Episode Thumbnail
Episode 115  |  30:59 min

Challenges with Pediatric Medical Devices

Episode 115  |  30:59 min  |  11.07.2019

Challenges with Pediatric Medical Devices

00:00
00:00
This is a podcast episode titled, Challenges with Pediatric Medical Devices. The summary for this episode is: 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.
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.

More Episodes

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis

Understanding FDA's New Intended Use Rule and its Implications