Left behind by adult technology, kids are just starting to get right-sized devices.
There is no such thing as a baby pacemaker. Or a defibrillator for kids.
For children with an irregular heartbeat, the only option is an adult device. Pacemakers are wedged into children’s abdomens because there isn’t enough room in their chests. As their bodies grow, they face years of surgeries as the adult devices are replaced or modified.
The wave of medical device innovation that is improving and extending the lives of younger generations is passing over the youngest. While more patients in their 30s, 40s and 50s are benefiting from an extensive range of treatments, products are rarely developed with children in mind. Doctors must routinely alter devices to fit into kids’ bodies or wait until they are older to provide treatment.
“The biggest challenge, by far, is size,” said Dr. Christopher Carter, a pediatric cardiologist at Children’s Hospitals and Clinics of Minnesota. “But there are other issues as they get older: They aren’t going to be able to play contact sports. … Really, it becomes a lifetime of compromise.”
The scarcity of specialty devices for kids is largely a numbers game: There aren’t enough children with chronic illnesses to justify the cost of developing products just for them. Since most devices are developed in the private sector, companies such as St. Jude Medical and Medtronic spend their time on products that reach a broader population and ultimately return a profit.
“It can cost $100 million to bring a device to market,” said Dr. Steve Oesterle, Medtronic’s senior vice president for medicine and technology. “The market [for kids] just isn’t big enough.”
Children are noticeably absent from the development of treatments for pain, movement disorders and heart ailments — treatments that are helping tens of thousands in other age groups.
An estimated 1,600 children ages 1 through 17 in the United States had a procedure involving a pacemaker or a defibrillator in 2010, according to data from the U.S. Department of Health and Human Services. That compares with 56,033 patients ages 45 through 64 and 155,446 ages 65 through 84.
Kids also make up just a fraction of those receiving orthopedic treatments. Only 200 children had a procedure involving artificial hips in 2010; 188 received knee replacements.
Yet doctors and advocates say there are several technologies they are trying to develop with children in mind — and a few already are coming to market. Among them are defibrillators that don’t use wires to connect to the heart and tracheal tubes that won’t damage a baby’s esophagus during some procedures.
Such specialty devices also could prove more durable and efficient because they are a better fit. A smaller pacemaker, for instance, could further improve heart function in young children and be better secured in their bodies.
“The need is for a whole variety of low-tech and higher-tech devices that are optimized for kids,” said Donald Lombardi, who runs the Institute for Pediatric Innovation in Massachusetts. “It’s not rocket science to develop these things. But it takes good engineering — and an overall market.”
A group at the University of Michigan is trying to develop products aimed at kids. So are others at the University of California, San Francisco; Stanford University; and Atlanta Children’s Hospital.
All have won grants through the Office of Orphan Products Development, a program through the U.S. Food and Drug Administration (FDA) that seeks to nurture the development of medical products for patient populations of fewer than 200,000.
But most new devices, if they ever make it to market, are years away.
“It takes a lot of dedicated people and continuing to think outside the box to make things happen,” Lombardi said.
Little kids, big devices