A national strategic framework for developing medical devices for children.

Despite widespread and urgent therapeutic need, less than a quarter of new medical devices are developed and approved specifically for children, leaving this growing population with limited treatment options. The System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD) framework is an initiative involving many key participants from both the private and public sectors which was developed to address this challenge. SHIP-MD is a multidisciplinary effort with a primary aim to improve the quantity and quality of medical devices that are specifically indicated for use in pediatric populations. The program centers on five priority areas: 1) finance (organizational and operating models; device development funding), 2) hospitals (criteria that hospitals must satisfy in order to participate), 3) navigation (on-boarding of innovators, coordination and management of evidence generation), 4) regulation (refining and optimizing current regulatory processes, recommending new regulatory options), and 5) reimbursement (harmonizing regulatory/reimbursement processes, expediting unique coding to optimize reimbursement, enhancing payments/coverage). SHIP-MD represents a path forward to addressing a long-standing public health matter. The developed framework is feasible and actionable with steps presently being taken to operationalize this national approach. IMPACT: Pediatric device development faces significant challenges including economic disincentives, ethical concerns, and absence of robust advocacy. Potential solutions involve leveraging public-private partnerships to drive innovation. The System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD) is an initiative involving the private and public sectors which was conceived to address these multiple challenges and represents an important path forward. The developed framework is feasible and actionable with steps presently being taken to operationalize this national approach. Less than a quarter of new medical devices are developed and authorized specifically for children. Pediatric device development faces significant challenges such as complex funding/reimbursement models and regulatory frameworks. Potential solutions involve leveraging unique public-private partnerships which have been proposed through the System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD) framework.