Contest Opens to Stimulate Pediatric Device Innovations

Competition for startups aims to increase the pace of development and commercialization of critically needed pediatric medical devices.

In the world of innovation, devices used for pediatric medical care, particularly the very young, are lagging behind those created for adult purposes. A contest is now open, inviting innovators to do something about it. Top contenders will be awarded with support from an innovation accelerator to further develop their device and an opportunity to win up to $250,000 in grant money.

Applications for the contest, operated by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, are due by February 15. The competition focuses on pediatric devices in three areas of critical need: Cardiovascular, orthopedic and spine, and neonatal intensive care unit (NICU).

“While there is a great need for pediatric devices in many specialty areas, the development and commercialization process is very challenging because of the small market size and dynamic characteristics of the patient population,” says Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI, in a news release.

On average over the past decade, only 24% of life-saving medical devices approved by the Food and Drug Administration (FDA)—that go through premarket approval (PMA) and humanitarian device exemption (HDE) regulatory pathways—have an indication for pediatric use, according to NCC-PDI. Of those, most are designated for children age 12 or older.

“Devices designed specifically for the younger pediatric population are vitally needed and, at this early stage of the intervention, can significantly improve developmental outcomes for a child,” Eskandanian says.

The goal of the competition is to increase the pace of development and commercialization of critically needed pediatric medical devices for the benefit of children everywhere, according to NCC-PDI. The application process begins today and concludes in October:

• After the February 15 submission deadline, startups selected for the qualifying round will participate in a pitch session in Washington, D.C., on March 23.
   
• 10 winners will be announced in late May and will advance to participate in the Pediatric Accelerator program with MedTech Innovator, which provides a customized curriculum and in-depth mentorship.
   
• The program will culminate with “Make Your Medical Device Pitch for Kids,” a competition for $250,000 in prizes on October 4 in Toronto at the 8th Annual Pediatric Device Innovation Symposium.

“To provide pediatric innovators with greater support in meeting these unique challenges, we must go beyond grant funding, which is why we are collaborating with MedTech Innovator to offer an accelerator program with a pediatric track,” says Eskandanian.

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. Additional consortium members include Medtech Innovator and BioHealth Innovation, along with  design firm partner Archimedic. NCC-PDI is one of five FDA-funded nonprofit pediatric device consortia focused on facilitating the development, production, and distribution of pediatric medical devices.

To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, says Eskandanian, with six devices having received either FDA market clearance or CE marking (certification for medical devices in the European Economic Area).