Children have medical device needs that are considerably different from adults. Designing devices for children requires considerations such as growth and development, anatomical and physiological differences, hormonal influences, and activity level. The challenges also include small markets, minimal financial incentives, and regulatory issues. Often, the lack of available devices for children forces clinicians to use an adult device off label or to improvise. Off-label use may be the only option, but such use can bring risks of serious adverse events that could be avoided if there were more US Food and Drug Administration (FDA)–approved pediatric devices.1 To address very similar issues related to orphan drugs, the US Congress passed the Orphan Drug Act in 1983 to provide incentives for industry investment in orphan drugs. It was not until 2007 that a somewhat analogous act, the Pediatric Medical Device Safety and Improvement Act, became public law. This Viewpoint suggests that incentives in forms of legislation and availability of grant programs have greatly facilitated the development of orphan drugs. Although there are inherent differences in drug and device development pathways, there are lessons to be learned. The Table illustrates that, in contrast to drugs, there are very few incentives available to stimulate investment in pediatric devices.
Eskandanian K, Klein M, Kim PCW. Lessons From Drugs to DevicesA Pediatric Perspective. JAMA Pediatr. 2015;169(11):989-990. doi:10.1001/jamapediatrics.2015.1932