Identifying the Need for a Wearable Solution to Overactive Bladder: Insights from Market Research with Patients, Providers, and Payers : 38

Ohio-based Avation Medical has developed a bioelectric wearable device for at-home treatment of overactive bladder, promising improved quality of life for patients suffering from the most common cause of incontinence and urinary urgency.

In Episode #38 of the MedTech Speed to Data Podcast, Andy Rogers discusses the Vivally System, entrepreneurship, and more with Avation Medical co-founder Jill Schiaparelli.

Need to Know

• Bioelectric medicine is an alternative to pharmaceuticals and surgery — Selectively stimulating the nervous system can enhance, control, or fix a function without the tradeoffs of other treatments.
• Overactive bladder is a prime candidate for bioelectric solutions — Forty-five million Americans have overactive bladder, with nine million preferring adult diapers to traditional treatments.

Nitty Gritty
Although not fully understood, overstimulation of nerves in the bladder wall produces spasms, creating an urge to urinate as often as thirty times a day in extreme cases.

Few sufferers choose sacral nerve stimulation, the gold standard treatment, which requires a device implanted near the spine to stimulate nerves regulating bladder behavior.

“The moment you say surgery, it complicates things.” Schiaparelli explains. “You need a physician who knows how to do it, you need a patient who’s willing to have what could be a very extensive surgery, and you need a payer who’s willing to pay for the surgery.”

Drugs for overactive bladder have unwelcome side effects that cause most patients to drop out of the care pathway.

“When you look at those dynamics,” Schiaparelli says, “it screams a need. Patients want something that takes surgery out of the equation, doesn’t have the side effects of drugs, and is convenient.”

Avation Medical’s Vivally System is an ankle-worn device that indirectly stimulates the sacral nerve through the tibial nerve without surgery. The device measures responses to adjust its stimulation automatically in real-time.

“This physiologic closed loop allows the patient to have personalized, effective therapy in just thirty minutes once a week,” Schiaparelli says.

Data that made a difference
As a serial entrepreneur, Schiaparelli has learned that success requires understanding and meeting the needs of three key stakeholders: the patient, the physician, and the payer:

• Overactive bladder patients dissatisfied with traditional treatments are an enormous market.
• Most physicians can only offer prescriptions for imperfect drug therapies that do not generate revenue for their practices.
• Payers don’t like either option since surgery costs reach $40,000 while drugs require lifetime prescriptions.

“Every area we checked into, it made sense. This technology in this market checked all those boxes to say there’s a need. We thought this was a real opportunity to disrupt the market.”

But success requires addressing the needs of other stakeholders, including regulators and investors.

Regulators’ expectations, for example, drove Avation Medical’s decision to implement quality control processes while starting its first clinical trial. “We knew that was going to be very important because we planned to use the clinical trial with our FDA submission.”

Aligning Avation Medical’s investors’ expectations was just as important, with each investment round supporting the next stage in development and commercialization.

Schiaparelli takes a holistic perspective on a Med Tech startup’s data strategy.

“It’s speed, absolutely,” Schiaparelli says, “but it’s also intelligent data that speaks to the needs of all the people that you’ll need to demonstrate to down the line.”