Patient empowerment often is about taking care into one's own hands. Usually that means making a lot of noise or at least asking a lot of questions. Less common is the entrepreneurial path in search of a technological fix to a personal health issue.
Michael Seres, co-founder of London-based 11 Health, took the latter approach.
As Seres tells it, he was diagnosed with Crohn's Disease at age 12. Two years ago, he needed a bowel transplant and was fitted with an ostomy bag.
"When you get fitted, there are a lot of problems with it," Seres said, not the least of which is that it is difficult to know how full the pouch is or when it is time to empty it. "As an ostomy patient, you don't know how big it will expand." The only way to guess is to see visually that the bag has expanded, but that is an inexact science, one that also happens to be impractical when the patient is asleep.
Seres wanted a mobile app of some sort to alert him when the bag is filling, but was unable to find one. "For some reason, the ostomy industry hasn't embraced technology," Seres told MobiHealthNews via Skype. So he decided to build his own, first making prototypes with parts he picked up on eBay, before finding that a strip in a Nintendo Wii handset could accurately measure pouch fullness by sensing the arc of the bag's external curvature.
The result is Ostom-i Alert, a sensor-enabled device that clips on to an ostomy pouch that "sweeps" the bag every few seconds, then sends measurements via Bluetooth to a smartphone. A companion app can alert the patient when a bag is filling up and send data to a Web portal that the patient can share with caregivers to track output trends over time. "This device will automate a report for your physician," Seres said.
"You'd know in advance if you could empty it without any problems," Seres explained. Alerts can be set for any time, including to notify the user if the bag is filling up overnight. "Just leave your mobile phone by the bed and set an alarm," he said.
The system, which sells for $79.99 (€59.99 in the eurozone and £49.99 in the UK), debuted at the United Ostomy Association of America's biennial conference in August with an iPhone app. An Android version followed earlier this month, and the company also is just beginning to move to a Bluetooth low-energy transmitter on the sensor.
Seres said Ostom-i Alert has U.S. Food and Drug Administration clearance for sale as a Class I medical device, as well as Medicines and Healthcare Products Regulatory Agency approval in Britain and a CE Mark that covers the rest of Europe.
For now, 11 Health – so named because Seres was just the 11th person in the UK to have bowel transplant surgery – is marketing the product only through its website, though Seres said the company is about to begin clinical trials in U.S. hospitals in hopes of securing approval to sell Ostom-i Alert to institutions.
"The next step is to embed this in hospitals," Seres said. The software is designed so one physician or nurse can track as many as 20 patients from a single iPad.