A local plastic surgeon is working to gain U.S. Food and Drug Administration clearance for a medical device he hopes will alter long-established surgical procedures.
Dr. David Zachary "Zach" Martin developed a product that can automate the initial incision and final closure processes during surgery. His wife and business partner, Aimee Martin, said the concept for the device came about because he thought there had to be a better way to accomplish those tasks in a surgery, which have "essentially been done the same way by surgeons forever."
After working on developing and patenting the device for about four years, the Martins founded the startup BondTrue LLC in 2016 to try and move it to market. Aimee Martin said they are now finalizing their first product and working to get through the testing phases necessary for FDA clearance.
Martin said she and her husband have self-funded much of the development of BondTrue. They also received about $200,000 from the Maryland Industrial Partnerships Program, which allows companies to collaborate with researchers from state universities. The startup is also looking to raise about $2 million in funding to support commercialization efforts, including making hires and ramping up marketing, as well as the FDA clearance process.
Martin explained the BondTrue device helps a medical professional to align the scalpel directly on the skin at the perfect angle for incision, then realigns the skin exactly where the incision was made for the closure after the surgery. Hopefully, Martin said, this kind of device can make some of the basic elements of a surgery more efficient and ultimately help reduce costly surgical time and risk of complications. The automated device could also allow a lower-skilled medical professional to perform the incision and closure tasks, so surgeons can save time and move onto other procedures, she said.
Such a device could have applications in traditional operating rooms, as well as in military settings or in robotics-assisted surgeries, Martin said.
The Martins are working with engineers at the University of Maryland, College Park to develop their BondTrue prototype. By end of the year, they hope to have a finalized device ready for use in clinical trials.
BondTrue has also been accepted into the Maryland Technology Development Corp.'s mdPACE program as it works to expedite the FDA approval process. The TEDCO initiative, which is also funded by a U.S. Department of Commerce grant, is aimed at helping companies get their medical devices FDA cleared within 18 months.
Ultimately, Martin said they would like to be able to sell the BondTrue product to some larger independent medical firm, but at this point it's "hard to tell when or how things will end." She hopes BondTrue will be the first of many products she and her husband can bring to market together.
"This is not the only device Zach has invented," she said. "He's always working on something in the garage."
Dr. Martin named this first device for his mother — Bond is her maiden name — who is a retired physician. Aimee Martin said he wanted to honor her by putting her name on a product that could be used to help save patients' lives for years to come.