NCC-PDI is one of five consortia in the FDA’s Pediatric Device Consortia Grant Program created to support the development and commercialization of medical devices for children, which lags significantly behind the progress of adult medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland, with support from partners MedTech Innovator, BioHealth Innovation and design firm Archimedic.
"Children deserve to benefit from our most advanced medical technologies, so we want to encourage the development and design of devices with their unique needs as top of mind," said Kolaleh Eskandanian, Ph.D., M.B.A, P.M.P, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. "Far too few pediatric innovations complete the journey to commercialization, which is why NCC-PDI focuses on identifying and supporting innovations that will make a significant improvement in pediatric care and have a good chance of making it to clinical use.”
The following are the 10 pediatric device innovations that judges selected for the final competition:
- Adipomics Inc. - Cambridge, Mass.; gestational pre-diabetes diagnostic to prevent birth defects
- BioSense - Beverly Hill, Mich.; first working non-contact EKG for constant, non-invasive monitoring
- Dsseca – University of Maryland, College Park, Md.; platform device to rapidly discover biomarker signatures of oxidative stress
- Eclipse Regenesis, Inc. – Menlo Park, Calif.; first restorative therapy for short bowel syndrome (SBS) via distraction enterogenesis
- Innara Health – Olathe, Kan.; biofeedback device to train premature infants and newborns in the neurophysiological aspects of feeding
- Little Sparrows Technologies Inc. – Winchester, Mass.; Portable, high-intensity phototherapy for neonatal jaundice treatment
- Navi Medical Technologies - Melbourne, Australia; provides quick and easy capture of real-time feedback on the location of central lines in neonates without radiation use
- Novonate – South San Francisco; secures and protects the umbilical catheter insertion site for neonates in intensive care
- Renata Medical – Costa Mesa, Calif.; growth stent for treatment of congenital narrowed lesions in neonatal patients
- Spino Modulation, Inc. – Montreal, Canada; anterior vertebral body tethering for adolescent idiopathic scoliosis
Leading up to the October 2020 pitch competition, the 10 finalists are participating in a pediatric-focused track of the MedTech Innovator accelerator, one of the industry's leading nonprofit startup accelerators.
“MedTech Innovator focuses on identifying the most promising medical technology innovations in order to improve the lives of patients,” said Paul Grand, CEO of MedTech Innovator. “We look forward to working with the companies participating in this year’s pediatric accelerator to help them get one step closer to bringing their transformative health solutions to children who need them.”
To date, NCC-PDI has mentored more than 100 medical device sponsors to help advance their pediatric innovations, with seven devices having received either their FDA market clearance or CE marking.
The new accelerator is the consortium’s latest addition to a network of resources and experts that it provides in support of pediatric innovators.
"Delivering solutions for our youngest patients, while supporting innovators and their development, is critical in the quest to improve pediatric health," said William E. Bentley, Ph.D., director of the University of Maryland's Robert E. Fischell Institute for Biomedical Devices. "We're proud to empower our 10 finalists and are excited about the potential of the device submissions in the competition. Together, we can ensure a long-term approach to device innovation with children in focus, from incubation to clinical trials and eventually into production."
In addition to its annual competition, NCC-PDI is currently conducting a special “COVID-19 edition” pediatric medical device competition focused on innovations that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic. The competition will provide up to $250,000 in grant awards and one entrant will be selected by Johnson & Johnson Innovation – JLABS to receive a one-year residency at JLABS @ Washington, D.C., which will be located on the new Children’s National Research and Innovation Campus currently under construction. Submissions are being accepted through July 6 at innovate4kids.org.
Eskandanian said that supporting the progress of pediatric innovators is a key focus of the new first-of-its-kind Children’s National Research and Innovation Campus located on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus in Washington, D.C. With its proximity to federal research institutions and agencies, universities, academic research centers and on-site accelerator Johnson & Johnson Innovation – JLABS, the campus will foster a rich ecosystem of public and private partners which, like the NCC-PDI network, will bolster pediatric medical device innovation and commercialization.