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Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities

May 9, 2022

Blog: Family Connections with Pediatrics

Most of us have heard or used the phrase: kids are not little adults. This could not be truer when it comes to medical devices. Ever seen a 6-year-old using an adult-sized wheelchair? It almost swallows them up. Can you imagine how well an adult-sized heart valve, tracheotomy tube or feeding tube would work in the body of an 8-year-old? Unfortunately, adult devices are often re-purposed and used in a way not intended for children.

What exactly is a medical device?

The United States Food & Drug Administration (FDA) defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article…which is not dependent upon being metabolized for the achievement of its primary intended purpose.” Simply put, it is a medical device, a tool or machine for example that is used for medical reasons. There are more than 1,700 types of devices, ranging from thermometers to mechanical heart valves to MRI machines.

This month in Pediatrics, Espinoza et al (10.1542/peds.2021-053390) published, “Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities” that gives a summary of the medical device scene, describes hurdles to pediatric device progress, and offers current ways to help jump these hurdles.

How are medical devices developed?

Making medical devices is big business. There are a lot of companies around the world doing it. While there are some big name companies that make devices, 80% of medical device companies have fewer than 50 employees and generate no sales revenue. Many of these companies begin in a simple way: find an unmet medical need and work hard to create an idea and option.

How are medical devices regulated?

In 1976 Congress gave the FDA the power to review all medical devices. The FDA organizes devices in categories of risk (“class 1-3” rates lowest to highest risk); as the chance of risk to the patient increases, the safety and regulatory controls increase. The class of a device guides the amount of review needed and the steps to register, clear, and approve a device. Sometimes a device can receive a special designation that allows it to move through the process differently. For example, a device for a very rare condition that will help fewer than 8,000 children a year may not be able to get as much data from testing so a “humanitarian designation” helps the device move forward with less testing.

How are medical devices for children different?

The article states that some studies show that advances in devices for children are at least 10 years behind devices for adults. Only about one quarter of medical devices designed, reviewed, and approved are for children. The FDA defines children as up to age 21, and most of the devices designed “for children” are for those aged 18-21.

The authors talk about some of the ways that designing, testing, and paying for devices for children are different, such as:

  • Clinical concerns: Children do not experience life (disease, move, play, grow) in the same way as adults, so devices need to meet their bodies.
  • Technical concerns: Size (mini versions can be harder to make, do not work, or do not grow with the child) and length of use.
  • Monitoring and ethics concerns: It can be hard to test, get data, label, and have reviewers with pediatric expertise.
  • Financial concerns: There is a smaller market for devices for children, and less funding to research and design.

What can be done to create more medical devices for children?

This is the million-dollar question! The authors of the article highlight ways to increase funding to create and study devices for children and also give examples of laws, organizations, and groups of providers and/or businesses joining together for change.

What can you do with this article?

  1. If your child uses devices in their daily medical care, read this article to understand more about how their devices were created.
  2. If your child has an unmet medical need that you think a device might help, consider taking this article to your child’s doctor. You have likely talked before about, “… if we could just create this device, then….”, maybe the article will spark creative thinking. The article gives great examples of ways people are jumping over hurdles to design more medical devices for children. One way is to connect with the American Academy of Pediatrics:
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