Empatica wants to make a
simple claim: that the device can reliably detect some types of
epileptic seizures and send an alert to caregivers to check on them.
Such alerts might help prevent sudden unexpected death in epilepsy
or SUDEP, which kills 1 out of every 1,000 patients with epilepsy.
If seizures are uncontrolled, the risk of SUDEP jumps to more than 1
in 150, according to the Epilepsy Foundation. Death is typically
preceded by seizure and most deaths occur when people are
unattended.
There are several other epilepsy sensors on the market, such as
Smart Monitor's SmartWatch, which detects repetitive shaking. Most
are not covered by insurance because they are not FDA-approved, but
that could soon change.
Anoo Nathan, founder of Smart Monitor, said the company has done
validation studies and is preparing for an FDA submission.
"It's definitely part of our roadmap," she said.
Dr. Tobias Loddenkemper of Harvard Medical School's Boston
Children's Hospital, who owns part of the Empatica patent, tests
several different types of sensors. He hopes to do large studies
using different combinations of sensors and drugs to find out which
offer the best results for individual patients.
Loddenkemper said he is in talks with unnamed drug companies to
devise systems that would use wearables and other data to manage
patients with epilepsy.
"If we can prove these devices and warning systems are keeping
patients out of the intensive care unit," he said, there is a chance
that hospitals will pay for them.
DATA RACE
A key driver in the new wearables wave is the push for so-called
value-based healthcare that is part of the Affordable Care Act. The
law gives doctors and hospitals financial incentives for keeping
large groups of patients healthy.
Under the old fee-for-service model, hospitals got paid when
patients were hospitalized, noted Jody Ranck, a Washington,
D.C.-based healthcare consultant. "Now, you can lose money," he
said. Instead, healthcare providers are now eager to collect the
data that can help keep people out of the hospital - especially
those with chronic diseases. "These wearables are just tools to get
the health data," said Ranck.
An avalanche of studies - many of them taking advantage of new
data-gathering platforms such as Apple Inc's HealthKit, Google's
Google Fit and Samsung's SAMI - are under way on a number of chronic
diseases, especially in the area of diabetes. "We're going to see a
lot of devices over the next couple of years for every chronic
condition of mankind that are FDA-regulated because they all involve
a treatment loop," Scripps' Topol said.
Verily's Mega, speaking at a Scripps digital health conference in
October, said companies will need deep analytics to tease out known
signals, like fluctuations in glucose levels or abnormal heart
rhythms such as atrial fibrillation.
But machine learning technologies will also make it possible to
discover "unknown signals," such as the significance of skin
conductance for a variety of conditions.
"Maybe that's a much earlier signal of a heart attack than we
actually know. These unknown signals take additional analytics,"
Mega said.
(Reporting by Julie Steenhuysen; editing by Jonathan Weber and G
Crosse.)
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reserved.]
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