RESEARCH, PUBLICATIONS & GRANTS
Research
Pediatric medical devices are scarce, often forcing clinicians to rely on adult devices used off-label. As one of five FDA-funded Pediatric Device Consortia in the U.S., we work to identify and address the clinical, technical, regulatory, ethical and financial barriers that limit pediatric device development.
As data and software become integral to medical devices, applying rigorous informatics principles is essential. We bridge informatics and device development by focusing on integration, interoperability, data standards, ontologies and FAIR data principles.
Real-world evidence (RWE) is increasingly critical to post-market medical device surveillance. Thus, we are developing the Pediatric Device Patient Database – the first prospective database integrating clinical, device, and patient-generated health data, which will support both retrospective and prospective research for investigators, industry, and the FDA.
Grants
Awards we’ve received to advance our work
CTIP Publications
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Priorities in Planning Pediatric Medical Device Countermeasures
FDA-Regulated AI-Enabled Medical Devices with Pediatric Indications
Medical Device Design Flaws and Needs for Children with Medical Complexity at Home
Describing Inconsistencies in Pediatric Labeling of Medical Devices
A National Strategic Framework for Developing Medical Devices for Children
Improving the Infrastructure for Pediatric Medical Device Trials at Children's Hospitals
Barriers To and Facilitators of Pediatric Medical Device Innovation: A Scoping Review Protocol
Characteristics and Results Reporting of Pediatric Medical Device Studies, 2017-2022
A Novel Maturity Index for Assessing Medical Device Startups
Pediatric Medical Device Development & Regulation: Current State, Barriers, & Opportunities
The Scarcity of Approved Pediatric High-Risk Medical Devices
Innovation in Pediatric Medical Devices: Proceedings From the 2019 Annual CTIP Stakeholder Summit
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2025 iCoDE Report: EHR Integration Standards & Recommendations for Insulin Delivery Data
iCoDE-2 September 18, 2025 Steering Committee Final Meeting Summary Report
2022 iCoDE Report: CGM-EHR Integration Standards & Recommendations
Use of Continuous Glucose Monitors by People Without Diabetes: An Idea Whose Time Has Come?
Continuous Glucose Monitors & Automated Insulin Dosing Systems in the Hospital Consensus Guideline
Pediatric Device Consortia (PDC) Publications
Publications from our colleagues at other PDCs
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FDA's Pediatric Device Consortia: National Program Fosters Pediatric Medical Device Development
Pediatric Medical Device Development by Surgeons Via Capstone Engineering Design Programs
Strengthening the Evidence Base for Pediatric Medical Devices Using Real-World Data
Advances In Extracorporeal Membrane Oxygenator Design for Artificial Placenta Technology
Advancing Pediatric Medical Device Development Via Non-Dilutive NIH SBIR/STTR Grant Funding
Portfolio Member Publications
Publications supporting the science behind the powerful technologies developed by CTIP portfolio members