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Pediatric medical devices cover a broad array of indications and risk profiles, and have helped to reduce disease burden and improve quality of life for numerous children. However, many of the devices used in pediatrics are not intended for or tested on children. Several barriers have been identified that pose difficulties in bringing pediatric medical devices to the market. These include a small market and small sample size; unique design considerations; regulatory complexities; lack of infrastructure for research, development, and evaluation; and low return on investment. In 2007, the Food and Drug Administration (FDA) created the Pediatric Device Consortia (PDC) Grants Program under the administration of the Office of Orphan Products Development. In 2018, the FDA awarded over US $30 million to five new PDCs. The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) is one of these PDCs and is centered at the Children’s Hospital Los Angeles. In February 2019, CTIP convened its primary stakeholders to discuss its priorities and activities for the new grant cycle. In this paper, we have presented a report of the summit proceedings to raise awareness and advocate for patients and pediatric medical device innovators as well as to inform the activities and priorities of other organizations and agencies engaged in pediatric medical device development. (JMIR Biomed Eng 2020;5(1):e17467) doi: 10.2196/17467

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Innovation in Pediatric Medical Devices: Proceedings From The West Coast Consortium for Technology &amp; Innovation in Pediatrics 2019 Annual Stakeholder Summit