The pediatric patient population has been historically underserved by medtech companies, in part because designing and commercializing a pediatric device presents a host of unique issues. The Boston Pediatric Device Strategic Partner Challenge was created to help develop novel pediatric device ideas. By Bridget Shaia & Andrew Millar, Health Advances
In fiscal year 2016, the US FDA approved a total of 71 premarket approval (PMA) applications and humanitarian device exemption (HDE) applications. Of these 71 approvals, 13 were indicated for use in a pediatric population or subpopulation, only two of which were intended solely for pediatric use.