System of Hospitals for Innovations in Pediatrics-Medical Devices

System of Hospitals for Innovations in Pediatrics-Medical Devices (SHIP-MD)

The pediatric medical device sector confronts a significant challenge characterized by limited participation and innovation, impeding the development and market access of essential medical devices for children. Innovators encounter numerous barriers upon entering this market, including insufficient return on investment, limited market access, regulatory complexity, lack of guaranteed reimbursement, and low development incentives.

The SHIP-MD initiative is a collaborative endeavor among government agencies, private entities, and non-profit organizations, including the Harvard-MIT Center for Regulatory Science. The initiative aims to overcome these barriers by establishing a national ecosystem to streamline the evaluation, approval, and reimbursement for pediatric medical devices. Currently in its design phase, the project seeks to establish governance structures, integrate existing expertise and resources, and formulate a comprehensive strategy for launching a multi-year public-private partnership. For a more in-depth review of this project, visit the FNIH page here. 

This video provides a high-level overview of SHIP-MD: