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Why patients should be kept in mind while developing devices

What does true innovation look like in medtech? As an industry, we need to evaluate the needs of a market with fresh eyes and from different perspectives. We need to challenge ourselves and ask, “How can we do even better?”

My answer is: “Start with the patient in mind!”

At Avation Medical, before we even started working on designs for our breakthrough treatment option for overactive bladder, we spent months understanding patient perspectives – how their symptoms and (perhaps most importantly) available treatment options affected their lives. This led us to envision a product that has set a new bar for OAB therapies: The Vivally System.

Vivally is the first FDA-cleared, closed-loop, non-invasive wearable neuromodulation system, with a mobile application, to treat patients with urinary incontinence and urinary urge, common symptoms of overactive bladder.

Overactive bladder (OAB) may sound trivial, but it is a chronic, progressive condition with a constellation of symptoms that include urinary urge, urinary frequency, urinary incontinence (UI), and disrupted sleep due to night-time voiding. People with symptoms think about their condition 24 hours a day because it impacts every aspect of their lives. They adopt behaviours to compensate for their condition — constantly scanning for bathrooms while out in public, choosing to wear dark pants, carrying a change of clothing, and frequently excusing themselves from work meetings. As their symptoms progress, they may avoid social situations altogether. People with OAB have increased rates of anxiety and depression. Many have decreased work productivity, and some experience job loss.

OAB is incredibly common, impacting 1 in 6 adults. If you are picturing your father’s elderly Aunt Edna, you might be wrong. OAB and Urinary Incontinence (UI) affects men and women, and adults as young as 18.

Despite the availability of many different treatment options for OAB, most patients drop out of the care pathway or choose not to be treated for their symptoms. Why? Because current options all have drawbacks that cause patients to simply say, “No, thank you.”

The numbers tell us all we need to know. Of the 42 million people currently living with OAB and UI in the U.S., less than 20% have been treated with drug therapy. Less than 3% (i.e., fewer than 1 million people) have been treated with invasive therapy.

When developing Vivally, patients told us they would rather wear a diaper or simply try to endure life with their symptoms rather than be treated.

It’s not hard to see why consumers say no to these treatment options. Medications have undesirable side effects, including increased risk of dementia, and patients worry about interactions with other medications. Invasive options like Botox require multiple injections into the bladder wall through a cystoscope in a procedure that needs to be repeated every six months and is associated with urinary retention (which can require self-catheterization for weeks or months). Percutaneous tibial nerve stim requires a puncture from a needle-electrode into the ankle and weekly travel to a physician’s office to receive therapy. Sacral nerve and tibial nerve implants require major surgery, a permanent foreign body, with the potential for reoperation and scarring.

As medical device innovators and disruptors, we are taught to focus on safety and efficacy. But those standards are not enough. Successful therapy, including for OAB, must also be patient-friendly and eliminate the drawbacks of currently available options.

For Avation Medical, that meant a non-invasive, drug-free, surgery-free, and implant-free solution. It also meant a therapy that is comfortable, easy, convenient, personalized for each patient’s unique needs, and partnered with a mobile app that provides an e-diary to drive awareness and therapy compliance.

The Vivally System achieves these goals and is the first FDA-cleared, closed-loop wearable therapy system with a mobile app. Vivally works by delivering an electrical signal to the tibial nerve through a wearable device on the ankle. The electrical signal travels through the peripheral nerves to those that control the muscle surrounding the bladder. Vivally allows patients to perform physician-prescribed therapy in their own homes when it is convenient for them, and treatments are done in as little as 30 minutes, once per week.

Closed-loop technology provides several benefits. Vivally calibrates therapy to the patient’s own EMG signal (an indicator of nerve activation), allowing the physician to establish a personalised therapeutic output range for each patient, and sensors built into the garment continuously provide objective confirmation that the target nerve is being activated during therapy. Proprietary algorithms automatically adjust output in response to patient movement, allowing wearers to move about freely during therapy and be confident that the nerve remains sufficiently stimulated. Ensuring consistent nerve activation means that only minimal stimulation is needed to achieve a positive therapeutic effect, which improves user comfort. Two multi-centre clinical studies performed with Vivally delivered efficacy rates that rivalled implantable neuromodulation, and showed high patient satisfaction, good adherence to a therapy schedule, and improved quality of life.

Finally, the non-invasive profile of the Vivally wearable also means that neuromodulation therapy is now accessible to patients earlier in the care pathway.

To innovate is to imagine a better future for patients, and then build it. Even though young start-up companies like Avation Medical face many hurdles — financing, regulatory, reimbursement, technical, supply chain, and more – when the patient is top of mind, the focus remains on the outcome, and the goal can be realised. Med-Tech Innovation

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