While there are unique challenges involved with pediatric medical devices in general, the off-label use of approved devices is routine in pediatric cardiovascular care. These devices are often classified as high-risk and subject to the most demanding regulations. Congenital heart disease, for example, is twisted with variability in anatomic complexity, physiology, and acuity. 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 cardiac or vascular device solution that will also be tested in pediatric patients <18 years old. 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 Johnson & Johnson and Smithwise. In addition, the awardees will benefit from facilitated engagement in the I-ACT network (Institute for Advancement in Clinical Trials in Pediatrics).

Criteria

• 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.

Funding support provided by: Children’s Hospital Foundation
Mentoring and coaching support:

• Children’s National Medical Center
• University of Maryland
• I-ACT
• Smithwise
• Johnson & Johnson