JMIR Publications

ABSTRACT

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 were not intended for or tested in children. Several barriers have been identified that pose difficulties in bringing pediatric medical devices to market. These include 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 created the Pediatric Device Consortia Grant Program (PDC) under the administration of the Office of Orphan Products Development. In 2018, the FDA awarded over $30 million to 5 new PDCs. The West Coast Consortium For Technology & Innovation in Pediatrics (CTIP) is one of these PDCs and is based at Children’s Hospital Los Angeles. In February 2019, CTIP convened its primary stakeholders to discuss its priorities and activities for the new grant cycle. What follows is a report of the summit proceedings, shared here in order 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.