Does it seem logical to dress a child in adult clothes or to expect a child to walk in adult sized shoes? No? Well why not? Because we understand that children are not small adults, they require clothing and shoes depending on their size. These are just two of the simplest things in life that children differ greatly compared to adults. This may seem ridiculous, of course we know children are not small adults. So why is it that we are trying to implant adult medical devices in paediatric patients?
This problem is occurring, as there is not enough paediatric specific medical devices being released into the market. The legal and regulatory framework used by the FDA (US Food and Drug Administration) for paediatric medical devices is complex, and economic or market barriers to medical and surgical device development for children are significant (Statement, 2017). Due to the need of paediatric medical and surgical devices, and the challenges to paediatric development, surgeons and clinicians are forced to used adult sized medical and surgical devices in children. They have to jerry rig the adult device by modifying it in terms of placement in the body or by adding accessories to it to make it work with the paediatric patients. This is called off-label use of the device, when an adult device is used in paediatric patients that hasn’t been specifically tested for these patients. Should paediatric practitioners be forced to adapt medical devices studied and approved in adults for use in very different patients?
Many of the “cutting edge” devices are simply translated from adult research and adult studies for use in paediatric medical devices. Companies looking to develop a paediatric medical device are faced with a large hurdle of looking for suitable paediatric subjects for their clinical trials. These clinical trials are required in order to gain FDA approval.
It’s a complex procedure for any device, but for paediatrics there are added complications. Children are generally healthy, but when they are sick, they usually have rare and complex illnesses. There is often a lack of data relating to these illnesses available to product developers, which means larger clinical studies are required to get a product to market. Clinical trials in children are typically more complex and more expensive to run than adult studies. To add to these costs, paediatric devices rarely qualify for pre-market notification, which exempts them from clinical studies, meaning the company must incur further costs and delays in getting their technology to market. Currently, paediatric medical devices are a high risk and low return investment.
At KidMedTech we’re looking at how this problem can be solved, for the paediatric patients, their families, and their doctors. If you are a domain expert in any of the fields discussed above feel free to get in touch, we’d love to hear from you. Can you join us in changing the future for our children?
This blog is written by Fionnuala McCourt and Clara Hynes from the KidMedTech team and edited by Ellen Le Bas. KidMedTech is part of the 2018 UCD Sustainability Launchpad led by UpThink in association with the UCD Energy Institute. If you have any questions about the Launchpad programme just email firstname.lastname@example.org.
November 6, 2018