Five finalists have been named in the prestigious annual “Make Your Medical Device Pitch for Kids!” competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in electrophysiology devices that treat congenital heart disease (CHD) and arrhythmias in pediatric patients, these five finalists now have access to a pediatric accelerator program led by MedTech Innovator and will compete for a share of $150,000 in grant funding from the U.S. Food and Drug Administration (FDA) in the final virtual pitch event in September 2021. The pediatric pitch event is part of the 9th Annual Symposium on Pediatric Device Innovation, co-located with the MedTech Conference, powered by AdvaMed.
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.
"Experts have indicated there is a critical need for pediatric devices to address arrhythmias in children and we are delighted help advance innovations that seek to bridge that care gap,” says 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. "For too long, pediatric innovation has lagged behind that of adults. That’s why NCC-PDI remains committed to identifying and supporting technologies that significantly improve pediatric care and are most viable for clinical use and commercialization.”
The following are the five pediatric device innovations that judges selected for the final competition:
- The Children’s Hospital at Montefiore – New York, NY – PeriTorq, a catheter grip tool for use during pediatric cardiac interventional procedures;
- Inkspace Imaging – Pleasanton, CA – a pediatric cardiac and vascular MRI coil;
- Karios Technologies – Charlottesville, VA – Tissue Shield, a technology to prevent scar tissue formation (adhesions) on the heart after surgery;
- Sibel – Niles, IL – ANNE One, ICU-grade wireless sensors for cardiopulmonary monitoring in neonates with congenital heart defects;
- Starlight Cardiovascular – San Diego, CA – Project Lifeline, a less-invasive way to maintain sufficient circulation in newborns with ductal-dependent circulation that increases safety, procedural success and ease of use.
Beginning in June 2021, the five finalists participate in a pediatric-focused track of the MedTech Innovator accelerator, the world’s largest accelerator of medical devices.
“MedTech Innovator focuses on improving the lives of patients through accelerating the growth of innovative health care solutions,” said Paul Grand, CEO of MedTech Innovator. “We welcome the opportunity to work with this year’s cohort of emerging companies and look forward to providing them with individualized mentorship. Our goal is to help them strategically take the next steps towards product commercialization, as there is an immense need for more medical devices created specifically for children.”
To date, NCC-PDI has mentored over 160 medical device sponsors to help advance their pediatric innovations, with 12 devices having received either their FDA market clearance or CE marking. The accelerator program is the consortium’s latest addition to a network of resources and experts that it provides in support of pediatric innovators.
Eskandanian says supporting the progress of pediatric innovators is a key focus of the new Children’s National Research and Innovation Campus, a first-of-its-kind focused on pediatric health care innovation, with the first phase currently open on 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, as well as on-site incubator Johnson and Johnson Innovation – JLABS, the campus provides a rich ecosystem of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.