Medical data startup yields unlikely celebrity
Over breakfast in the ballroom of the Wyndham Garden York, a group of York County entrepreneurs and investors sat with rapt attention to hear the story of the region's newest star.
Madris Tomes, CEO and founder of medical data analytics firm Device Events, held the attention of the "Breakfast Club" of the York County Economic Alliance for nearly an hour, filling a void left by the absence of the event’s second speaker, who did not show
Taking questions from the crowd to fill the time, Tomes expressed surprise at the success of her York County-based company, which offers a searchable, user-friendly database of side effects and deaths caused by medical devices.
"I never expected to think of myself as an entrepreneur. When I left the FDA, I had a product I wanted to build, but my thought was always who is it going to help rather than what’s the bottom line going to be," said Tomes, who lives in Spring Garden Township.
As Tomes explained, she served as a consultant for Washington, D.C., contractors like Booz Allen Hamilton and CGI before working as a fraud analyst for the federal Center for Medicare and Medicaid Services.
In 2012, she joined the Food and Drug Administration as a public health analyst, where the agency’s handling of medical device data came to her attention. As Tomes explained, medical devices do not require the same level of clinical trials typically required of medications.
"For a medical device, most of them, 95 percent don’t go through clinical trials," said Tomes. This presents problems for people who may have adverse effects caused by implants, prostheses and more intrusive items like pacemakers.
As Tomes noted, if a patient is having a bad reaction to a drug, he or she can simply stop taking the drug. It’s more difficult to resolve issues caused by, say, a cataract lens or hip implant.
"If you get an implant, often it’s difficult to remove, if possible at all. The safety issues that come with adverse events, it takes the FDA two months to two years to identify a problem with a device," said Tomes.
The agency had invested $30 million into a system that, while open to the public, was mainly useful for internal FDA operations. For providers, patients, and investors hoping to learn more about a specific medical device, however, the FDA's system continually came up short.
"It was good for their day-to-day work, but it didn’t allow them to identify signals or patterns in problems with devices," said Tomes.
Tomes left the FDA in 2014 with a solution in mind. Whereas the FDA’s system only allowed for single-word searches, often yielding hundreds of thousands of reports about medical devices, she imagined and realized a simpler approach.
"You have 6.7 million reports and their system allows you to search based on one word. If you’re hoping to look up whether a hip causes metallosis or an allergy, you can only look up all the hips where there are 300,000 reports. Mine’s more like a Google search," said Tomes.
Device Events’ hope is to help doctors and hospitals identify faulty devices and device manufacturers, removing them from purchasing agreements and potentially saving lives. She mentioned a 2016 lawsuit from multiple patients against WellSpan Health, which patients claim exposed them to a deadly bacteria through a device used in heart surgeries.
After collecting a team of smaller investors for her software, Tomes launched Device Events in 2015 and soon had the attention of major players among physicians and patient advocates. Last October, Device Events was the recipient of $100,000 investment from AOL co-founder Steve Case’s "Rise of the Rest" competition for startups outside of the usual business hubs like New York City or San Francisco.
Before Rise of Rest, however, fame came knocking after an article appeared in a British medical journal using her software. Tomes was soon contacted by activist and legal researcher Erin Brockovich, most famous for Julia Roberts' depiction of her in a 2000 movie for which Roberts won an Oscar.
"Within a day, she was sitting in my dining room and telling me how I needed to stop worrying about whether there were 55 deaths or 56 deaths from a device and get the news out about it," said Tomes.
More so than the businesspeople in her audience at the YCEA breakfast, Tomes looked to Brockovich as a model to follow.
"I’ll never be Erin Brockovich; she’s amazing and so smart. But she gave me the kick in the butt to not be afraid to share what I was finding," said Tomes.
The York County Economic Alliance was having none of her humility - a woman from the crowd cheered her on by calling her "York County’s Erin Brockovich" to raucous applause.