5 design tips from wearable neuromodulation device developer Avation Medical

Avation Medical co-founder and CEO Jill Schiaparelli says she’s convinced neuromodulation will soon become the third pillar of medicine, joining pharmaceuticals and surgery.

Beyond pacemakers and pain management, neuromodulation devices are being developed for anxiety, depression, sleep apnea, restless leg syndrome and more.

“This whole market of neuromodulation is moving toward wearable [and] neuromodulation so beautifully lends itself — especially peripheral nerves outside of the spinal cord — to different therapeutic applications,” she said in an interview.

“We really believe another frontier will be closed-loop,” she continued. “Ten years from now, people won’t just be randomly putting any old amount of electricity — it will be very highly calibrated. This is moving absolutely toward precision medication. We intend to be a part of that.”

Schiaparelli and her co-founder, Chief Technology Officer Manish Vaishya, developed the FDA-cleared Vivally System for treating urge urinary incontinence (UUI) and urinary urgency caused by overactive bladder (OAB) syndrome. The wearable, closed-loop neuromodulation device works with a smartphone app to deliver electrical stimulation to a patient’s tibial nerve for 30-minute therapy sessions at home.

Their device development and design offers some lessons for designing wearable neuromodulation devices:

1. Find an unmet need

Schiaparelli said she identified a “huge, unmet need” for patients with overactive bladders, which affects one in six adults.

“What’s really unique that I saw when I was co-founding the company,” she said, “is the FDA treatments were drugs, surgery and Botox injections [and] 90% of people with this horribly burdensome chronic condition basically said, ‘I don’t want any treatments. I would rather wear a diaper.’ And as a person who reads markets and has launched a number of startup products, I said, ‘There’s something here. We can do better.'”

She and Vaishya set out to develop a convenient, at-home treatment without drugs or surgery.

“This is a very patient-driven market,” Schiaparelli said. “If somebody tells me I need heart surgery to keep me alive, I’m going to have it. But when it’s a lifestyle condition, the playing board changes and the patient has a different set of calculus. They want efficacy, but they also have to have convenience and low side-effect profile. Otherwise, they’re going to say, ‘No thanks, I’d rather live with the condition.’ And that was the challenge we saw.”

It’s always important to understand user needs, but designing wearable devices that patients use at home — and almost anywhere else — requires considering the needs of patients, physicians and monitors.

“Make sure all of those needs are understood and that they’re incorporated in the whole product development,” Vaishya said.

2. Design for ease of use

“With this premise of shifting into the home, the technical issue we had to overcome is it had to work perfectly every time in the hands of a patient when there was no physician around,” Schiaparelli said.

The garments come in two adjustable sizes and can be worn on the left or right ankle. That makes sizing easy for patients and doctors while covering what Vaishya estimated was about 95% of the population.

When a physician prescribes the device, they start by calibrating it personally for the patient using the same app that the patient will use to control the device at home.

“We’ve made it so that for [a patient] who really doesn’t care, it’s a push button. You just start the therapy and you don’t have to do anything for the next 30 minutes. It automatically stops and powers down itself,” Vaishya said. “At the same time, for people who like to play with apps, there’s a lot of features. You can do diaries, there are videos. We try to kind of cover a large demographic, which is where a lot of medical device companies find it challenging.”

2. Design for low maintenance

Vivally’s wearable garment has reusable gel pads instead of single-use pads. This design choice lets patients go up to a month before replacing the pads. That increases patient compliance, particularly among older patients Vaishya said.

The system also runs on rechargeable lithium-ion batteries for user convenience.

“That keeps people from having to swap AAAs every time they use the system,” Vaishya said. “Charging is easy. You drop it in the socket, and you don’t need to charge it more than once a week.”

3. Comfort and durability are crucial for wearable devices

The Vivally ankle garment is made from a proprietary material that’s breathable and elastic for patient comfort. Avation Medical passed on neoprene because it wouldn’t be durable or comfortable enough.

For the Vivally system, flexibility, comfort and durability were key for a device that patients wouldn’t mind wearing as they went about their daily lives.

“People will do weird, crazy things — they will run with this thing, they will walk in a march — so we’re going to make sure it survives all of those,” Vaishya said. “And it’s breathable [to handle] perspiration.”

4. Collect and crunch data

The Vivally system collects data from the wearable device, transmits it to the app via Bluetooth, and stores it on the HIPAA‐compliant Vivally Cloud Database.

“Every day, we are literally collecting 100,000 data points for every therapy session. So it’s a lot of data we are going to be using for future learnings, phenotyping, AI and improving outcomes,” Vaishya said. “In the short run, we are really focusing on patient monitoring remotely and improving the compliance and monitoring if there’s any safety implication.”

He also emphasized the importance of taking time to be analytical.

“You cannot just build and test and try,” he said. “You’ve got to take a deep breath and just understand the engineering side and analytical simulation. I think those are indispensable, especially when it comes to a lot of interacting pieces.”

5. Take risks but have a backup plan

Innovation is risky, and failures are all but guaranteed. Especially for complex systems, make sure you have backup plans and parallel paths.

“We always had two or three paths we pursued during this whole time: different materials, different electrode printing processes, multiple control algorithms looking at EMG processing,” Vaishya said. “… Keep in mind that not everything is going to work.”

Read more from our interview with Avation Medical co-founders Jill Schiaparelli and Manish Vaishya: This device treats overactive bladder without drugs or surgery