A wireless shoe insert meant to help people manage diabetic peripheral neuropathy goes on sale Wednesday after some significant design changes from an earlier prototype delayed the release by nearly a year.
Orpyx Medical Technologies, of Calgary, Alberta, is introducing the SurroSense Rx system to U.S. customers only through its website, in men's sizes 5-13 and women's sizes 6-12. Early orders will ship by mid-December, according to Amanda Hehr, Orpyx's vice president of business development and marketing.
SurroSense Rx collects data about where people are exerting pressure on their feet—too much heel pressure can cause foot numbness—and alerts wearers when they are at risk for diabetic foot ulcers that could lead to amputation.
The product is considered a Class I medical device in the U.S., and thus exempt from FDA 510(k) review, Hehr told MobiHealthNews. However, the SurroSense Rx is classified differently by Health Canada, and thus will not be available north of the border until early next year, Hehr said.
Orpyx already has received a CE Mark to sell SurroSense Rx in the European Union. Hehr said she and a colleague will be at the huge Medica trade show in Germany next week seeking European distributors.
In addition to the direct-to-consumer sales through orpyx.com, Orpyx will distributing SurroSense Rx through podiatry clinics starting next month.
The complete package of sensor insert, wireless-enabled "shoe pod" data hub, specially designed smart watch, app downloads and access to an online tracking portal, costs $695. The inserts should last for 12-18 months, after which time they can be replaced for $325, though Hehr said the price should drop as sales volume goes up and the manufacturer gains production efficiencies.
The commercial debut of SurroSense Rx is quite a bit different from a prototype shown in July 2012. "We did a lot of user testing and realized we had to go back to the drawing board," Hehr said. This also put production at least nine months behind the original schedule.
Notably, Orpyx scrapped plans to power the shoe pod with a coin-style battery, opting instead for a rechargeable battery with USB charger for greater reliability. "It made it more user-friendly," Hehr said. "And the design was more elegant."
Orpyx also decided to funnel all data and alerts through the watch, over a wireless ANT+ connection (a Bluetooth Low Energy version is in the works), rather than offering the same service in a smartphone app. Testing revealed that people did not always pay attention to alerts on their phones, according to Hehr. "It's important for users not to miss alerts," she said.
In addition, the small team at Orpyx did not want to be part of the development "rat race" of having to keep up with constant stream of new Android devices, Hehr added.
While smartphone apps still are available, they will not collect data or provide feedback, Hehr explained. Instead, they will offer mobile access to a portal called Orpyx Connect—another addition since testing began—which tracks progress over time. "We've sort of gamified it," Hehr said.
Initially, U.S. customers will have to pay out of pocket for the SurroSense Rx system, though Hehr said the company will be applying for a Medicare Healthcare Common Procedure Coding System (HCPCS) code after the first of the year. She added that Orpyx has been in conversation with several large private health insurers about possibly covering SurroSense Rx for preventive care.
The system also is involved in two trials in hopes of building an evidence base for its efficacy, Hehr said. The University of Arizona is running a pilot involving about 30 patients, while the University of Manchester in the UK is preparing a randomized clinical trial with 200 patients, she said.
For more, view this video from Orpyx.