M2S President and CEO Gregory Lange. Photo by Erika Cohen.
The Food and Drug Administration (FDA) closely monitors the medical devices it approves for use in patients. And with increased FDA oversight comes more business for M2S, a Lebanon-based health care IT company that creates cloud-based clinical registries used nationwide to track and analyze data from more than 360 hospitals and more than 230,000 procedures. M2S runs and maintains 12 clinical registries related to procedures using devices for both vascular surgeries (devices used in vessels outside the heart and brain) and neurovascular surgeries (devices used in vessels in the head) using medical devices that help with blood flow where it is blocked.
“More and more, the FDA accepts a device to put on the market but says you need to capture data over time on how [well they work],” says President and CEO Gregory Lange. “It’s really exciting for us.”
M2S, which has 65 employees, has grown about 10 to 15 percent annually over the last several years. Five of those employees were added last year specifically for the registry part of the business, which grew revenue by 70 percent last year.
All that work keeps him very busy, but not too busy for a run. "I probably had at least two business meetings on the run this summer. The way I look at it some people appreciate the game of golf because it's time to spend walking and talking. I don't appreciate golf, but I sure enjoy getting out for a run," he says. Lange runs about 25 miles a week and goes anywhere from 3 to 8 miles most days.
M2S also maintains databases to manage clinical trials and another division of the company converts 2D images into high definition 3D images to help doctors treat high-risk patients (which it has done more than 300,000 times for hospitals worldwide).
“There is so much interest in this area—how do we improve patient care and decrease cost. This is the theme in health care. The place where we feel we can really do well is addressing that question of cost and quality by getting more hospitals engaged in these tools,” says Lange while running down a rural rail trail.
When Lange is not at work he spends time outdoors with his family. He has two children, ages 14 and 11, both of whom are cross country skiiers and runners.
Lange says the FDA oversight is far from the only reason the clinical registry business is doing well. His business has several stakeholders—including hospitals, physicians, insurers, the FDA and device companies—that all have reasons for wanting to know how devices used in vascular and neurovascular surgeries are performing and the performance of surgeons. The registry provides detailed information about the procedures: where they were performed, length of patient stays and outcomes. Data is provided by hospitals. Clients pay a subscription fee to access the data. One item not included that Lange would like to add is follow-up information from the patients about how they are recovering.
He says the registries have captured data from about 25 percent of the market, and he hopes to have 500 to 600 hospitals participating in two to three years. The company is adding a 13th procedure to its registry next year.
To learn more, visit M2S.com.
Current Issue - May 2024