The Challenge of Pediatric Device Development

article image

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.


This article is restricted to subscribers only.

Sign in to continue reading.


We're here to help! Please contact us at: