A newly published article in Pediatric Research, “ A national strategic framework for developing medical devices for children,” outlines the first coordinated national strategy designed specifically to increase the availability, safety and effectiveness of pediatric medical devices. Jonathan M. Davis, MD, Newborn Medicine at Tufts Medical Center, Professor of Pediatrics at Tufts University School of Medicine and a leader in the Tufts Clinical and Translational Science Institute (CTSI), is a senior author of the paper and a core member of the SHIP-MD Consortium behind the framework.
A critical need
Today, most medical devices used in children were originally designed for adults. That means young patients, especially infants and children with complex conditions, often rely on modified or “off-label” devices that may not fully meet their needs. Economic barriers, regulatory complexity and the challenges of conducting pediatric clinical research have slowed innovation in this space for decades.
A blueprint for change
The SHIP-MD framework proposes coordinated action across five priority areas to strengthen pediatric device development nationally:
- Finance: New funding models that make it more feasible to develop devices for smaller pediatric populations.
- Hospitals: Characteristics and infrastructure hospitals need to support pediatric device innovation and safely generate clinical evidence.
- Navigation: A structured pathway to guide innovators from early concept through evidence generation, regulatory review and adoption.
- Regulation: Enhancements to existing FDA pathways to better support devices intended for children.
- Reimbursement: Aligning coding, coverage and payment processes to help bring new devices to market and into clinical use.
This multi-stakeholder approach unites federal agencies, clinicians, hospitals, industry and patient advocates and is designed to ensure that safe and effective pediatric devices reach patients more quickly and consistently.
Tufts Medicine is a leader in neonatal and pediatric research, with particular strength in clinical trials and device evaluation. Dr. Davis’s work within SHIP-MD reflects a commitment to advancing care for children and partnering across sectors to drive innovation.
“Improving how we develop medical devices for children isn’t just a scientific challenge—it’s essential to providing the best care,” said Dr. Davis. “Children deserve technologies designed for them. This framework helps make that possible.”
