A New Approach to Pediatric Devices
Medical devices are designed and tested for adults. But children's bodies are different, and many adult devices don't work as well, or at all, on children. How to use devices in children is a problem that has vexed medical device manufacturers and caregivers for decades.
Up until now, the options for pediatric-use devices were not great. Either a device company could run expensive pediatric studies, or it could do nothing but sit back and watch hospital personnel improvise ways to use their products on children. So, a firm had to be either fully invested in a costly process that may not produce results, or it could do nothing and be vulnerable to potential misuse and abuse of its products. If there were a systematic way to retrofit devices for children, that might cut down on misuse and allow for more input by device companies.
Now, there might be. In June, as reported on MD&DI's blog, a nonprofit organization was launched to tackle those issues. Among the goals of the Institute for Pediatric Innovation is to work with children's hospitals to redesign devices to better fit children. The institute is based in Cambridge, MA, and its first three hospital partners are based in California, Kansas, and Ohio. As the institute's projects get launched, it will be important for device manufacturers to become familiar with them. As time goes on, it is likely that getting more actively involved with these projects will benefit industry.
Also, the Institute for Pediatric Innovation and similar nonprofits stand to benefit from language in the version of the FDA Revitalization Act passed by a House of Representatives subcommittee last month. Congress would give such organizations $6 million per year for the next five years. It would also provide the device industry with something already in place for the drug industry: patent extensions in exchange for performing pediatric studies. Finally, it would allow device companies to price such devices high enough to make a profit, provided volume was 4000 per year or fewer.
These are badly needed incentives that could give device manufacturers more reasons to design pediatric devices or study the performance of their devices in children. The first step that industry should take is to lobby to ensure that such language remains in the version of the bill that ultimately gets passed.
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