Medical- device innovators don't just jump through hoops to bring their products to market — they jump through multiple hoops for several years.
That was the view shared by product designers and marketers at the recent Plastics in Medical Devices conference hosted by Plastics News, from June 12-13 in Westlake.
Future Path Medical Holding Co. is going through the innovation process firsthand. Later this year, the Concord, Ohio-based firm will commercialize its first product, eight years after the project began.
The company's product is the UroSense-brand urine monitoring system, a sensor placed in a urine bag that's designed to prevent spills and other problems experienced by patients. UroSense uses a Mylar-brand polyester backing on a PET or PVC container.
Future Path CEO Brian Gilbert said the idea came from Chris Bryant, a quadriplegic Ohio resident, and his family. Urine bags present numerous challenges for paralyzed individuals, Gilbert said. And in hospital settings, nurses can spend as much as an hour per shift measuring and charting and emptying urine bags.
“It's an amazingly backward system,” Gilbert said.
Future Path adviser Claire Zangerle — who serves as president and CEO of the Visiting Nurse Association of Ohio in Cleveland — added that “if you take away from patient care, you take away from the outcome.”
The UroSense product can check fill levels and flow rates, and then wirelessly transmit that data to a nurses' station. It's far less expensive than some existing bedside sonar systems, Gilbert said.
But the lengthy road to commercialization included three to four years of testing and three years spent acquiring Food and Drug Administration approval. The testing period included research with focus groups and with staff in intensive-care units at 60 hospitals.
Gilbert said Future Path had to make sure its patent for UroSense could be protected, but he added that the project “was more difficult from a lab perspective than we expected.”
Future Path also benefited from a bit of luck when UroSense fell under an existing code in Medicare billing, sparing the firm from trying to create a separate code. “We had to be able to make [UroSense] at a certain price point and be profitable and reimbursable,” Gilbert said.
Ease of use also was important. “Complicated things are not attractive to the user,” Zangerle said. “If a product is too complicated or the nurse doesn't embrace it, it won't be successful.”
Medical-device veteran Kevin Harper had a similar experience recently on a smaller scale when dealing with sealing issues on a surgical device called a trocar, which is used in abdominal procedures. The plastic seal on the device was tearing, so Harper's firm — Knowvention LLC of Mason, Ohio — had to find a way to address the tearing while allowing surgeons to retain fine control of the instrument.
Harper and his colleagues at first tried to solve the problem through lubrication, but they eventually realized they had to redesign the device. This led to a multiweek project that included 19 design iterations, two prototype tools and a cost of almost $65,000. The end result worked, however, winning approval of almost 80 percent of surgeons who used the device.
“Innovation means different things to different-sized companies,” Harper said.
“Different stakeholders also have different values. So you have to ask the right questions,” he added.