2019 “Make Your Medical Device Pitch for Kids!” Competition
The unmet need for devices developed for our younger children is predominantly felt by pediatricians, patients, and families. Despite the formidable progress that has been made, still most devices approved for children are studied only in patients ≥18 years old, and by manufacturers who develop these devices primarily for adults. These manufacturers obtain pediatric approval on the basis of study in the older pediatric subpopulation, the adolescents (18-21 years). The testing and approval of high-risk medical devices in pediatric populations <18 years old remains extremely uncommon.
While there are unique challenges involved with pediatric medical devices in general, the off-label use of approved devices is routine in NICU. These devices are often classified as high-risk and subject to the most demanding regulations. And, to add to these complexities, traditional randomized clinical trials are even more difficult to conduct, because assigning children to a control arm when an available off-label alternative---believed to be safe---already exists.
This challenge competition is seeking applications from device innovators that propose a NICU device solution. In addition to monetary awards, awarded companies/labs will have access to clinicians, engineers, and regulatory and reimbursement experts at Children’s National Sheikh Zayed Institute for Pediatric Surgical Innovation and University of Maryland A. J. Clark School of Engineering – and their partners including Biohealth Innovation, MedTech Innovator and Archimedic.
- Clinical significance of the pediatric device
- Quality and feasibility of the technology
- Approach to product development, and likelihood of being marketed successfully
- Project team, environment, and resources
- Potential for additional funding
This funding is intended to promote the commercialization of a medical device for pediatrics. Therefore, your long term funding strategy is of interest to the judges.
Finalists must commit to present in person at the 7th Annual Symposium for Pediatric Device Innovation on September 22 at The Boston Convention Center.
- Deadline Extended: August 19, 2019 midnight PDT
- Finalists announced: September 4, 2019
- Competition + Winners Announced: September 22, 2019
Your application should include the following elements, put into a PDF file
- Project description (maximum 3 pages)
- Description of the unmet need
- Description of the device
- Significant benefit to children
- Approach to regulatory and reimbursement
- Go-to-market plan
- Requested budget (max $25K direct costs)