The Global Medical Device Podcast Episode 115 Challenges with Pediatric Medical Devices is an honest discussion addressing medical devices for children and pediatric hospitals set inside the marketplace.
This episode was refreshing to hear calls for medical devices designed specifically for children. The voices of experience shared longstanding vendors cannot simply ‘retrofit’ a device for young kids.
As mentioned there is quite a difference in treating small children with devices designed for adults. Mike Drues of Vascular Sciences and Jon Speer discuss the lack of availability for such medical devices and prescription drugs, specifically with children in mind.
Simply manufacturing a “smaller version” of adult medical devices and drugs for pediatric populations may not be the best solution. Lack of availability is simply due to a lack of market.
I found this to be a very interested issue discussed on the podcast: 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 the industry or the FDA get companies to focus on life-sustaining/life-saving devices and drugs for pediatric market? The answer points to clinical trials, informed consent, and 3D printing.
While most medical products are required to show safety and efficacy, The US Food and Drug Administration’s Humanitarian Device Exemption (HDE) only requires a probable benefit.
This podcast episode was enjoyable, educational and should serve as inspiration to medical device vendors and the FDA as they strive to discover how the medical device market can more accurately target and design medical devices for children.
How many adult trauma centers deploy special precautions to ensure young children have safeguards when needing medical devices? For a Children’s Hospital it should be rather amazing to consider that a clear majority of medical devices deployed are actually designed for adults.
It reminded me of young children learning how to ride a bike with training wheels versus handing them a bike ridden in the Tour de France.