Challenges continue with the design and development of pediatric medical devices.

In this episode, Mike Drues of Vascular Sciences, and I discuss the lack of availability for such devices and prescription drugs, specifically with children in mind.

Some of the highlights of the show include:
●Smaller versions of adult medical devices and drugs for pediatric population may not be the best solution or solve the problem.
●Lack of availability is due to lack of market. Drugs approved by the FDA for adults are relabeled for kids.
●Two-thirds of all drugs prescribed to children have not been studied or labeled specifically for them, and 90% of the drugs given to newborns are off-label.
●Physicians modify and improvise: Technical challenges include designing and developing pediatric-specific products that change and grow as the child does.
●How can industry get companies to focus on life-sustaining/life-saving devices and drugs for pediatric market? Clinical trials, informed consent, and 3D printing.
●Most medical products are required to show safety and efficacy; HDE only requires probable benefit.
●Real world evidence needed to support pediatric medical device submissions.
●Necessity is the Mother of Invention: Doctors retrofitted breathing tube for Saybie, a micro preemie the size of an apple.