$200 iPhone Case Is An FDA-Approved EKG Machine

| December 10, 2012

HEALTH
CARE IS HURTING, AND THE WORLD IS CHANGING. MORE AND MORE, HOSPITALS WILL FIT
IN OUR POCKETS.

Most iPhone cases just
protect your phone from drops. If you’re getting fancy, it may have a fisheye
camera lens or a screen-printed back. But what about diagnosing coronary heart
disease, arrhythmia, or congenital heart defects? The AliveCor Heart
Monitor
is an FDA-approved iPhone case that can be held in your
hands (or dramatically pressed against your chest) to produce an EKG/ECG–the
infamous green blips pulsing patient-side in hospitals everywhere.

“We think that EKG screening
can be as approachable as taking blood pressure,” AliveCor President and CEO
Judy Wade tells Co.Design.

There are already apps that
take your heartbeat, of course. But there’s a big difference between the
fast-paced standards of casual electronics and the strict sanctions of
government-approved medical devices. “The heartbeat camera apps are good at
wellness,” Wade admits, “but we see ourselves for use by people who want clinical-quality
equipment.”

“IMAGINE THE
POTENTIAL: IN-APP PURCHASE FOR A FOLLOW-UP APPOINTMENT.”

So unlike most iPhone cases
that are squirted by Chinese factories at extremely high margins, AliveCor’s
case has been in serious development since 2010. Aside from building the gadget
itself, to become approved for medical use by the FDA, AliveCor had to
participate in two clinical trials to field test both the hardware and the
accompanying app. One study investigated how its single-lead EKG compared to a
traditional 12-lead device, the other examined if 54 participants could figure
out how to use the case properly, with no previous medical training. The latter
study was not only successful but led to the diagnosis of two serious heart
problems.

1671371-poster-1280-ekg-alivecor-heart-monitor-untitled-1

THE
COMPLICATIONS OF INNOVATING UNDER THE FDA

AliveCor was lucky. Though it
took about six months to get the application ready, the approval arrived well
within the 90-day approval window, allowing the company to come to market
sooner. It was a necessary hassle; FDA approval opens a lot of doors.
Instantly, what could be considered some scam iPhone case was marketable to
health care professionals–doctors–who’d most likely pay out of pocket for a
$200 stethoscope replacement without blinking. FDA approval also allows doctors
to prescribe, and potentially have insurance cover, AliveCor’s device for their
patients to take home.

But even with an approval
in-hand, AliveCor will continue to juggle complicated regulations to stay
competitive in the market. For one, the approved monitor was designed for the
iPhone 4 and 4S. Before AliveCor can release an iPhone 5 version with the exact
same hardware internals, they will need to seek out additional FDA approval.
(With previous approval and clinical trials to cite, the process is mostly a
formality, but it’s still paperwork that takes more time and resources.)

“THE REAL
QUESTION IS, WILL FDA REGULATIONS LEAVE SPACE FOR THE LITTLE GUYS TO INNOVATE
RESPONSIBLY.”

The company also intends to
release an over-the-counter version of the case. The good news is, this device
will be eligible for coverage in most employee spending programs. But because
of FDA regulations, this OTC version cannot provide the raw EKG data to a
consumer who might not know how to interpret the esoteric waveforms. Instead,
AliveCor will redesign the app to provide an infographic-esque interpretation
of the EKG. “An EKG means something to a trained physician, but we can provide
a lot of insights to an untrained consumer that might help explain what
triggered a cardiac event,” Wade explains. “Like caffeine is a trigger. With an
app, we see being able to offer more insight to an individual about their heart
health.”

From a product design
standpoint, this second-level data analysis sounds like an ideal,
consumer-oriented decision. But from a consumer rights standpoint, why is any
government agency standing in the way of consumer access to our own raw data? I
can see how strongly my iPhone’s antenna is reaching the nearest cell tower,
but I can’t see how well my own heart is ticking inside my body? How absurd is
that? Interestingly enough, AliveCor is using this regulation to their
advantage, banking on the health care model as it stands now. Its OTC device
will offer services to refer you to a physician for deeper result analysis (and
access to your actual waveforms, if you’re so concerned), which will provide a
backend revenue stream beyond typical hardware sales. Imagine the potential:
In-app purchase for a follow-up appointment. 

THE
FUTURE OF MEDICINE

For the time being, AliveCor
is continuing to develop their EKG cases into a full line, including that OTC
device, which will also be a universal version working for both iOS and
Android. (Since the case actually communicates with the phone wirelessly, once
the software programming is done, these product differentiations are largely
cosmetic in nature.) No doubt, AliveCor sees the case as a stepping stone to
the company’s overall vision, that “everyone should have their health at their
fingertips,” Wade says. But the company will have to solve a lot of larger
problems that the industry is struggling with to make that future a reality.

“SHOULD MEDICAL
DEVICES BE REGULATED TO AUTOMATICALLY DIAL 911 IN CASES OF EMERGENCY? ”

While diagnostic devices may
be coming to the phone, we still have no standards to get such diagnostic
information back to our doctors. AliveCor explained to me that it can send a
push notification to my cardiologist every time I check my heart, but does my
cardiologist really want push notifications all day from their client list? Or
worse, would any doctor want a devastating cardiac episode just sitting under
30 other messages in the iOS Notification Center? Should my phone text or not
text emergency information? Should doctors be held accountable for app-based
information? Should medical devices be regulated to automatically dial 911 in
cases of emergency?

No doubt, AliveCor’s Heart
Monitor is another case of affordable consumer technology outpacing our
brick-and-mortar hospitals, but to the credit of our hospitals, affordable
consumer technology is outpacing most of the world. Still, just as Domino’s has
figured out to deliver me a pizza through an app (no doubt, saving a few cents
in the process), so, too, will the medical community come around to juggling
big data at the individual patient level. The real question is, will FDA
regulations leave space for the little guys–the weekend app warriors and the
Kickstarters–to innovate responsibly, at a price cheaper than clinical trials
and a timeframe faster than paperwork?

Pre-order the Heart Monitor here.

Source: Fast Company

 


Category: Pathology News

Comments are closed.