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.