(Image by Yousef Espanioly on Unsplash)
FDA recently reported a startling fact: Most of the pediatric medical devices approved in fiscal 2017 were originally intended for adults.
Health providers, especially in NICUs, are continually altering devices in order to do all they can to save infants and children, but the situation is not ideal, Michael Drues, a regulatory consultant based in Southern California, recently told Medical Design & Outsourcing in its latest podcast. Simply put, children grow; adults don’t.
“Clearly there needs to be more incentives. … But I’d like to put the impetus on industry as well,” Drues said.
Drues suspects the trend toward personalized medicine will help. “Personalized medicine applies to people across the board. Whether they’re 8 days old, or 8 months old, or 8 years old or 80 years old, it doesn’t make any difference.”
Listen to Drues as he outlines some strategies to get a pediatric device to market faster:
It all comes down to diminished return. Sadly the infant market is too small to warrant the kind of investment to achieve real innovation. Until we set aside quarterly profits as the end all and be all, nothing will change. I used to work on pacemakers some designed for babies, and the company wouldn’t even upgrade equipment for existing products due to low profitability.