When a medical device company is working in the same market space as players like Stryker and Olympus, securing U.S. Food and Drug Administration clearance is only half the battle.
Solon, Ohio-based medical device company Thermedx has the FDA clearance in place as well as several local customers and is now embarking on the mission of establishing a presence outside of its home state.
Thermedx makes a fluid management system to help surgeons avoid complications associated with irrigation fluids, which are used in millions of gynecology, urology, orthopedic and other surgeries every year to distend body cavities or clear away blood and debris.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A gynecology surgeon, for example, may distend a woman’s uterine cavity during a hysteroscopy to improve his ability to see during the procedure. But to prevent perioperative hypothermia, the liquid used for distention would traditionally be heated in some kind of warming device before being delivered. This device combines that step and others to streamline the process.
“This is the only FDA-cleared device that can pressurize, warm, deliver and measure the irrigation fluid in one device,” said Executive Vice President Mike Haritakis.
Cleared by the FDA in 2010, the device hit the market in early 2011 and has since made its way into some of Northeast Ohio’s big hospital chains. Although its primary target market is gynecology, it’s also used in some urology and orthopedic procedures.
The goal for 2013, Haritakis said, is to transform Thermedx from a regional company to a national company. It’s working toward a deal with a national sales organization to expand its footprint. Having recently worked with the Austen BioInnovation Institute to secure Canadian regulatory clearance for the device in gynecology, urology and other surgeries, Thermedx is also in talks with a Canadian distributor.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Fueling that kind of growth will require another big undertaking: fundraising. The company is working with regional financial services company Acquire Wealth Advisory and other fundraising groups, including Carleton McKenna & Company, to raise $5 million of growth capital in the coming year.
Haritakis said Thermedx has a product road map that leverages platform technology used in the fluid management system, but will for now remain focused primarily on expanding sales of its lead device.
Founded in 2007 by Haritakis and CEO Douglas Carr, Thermedx now has 18 full- and part-time employees.
