Challenges with Pediatric Medical Devices - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2019-11-07T15:06:53
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.
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