Innovators jump through FDA hoops to create apps for doctors

By Carmel DeAmicis , written on September 19, 2013

From The News Desk

Ron Walker, athletic trainer at Tulsa University, held the iPhone to his chest. When it vibrated, he looked at the results measuring his balance on the Sway app, smiled, and said, "That is the future of my field." With the Sway app, Walker would be able to assess his athletes' concussions and other conditions objectively.

Compared to consumer fitness products like Jawbone or Fitbit, apps for medical professionals get very little attention. This is partially because they're just not that exciting -- who cares about mobile medical dictionaries? But it's also because FDA-approved apps that use phones for measurable medical tests are few and far between. In fact, the FDA only reviews twenty apps a year.

Any app taking the place of a device already regulated by the FDA -- like an ECG machine --must go through FDA approval first. That hurdle prevents some entrepreneurs from trying.

There's a handful of success stories among those who did. Vital Art and Science checks vision functionality by prompting patients to touch a demo. AliveCor turns a phone into an electrocardiogram for detecting abnormal heart beats. Gauss Pixel App lets surgeons estimate the amount of blood loss in surgery by taking a picture of the sponge used (ew). And an unnamed app in development takes your pulse by detecting changes in skin color when you put your finger on the camera.

Now, as of a few months ago, you can add Sway to that list for checking patient's balance. Chase Curtiss, founder of Sway, says, "My motivation was what a huge hole we have in the medical market. Equipment from the 70s and 80s, interests that want to keep it exactly where it is."

Curtiss was getting his master's while working in a neuropsychology lab when he decided to see how mobile technology could impact the medical field. After doing some market research, he found that a balance tester could be used by a range of professions from athletic trainers to physical therapists to pharmacists.

All iPhones come equipped with motion sensors, which allow you to switch from landscape to portrait view by turning your phone. It turns out the motion sensor is good enough to also read imperceptible shifts in a person's balance. Curtiss raised seed funding and found a developer to build the app, then raised more seed funding to go through the FDA approval system. He claims it was a breeze.

"It's not that difficult of a process if you approach it the right way," Curtiss says. "You just provide documentation showing you're going about the process in the right way, proving your software works right."

Curtiss may think FDA approval isn't an obstacle to innovation, but there are critics out there who would disagree. Investors and innovators are hesitant to tackle a market as complex and fraught with regulatory challenges as healthcare. Early efforts like Sway and the aforementioned apps are paving the way for future developments.

"The response we get with athletic trainers when we one on one sit down with them is immediately like, 'What? You can get that from the iPhone?'" Curtiss says. "The barrier is explaining how simple this is: think of an iPhone as a medical device."

[Image courtesy: Murray Barnes]