Regional One Health’s Center for Innovation was created to give medical startups a real-world environment to evaluate their products, technology and business model.
Recently, they celebrated a major milestone as Access Incubator participant Augment Health completed a scope of work to evaluate its business and clinical use case.
Thanks to what they learned, Augment Health officials say they feel more ready to take the next steps toward getting their product on the market so it can improve patient care.
Regional One Health’s Center for Innovation is celebrating a milestone with Augment Health, an Access Incubator participant that is developing technology to improve neurogenic bladder care.
Alejandra Alvarez, Chief Innovation Officer, said Augment Health recently completed its scope of work for evaluating its business and clinical use case.
“Participants can come into incubation at any point in the development cycle,” she explained. “They can be with us from the very beginning until their product is ready for commercialization, or they can come in any time they need validation for their clinical use or business model.”
Augment Health, a Nashville-based startup, is developing a system that includes an electronic sensor to monitor bladder fullness and other bladder health parameters along with a clinician-facing dashboard that supports improved treatment outcomes. The technology would replace a urine bag with a small electronic sensor that remotely monitors bladder activity and supports clinician decision making by communicating information about key events.
The goal is to help patients with neurogenic bladder, a condition that impacts bladder sensation and control due to brain, spinal cord or nerve problems, avoid embarrassing events, inconvenience, and even kidney damage.
“We wanted to take an issue where patients saw flaws in what was being provided and make the experience better,” said Stephen Kalinsky, Augment Health Co-Founder and Chief Technology Officer. “As we spoke with patients, we learned many of them wanted their urine storage issues solved more than anything, even more than wanting to be able to walk again in some cases. That was so impactful to us, and we knew this problem was the one we had to solve.”
After starting in the Memphis-based ZeroTo510 medical innovation accelerator, they looked to the Center for Innovation and Regional One Health to take the next steps.
At Regional One Health, the Center for Innovation helped Augment Health meet with officials in billing, procurement, materials management and more.
“When we finished the accelerator, we had all of these foundational elements, and we needed to build on top of those,” said Jared Meyers, Co-Founder and Chief Executive Officer. “That’s where programs like the Access Incubator play a big role and offer an incredible amount of resources.”
Meyers said it can be hard for startups to get solid data and information about how providers and patients would use their product.
“By working with Regional One Health, we were able to get information on a hospital system level, which was really helpful for us,” he said. “We were able to ask questions and get real data and information that helps us continue on our trajectory.”
To help evaluate Augment Health’s business model, Alvarez and her team at the Center for Innovation connected them with departments at Regional One Health including materials management, procurement, billing and urology.
“When we help a company to validate their business model, we help them understand realistic scenarios of working within a health care system – who needs the product, how they’ll pay for it, how it will become profitable, etc.” she explained.
Alvarez said there can be many insights gleaned.
For example, billing for medical products isn’t always as straightforward as sending out an invoice and receiving a matching payment. Billing can involve issues like splitting a cost among several line items, bulk purchasing, different charges for materials vs. services, etc.
Another area that often requires study is how a product will reach patients. In Augment Health’s case, the monitor is designed to be used remotely, so conversations involved whether inpatient services or outpatient pharmacy would take the lead on procurement.
Augment Health ultimately hopes to provide technology that can help patients with neurogenic bladder improve their care and quality of life.
“They had to work through those nuances,” Alvarez said. “It wasn’t always black and white, and there were a lot of eye-opening moments. Now, they’ll compare the information they gathered here to their existing understanding of their business model and make changes based on that.”
Kalinsky and Meyers look forward to taking those next steps.
“Speaking with clinicians and validating our business case was helpful to see how providers and patients would interact with the technology,” Kalinsky said. “It’s all actionable learning, and it’s helping us move onto the next phase.”
In the year ahead, they’ll focus on completing clinical studies, attaining FDA clearance, and starting the process to commercialize the product. Meyers said they are excited about how their technology can improve the care patients receive.
“We hope to support a better diagnostic process. Right now, patients have to report their own symptoms, so they have to remember when they had bladder problems and the severity of their problems. Our technology will track them day-to-day so they have that information,” he said.
“We’re also excited about expanding the availability of care. Rural communities don’t always have access to large academic hospitals, or patients don’t have transportation. This can expand what doctors can do remotely and help them decide if a patient needs to come in for treatment.”
As Augment Health moves forward, there is an opportunity for them to work with the Center for Innovation again. Alvarez said if necessary, a second scope of work could involve testing the technology with Regional One Health providers and patients.
“Once they’ve made changes and gone through the FDA process for clearance, if they feel they need a clinical evaluation, we’ll discuss engaging in a new incubation session,” she said.