In Isabella's article in Healthcare Business Today she discusses why, "The Time is Now for Pediatric Device Development to be Centerstage." Isabella reviews the current challenges that exist when innovators design and develop pediatric medical devices.
The FDA is already enacting changes to move the needle of innovation to alleviate these challenges - but awareness needs to be brought to the solutions that exist.
"Vasum Peiris, MD, MPH, FAAP, FACC, FASE, chief medical officer and director of Pediatrics and Special Populations at the FDA Center for Devices and Radiological Health (CDHR), improving the regulatory process for pediatric medical devices is a matter of health equity. He believes the infrastructure exists within children’s hospitals across the nation to support an increase in the development of medical devices, but more emphasis needs to be placed on supporting innovation and regulation that provides equitable device design and development for all populations." - Isabella Schmitt, RAC, Proxima CRO's Director of Regulatory Affairs
Do you know why pediatric devices historically haven't received funding in their earliest stages from a regulatory perspective?