Children who are exclusively tube-fed often require the venting of gas from their stomachs in order to improve the distribution of fluids, nutrition and medication. Venting also makes children more comfortable, because removing excess air from the stomach relieves fullness and bloating, as well as pain, discomfort or reflux associated with feeds. Current solutions exist, but none is fully effective at venting while feeding in the pediatric population. Through a bit of nursing grit, a Children's Hospital of Philadelphia (CHOP) nurse practitioner came up with a makeshift solution using available materials, such as syringes and tubing, and implemented it at CHOP. It soon became clear that the prototype might have great potential as an actual product that could be used in hospitals worldwide.
CHOP’s Office of Entrepreneurship & Innovation (OEI) runs a Call for Ideas every year to seek out CHOP innovation and research that has the potential to impact pediatric healthcare through further internal development and commercialization, working closely with the Office of Technology Transfer (OTT). It was through our 2018 SPRINT (now Sprout) Call for Ideas that OEI met Judith J. Stellar, MSN, CRNP, CWOCN, the wound ostomy nurse practitioner who conceived of the venting innovation. She came to OEI with an impressive pitch deck, outlining the clinical unmet need, her research, the current standard of care and, of course, the rough prototype she had created herself. “This was clearly an unmet need,” says Stellar. “I wanted to develop an efficient venting device that would work for children of all ages and also be available and easy to use for both the inpatient and home settings.”
After OEI reviewed 65 idea applications, Stellar’s project was selected to be in the small cohort of 2018 SPRINT finalists. The initial phase of the project explored creating a “proof of concept” prototype. Stellar and the OEI team worked with a local Philadelphia design firm that OEI has collaborated with extensively over the years. The design process began with a wide array of potential configurations and features, eventually landing on a suitable prototype. From there, Stellar gathered extensive feedback from real clinical users at CHOP, culminating in the final design of what she named the Vent and Feed.
The next phase of OEI’s process involves a market assessment and business value proposition in order to attract the interest of an industry partner for commercialization through CHOP’s OTT. OEI expanded upon Stellar’s original pitch deck to clearly explain the unmet clinical need that the device would fulfill and worked with the design firm to build a more refined protype to present in a pitch to a potential industry partner.
After ensuring the appropriate intellectual property protections were in place, Stellar and the CHOP team had an initial meeting with the company to pitch the idea. Stellar explained and demonstrated how her prototype worked and its advantages over other products currently available to address the same problem. The company was impressed by the concept and began discussions with OTT on how they could formalize working with CHOP to license the intellectual property to commercialize the product. After putting an agreement in place, CHOP and the company came up with ways to further validate the concept.
During the course of the collaboration, the company presented a counter design, prompting a head-to-head matchup between the CHOP prototype and theirs. More than 100 staff members, including nurses, advanced practice providers and physicians in various divisions, gave feedback. The result was a resounding preference for the original CHOP Vent and Feed design.
With the finalized design in hand, OTT was then ready to negotiate and enter into a license agreement with the company so that they could commercialize the CHOP intellectual property, with CHOP and Stellar, as the inventor, receiving a small percentage of royalty consideration on sales of the product. It was an ideal outcome for a project that took several years of collaborative efforts between offices at CHOP and the industry partner. CHOP will continue to provide feedback as the product goes through the process in which the U.S. Food & Drug Administrations approves the device for clinical use.
Throughout the validation phase with the industry partner, Stellar received support from various nursing departments as well as CHOP’s Center for Simulation, Advanced Education and Innovation, where experts simulate real-world situations to improve pediatric healthcare quality worldwide. All the input helped to shape the Vent and Feed device into the best it can be for caregivers and patients. While medical innovation can be hard and long, at CHOP innovation is built into the DNA of the entire organization. The clinical team showed what creative thinking looks like and how it can potentially lead to an improved standard of care for patients both at CHOP and beyond.