Pediatric Medical Device Development Pathways

For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/j4qxydd5/release/4 The Pediatric Medical Device Safety and Improvement Act (PMDSIA) was passed in 2007 to increase the number of pediatric devices approved by the Food and Drug Administration (FDA). PMDSIA also led to the introduction of the Pediatric Device Consortia grant program, which promotes institutions to pass new pediatric devices. In the past, people relied on nontraditional methods of gaining capital for medical device development. Since the act, pediatric devices have still lagged behind FDA-approved adult medical devices due to various clinical hurdles, including the small market size, which can result in a limited return on investment (ROI), a challenge for private investors.