More than 1 million people are diagnosed with diabetic foot ulcers each year, forcing them to face potentially debilitating medical treatments—including amputations—and costs. The condition is notoriously difficult to detect early on and has particularly devastating impacts on the veteran population, which faces an increased risk of developing it.
But the evolution of a cutting-edge ulcer-detecting device, originally thought up at a hackathon promoting public-private partnerships in 2011, demonstrates the unique opportunities the Veterans Affairs Department can offer health care startups to design and implement successful solutions. Today, that device—Podimetrics’ SmartMat—is making its way to VA clinics and other health care providers across America.
“Companies will come to us and say ‘why did you start in the VA? That doesn’t make any sense,’” Jon Bloom, the co-founder and CEO of Podimetrics told Nextgov. “And yet I think it’s completely the other way around. If you want to have immediate impact it might take a while to get into that system, but once you are there, it makes it all worthwhile in the end.”
Bloom’s SmartMats are now at 14 VA centers across the nation and in May, Podimetrics received more than $13 million in funding, which the anesthesiologist-turned-entrepreneur hopes to use to expand its reach. On Friday, the agency’s Office of Health Equity announced it has entered the collaboration and is funding an initiative to bring the budding tech to VA providers throughout North Carolina and Virginia.
But the spark that made the innovation possible was the first Massachusetts Institute of Technology’s first Hacking Medicine Grand Hack, which joined together academic, industry and federal innovators to accelerate medical innovation.
At the event, another attendee said they wanted to find a solution for diabetic foot ulcers—something that immediately resonated with Bloom. His father is a veteran and he has distinct childhood memories of going to VA appointments with his dad and meeting other veterans who were in wheelchairs.
“Of course as a kid I always thought that these amputations were all from trauma and combat, and then I found out later in medical school it was really mostly caused by diabetes,” he said. “That was a very formative view—that memory of him talking to friends who are in that situation. And then years later in the operating rooms I’d do whole days doing blocks for amputations.”
Bloom joined a unique team of thinkers who he said could really only come together at such an event. Their team was comprised of a sensor engineer, mechanical engineer, someone with a background in machine learning, an ex-banker and Bloom, who was a physician and medical director at the time.
“We were five complete strangers, different voices and we had random skill sets. But we came together and sat down at this table and gave life to this crazy idea,” Bloom said. “People didn’t have those lenses before and they had never attacked this problem with these kind of skill sets.”
Diabetic foot ulcers cause complex challenges for patients and the entire health system and Bloom realized early on that in order to create a real solution, the team needed to produce something that patients could easily use to check for ulcers over and over again.
Prior to the SmartMat, the primary way patients could examine themselves for the ulcers was to use a cumbersome handheld probe to receive numbers for six separate spots on each foot. They’d use those numbers to calculate the delta temperatures, or symmetry from those six matched pairs on each foot, and then track the numbers over time. If they exceed a certain temperature for multiple days, patients would need to seek medical attention.
“It took meticulous note-taking and a lot of emotional organizing,” Bloom said. “If they saw a bad number, you had to hope they understood what that meant and that they actually notified their medical professionals or knew what to do—and there were so many points of failure on that.”
Because they are so hard to track, the ulcers frequently become infected and are also one of the leading causes of amputations in the VA. The mortality rates after a foot ulcer are also remarkably high. Bloom said he’s seen firsthand how the condition would also cause many patients to suffer from serious anxiety and depression.
“They don’t feel like they have control over their body or over their lives. And it’s a killer, this disease,” Bloom said. “It’s just a devastating complication.”
At the first hackathon, Bloom’s team came up with what he says is “the core” of their great idea: an alerting system and feedback loop. Essentially, the team sought to create a monitoring device with a strong alert system and a feedback loop that would allow nurses or coaches, in many cases VA podiatrists, to proactively reach out if patients ulcer detecting rates showed complications.
The team went on to win the first hackathon with their innovative monitoring idea. From there, after a few setbacks and more success at similar technology acceleration events, the team went around to diabetic focus groups to work directly with patients to figure out what device they’d feel most comfortable using. They tried smart socks, shoes and insoles, but ultimately realized the best bet would be a mat that patients could use as they would a scale. After placing their feet on the connected mat, patients’ data is sent to the company’s care management team, which triages any concerning findings.
“It fits so well with existing mental models,” Bloom said. “Ultimately, patients were just so comfortable with stepping on something for 20 seconds a day then going on with the rest of their lives.”
Two years after founding Podimetrics in 2011, the device was designed and Bloom and his team needed data to prove that the tech actually worked. A VA clinician he’d been working with in California recommended they run a clinical trial. The clinician went on to design the trial, which included three VA clinics in the seven centers testing the tech. The study demonstrated that Bloom’s SmartMat could detect 97% of certain foot ulcers more than five weeks before clinically presented. The trial was deemed a success.
By the next year, the device was cleared by the Food and Drug Administration and Podimetrics made its first commercial sale—to the VA—in 2016.
“It’s really been overwhelming to work with people like [Bloom] and learn about emerging tech and different innovative solutions that are being developed and designed in the private sector that could have such a profound impact on our patients,” said Suzanne Shirley, a social worker with years of federal experience who is now serving as an entrepreneur in residence for the Veteran’s Health Administration’s Innovation ecosystem. “Twenty-four percent of our patients have Type II Diabetes and just an enormous number of them have highly complex social risk factors as well. This is an impactful solution.”
Through the innovation ecosystem, Shirley works with public and private innovators to improve patient care and infuse the agency’s enterprise with disruptive solutions like Bloom’s. Together Shirley and Bloom are working to scale the mats to other VA facilities and socialize the SmartMat as a solution that can really change veterans’ lives.
For Bloom, the ultimate goal is clear: No more diabetes-related amputations across the VA.
“I don’t know if that’s a goal we would ever do alone, there’s probably a lot more to it than what we do, but we are trying to get this out to those veterans that have the greatest risk,” Bloom said.
So far, it’s working. Recidivism is a critical component of ulcer tracing and treatment and a recent evaluation found that after one year, 70% of veterans were continuously engaged with the technology. He said that stat is significantly higher than in any other patient population and he believes it will get even better with time.
“We even have patients in homeless shelters at some of our VA sites—they are using it religiously. So to see that it has such a high adherence stat, that has been such an unbelievable part for us,” Bloom said. “So hopefully that by the work we’ve done it will have an impact on veterans lives, and now thinking really big, we can change the way we care for diabetes.”
As the single largest integrated health plan in the country, Bloom believes VA offers innovators an “unbelievable opportunity” to provide new care for those that need it most. Though it can be intimidating and there are often many siloes and channels to work through, he said it’s the one place that’s helped shape his startup’s mission and accelerated it. This week, Podimetrics also unveiled a new method to predict diabetic foot complications on amputees, who only have one foot to monitor.
“It’s absolutely been worth every minute—even when it can be frustrating—it’s definitely worth every minute to try to really work with that [VA] system,” Bloom said.
And the public-private collaboration is also helping agency insiders meet their own goals as well.
“Everyone at the VA serves the same mission: we want to improve the lives of veterans. But we can’t do it alone. So we need to meet entrepreneurs and people who have dedicated their lives to designing the right solutions like [Bloom] and his team,” Shirley said. “And when we meet those people and we can infuse our health care system with these solutions it really changes lives. It changes the way that we function as a health system and when it goes beyond the VA, it can change the world.”