A national strategic framework for developing medical devices for children

Area of Science:

• Pediatric Medical Device Innovation
• Public-Private Partnerships in Healthcare

Background:

• Less than a quarter of new medical devices are developed and approved specifically for children, creating a significant unmet therapeutic need.
• Pediatric device development faces challenges including economic disincentives, ethical concerns, and lack of advocacy.

Purpose of the Study:

• To introduce the System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD) framework, a multidisciplinary initiative to enhance pediatric medical device quantity and quality.
• To address the long-standing public health issue of limited treatment options for children through a national, actionable approach.

Main Methods:

• The SHIP-MD framework focuses on five priority areas: finance, hospital criteria, navigation, regulation, and reimbursement.
• It involves key participants from both private and public sectors to foster collaboration and streamline processes.
• Operationalizing a national approach through feasible and actionable steps.

Main Results:

• The SHIP-MD framework is designed to improve the development and approval of medical devices for pediatric populations.
• It aims to harmonize regulatory and reimbursement processes, optimize funding, and expedite unique coding for better coverage.
• The framework is deemed feasible and actionable, with steps underway for national implementation.

Conclusions:

• The SHIP-MD framework offers a viable path forward to address critical challenges in pediatric device development.
• Leveraging public-private partnerships is key to driving innovation and improving access to essential medical devices for children.
• Operationalization of the SHIP-MD framework is expected to significantly enhance pediatric healthcare.