Affiliations: Office of Orphan Products Development, OC, FDA, USA.
Abstract: The development of medical devices for children is probably the next
frontier in scientific and regulatory development. While some pediatric devices
may have a potentially large market share, many do not and this makes them
"orphans" in their own right. Recently the U.S. government has started to pay
new attention to the area of pediatric device development. There are several
challenges to paediatric device development and as, a consequence, it currently
lags 5 to 10 years behind those for adults. Thus, many physicians and surgeons
are forced to adapt adult devices in order to suit their paediatric patients. Challenges in paediatric device development reside in the fact that children
differ from adults not only in terms of their size, but also because they are
growing, so often a static device may not be adequate for a growing child. In
addition, after a few months to years, an infant or child may outgrow a device
and need a new one.