ICU device for fecal management finds industrial partner

By John Battiston

What started as an idea during a night shift at a VCU Health intensive care unit is well on its way to hitting the medical device market.

Skil-Care Corp. is working with the VCU College of Engineering's Casey Grey, Ph.D., to move a fecal management system flow positioning device he co-developed toward commercialization. The device, originally conceived by former VCU Health ICU nurse Emma Necessary, is now undergoing small-batch clinical testing at VCU Medical Center.

"It's nice to have a partner who has played this game for a long time," said Grey, a postdoctoral research associate who helped Necessary translate the original bedside concept into a functional prototype. "The consistent quality of Skil-Care's products has made us more confident about the results of the clinical trials, which Skil-Care also helped facilitate."

The FMS device, shaped like a wedge, does more than help patients sit up in bed, which can keep their lungs open and reduce pressure injuries. It also incorporates a nonstick channel that supports the role of gravity in waste elimination. The channel can eliminate backflow as well as leaks while protecting a patient's skin from caustic fluids.

For VCU TechTransfer and Ventures, the collaboration reflects its core mission: identifying promising university innovations and pairing them with industry partners capable of bringing them to market at scale.

"What's unique about this positioning wedge is that it was developed literally at the bedside," said Thomasine Isler, innovation and industry engagement manager at TechTransfer and Ventures, a division of the VCU Office of the Vice President for Research and Innovation.

After Necessary shared her idea, it was Isler's job to vet and develop intellectual property around the technology, then find an industry partner to help take it to market.

That search led Isler to Skil-Care, a nearly 50-year-old, family-owned medical products company based outside New York City. Known for its focus on patient safety and comfort, the company maintains domestic manufacturing capabilities that allow for rapid design iteration.

"Our ethos has always been to collaborate with clinicians who are on the front line of health care, whose patients have very specific needs," said Jonathan Treber, CEO of Skil-Care. "The FMS device is one of dozens of examples of this - probably even hundreds - that we've worked on since Day One."

Skil-Care's experience in patient-positioning products made it a natural fit for the FMS device. The innovation is designed to position patients in a way that reduces tubing kinks, leaks and backflow, which are persistent challenges that can lead to discomfort and infection.

"It was a great combination of patient safety and patient comfort, which is at the crux of our mission as a business," Treber said. "It solved an incredibly simple but very important need."

After licensing discussions began, Skil-Care worked closely with VCU collaborators to refine the design through multiple iterations, responding directly to clinical feedback from ICU staff.

"We're trying to find the best of both worlds: protecting the patient and making it easier for caregivers to install, remove and configure the device," said John DeVito, Skil-Care's chief operating officer.

As the small-batch clinical study continues at VCU, Grey, Skil-Care and TechTransfer and Ventures are working in parallel to finalize design, licensing and manufacturing details. Isler notes the contrast between this and other, more transactional industry partnerships.

"Our work with Skil-Care is different - this is a true back-and-forth," she said. "That's what we want our internal researchers to see: If they have an idea, we're here to help them find the right industry partners to move it forward."

She continued, "Even if you're not sure your work is 'ready,' let's have the conversation. Industry partnerships often start with a simple discussion, and those conversations can ignite long-term relationships that amplify your research and expand its reach."

Treber agreed with Isler's summary of their collaboration on this product: "This is the first of hopefully many."