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Proceedings from the 2025 Midwest Pediatric Device Consortium showcase featuring software as a medical device
Nina Echelmeyer1, McKay Noll1, Animesh Tandon2
1The Midwest Pediatric Device Consortium, Nationwide Children's Hospital, Columbus, OH, 43215, USA.
BMC Proceedings
|May 11, 2026
Summary
The Midwest Pediatric Device Consortium
Area of Science:
- Biomedical Engineering
- Health Policy
- Medical Device Innovation
Background:
- Pediatric medical device development faces unique challenges.
- Stakeholder collaboration is crucial for advancing pediatric healthcare technology.
Purpose of the Study:
- To summarize proceedings from the Midwest Pediatric Device Consortium's second showcase.
- To identify key challenges and opportunities in pediatric medical device development.
Main Methods:
- Descriptive summary of a meeting convening clinicians, engineers, regulators, entrepreneurs, and policymakers.
- Synthesis of themes from expert panel discussions on value demonstration, post-market surveillance, cybersecurity, AI, and pediatric considerations.
- Analysis of a pitch competition focused on Software as a Medical Device.
Main Results:
- Persistent structural barriers in pediatric device development were identified.
- Key themes included aligning stakeholder value, real-world evidence infrastructure limitations, data security concerns, and AI complexities.
- Software as a Medical Device innovations were highlighted.
Conclusions:
- Addressing structural barriers is essential for effective pediatric medical device innovation.
- Cross-disciplinary collaboration and policy engagement are vital for overcoming development hurdles.
- Future efforts should focus on improving value alignment, evidence generation, and secure AI implementation in pediatric devices.
Keywords:
Food and drug administrationInnovationMidwest pediatric device consortiumSaMDSoftware as a medical deviceMore Related Videos
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