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Challenges with Pediatric Medical Devices

August 14, 2019

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

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




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Some highlights of this episode 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.



Premarket Approval (PMA)

Premarket Approvals (PMA) Database

Humanitarian Device Exemption (HDE) Regulation: Questions and Answers

Pediatric Device Consortia Grants Program

Orphan Drug Designation: Disease Considerations

Saybie: World's tiniest baby

Mike Drues

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru


Memorable Quotes From This Episode:

“The market size for most medical devices, as well as drugs, is much more common on the adult side.” Mike Drues

“Smaller, shorter versions of (adult) products is not really solving the problem.” Jon Speer

“There’s just not a lot of financial incentives for companies to develop medical devices or drugs for kids.” Mike Drues

“Unfortunate realty: Medicine is a business, in every sense.” Mike Drues



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...