Medical Devices

Device design: Wearable diabetic neuropathy pain management system strives for simplicity

Sensus from NeuroMetrix

Sensus from NeuroMetrix

When Massachusetts-based Neurometrix (NURO) created a wearable device for pain management for patients suffering from diabetic peripheral neuropathy (DPN), founder and CEO Shai Gozani knew usability was key. More than a quarter of diabetic patients must cope with DPN, a burning, stabbing, acute pain, usually in the legs and feet, Gozani said. The Sensus, NURO’s nerve-stimulator that eases that pain for diabetes patients, needed to be wearable, durable and above all, simple.

Sensus can be worn on the calf and delivers an hour of stimulation to ease pain with the press of a button. Some patients may only need the wearable DPN treatment once a day, some patients may need as much as eight to 16 hours of stimulation a day, Gozani said. It can be put on while the patient is getting dressed in the morning and worn throughout the workday. It even has a setting to deliver treatment for pain management every other hour, so a patient doesn’t need to adjust the device if they’re busy or caught up during the day.

Diabetes treatment already involves many medical devices and drugs. Gozani didn’t want the device to become part of that problem. “We wanted to make this as easy to use as taking a pill. Because really that’s the alternative in a sense–a pain pill. . . . The last thing they need is another complicated device to try to manage everything else going on in their lives,” he said. “If it couldn’t be done with one button, that was too complicated in our minds.”

Easier said than done. The marriage between the mechanical–a hydrogel bioelectrical interface with a disposable electrode–and the form necessities, something lightweight that could be worn while the patient’s moving or at rest, can handle sweat and be adjustable, and fit under a pair of pants was a big step alone. But NeuroMetrix pushed.

But what Gozani called the “one-button simplicity” that the company strived for was perhaps its biggest obstacle. It required lots of automation and heuristic knowledge, he said, because the user doesn’t “dial in” what strength of stimulation they need or for how long. They just press the button and go.

The next generation of the device, which Gozani said should be out in the first half of 2014, will be even simpler: a third thinner, with some wireless options, including RFID capability. That capability will allow the RFID to “talk” to electrodes, which must be replaced about every two weeks, and will stop the device from trying to stimulate when electrodes need replacing to improve patient comfort and safety. It will also track usage characteristics.

The company also plans to allow the device to send information, such as therapeutic data, to a smartphone, Gozani said.

And, of course, wearables are becoming more fashion statements than cumbersome medical devices. Gozani said he “wouldn’t go as far as calling (Sensus) a fashion accessory yet, but maybe someday.”

Why diabetic neuropathy?

NeuroMetrix was a point-of-care nerve-stimulation diagnostics company when it went public in 2004. But in the late 2000s, “dramatic changes in reimbursement affected our market in really substantial ways” that made it “very hard to progress with such a broad base of clinical application,” Gozani said. Rather than crying over spilled milk, the company decided to fix its efforts on a big market that’s clinically narrow.

“It was no great stroke of genius to focus on diabetic neuropathy,” he said.

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