Proceedings from the 2025 Midwest Pediatric Device Consortium showcase featuring software as a medical device

On July 9, 2025, the Midwest Pediatric Device Consortium hosted its second showcase at the MidTown Collaboration Center in Cleveland, OH. This meeting convened clinicians, engineers, regulators, entrepreneurs, and policy stakeholders to discuss the challenges and opportunities in pediatric medical device development. The program included expert panel discussions addressing value demonstration in healthcare, data-driven post market surveillance, cybersecurity risk and data protection, artificial intelligence, clinical algorithms, and pediatric-specific considerations. This culminated in a pitch competition focused on Software as a Medical Device. This manuscript provides a descriptive summary of the meeting proceedings and synthesizes themes that emerged from panel discussions. The themes underscored the persistent structural barriers in pediatric device development, including alignment of value across stakeholders, limitations of real-world evidence infrastructure, data security challenges, and complexities in artificial intelligence driven technologies. These proceedings are intended to inform clinicians, innovators, and policymakers engaged in pediatric medical device development rather than serve as a formal program evaluation.