Sometimes Downsizing is Good

Originally Published MPMN May 2005

EDITOR'S PAGE

Sometimes Downsizing is Good

What’s good for the goose is good for the gander, but it’s not always good for the goslings. Yes, kids are people, too, but they are very different from adults. Especially when it comes to medical devices. Since most medical devices are designed for adults, pediatricians often have to adjust grown up–sized products to fit children’s smaller bodies and special needs.

If that’s all doctors had to do to treat their patients, it would be a nuisance, but not a huge problem. But it’s not that simple. Children are different from adults in other ways. For example, they often have a faster heartbeat and respiratory rate. In general, they are more active than adults. And they are still growing, which means that an implanted device must be flexible enough to grow with them, or be easily adjusted as the child matures.

Pediatricians are becoming increasingly frustrated by the lack of products for their patients. The American Pediatric Society & Society for Pediatric Research (APSSPR) says that although great strides have been made to improve drugs for children, devices lag far behind.

According to APSSPR, having to use inappropriately designed devices may result in increased risk during procedures. For example, during endoscopy, the use of an adult-sized scope may cause tissue damage and pain. There may also be a greater need for sedation because more-invasive procedures have to be used when the alternative noninvasive device is not sized for children.

“There’s an ethical responsibility to ensure that we have safe and effective devices for use in children,” says Jon Abramson, pediatric chairman at Wake Forest University.

No reasonable person can argue with that. So why aren’t there more devices designed and manufactured specifically for the pediatric population?

FDA tackled this question not too long ago and came up with some interesting conclusions. The agency submitted a report to Congress last October regarding its attempts to find out why there aren’t more pediatric devices. FDA sought comment from many sources, including medical device manufacturers, in preparing the document.

One of the report’s conclusions is that there should be enhanced communication between pediatric clinicians and device manufacturers. This will help identify the most pressing pediatric device needs, promote discussion of feasible modifications to existing adult devices, and generate ideas for new pediatric devices. The agency proposes workshops and roundtable discussions to get the ball rolling.

This is a great opportunity. Pediatricians are well aware of their patients’ needs. The opportunity for manufacturers to hear what is needed from them firsthand is invaluable.

The APSSPR says that this type of information sharing could help the manufacturer identify a market for a new or modified product. It can also promote collaboration among product designers and pediatricians or institutions in the modification or creation of new devices.

This is a much-needed first step toward better pediatric healthcare, and well worth the effort on everyone’s part. After all, it’s for the kids.

Susan Wallace, Managing Editor

Copyright ©2005 Medical Product Manufacturing News