SEVERAL CARDIAC DEVICES — pacemakers, heart valves and stents — got their start with children.
In the 1950s and ’60s, before FDA oversight, the first devices were used in an effort to save young heart patients before the technology was expanded to a broader population.
“Why is that? Because no one wants to see a kid die. I believe kids are the catalysts for imagination,” Medtronic’s Oesterle said.
But the way devices are developed has changed dramatically since then. In 1976, the FDA was given the responsibility of approving medical devices, which increased oversight. Where doctors once conducted research in backroom labs and tested devices with parents’ consent, the FDA now requires extensive testing and clinical trials for new devices.
Convincing device makers to do that for a costly product that might only help a handful of children is a nearly impossible sell, said Dr. Robert Campbell, a pediatric orthopedic surgeon and director of the Center for Thoracic Insufficiency Syndrome at the Children’s Hospital of Philadelphia.
Campbell has developed products for children, including a spine device that can be adjusted as a child grows, but it took 14 years to get it to market.
“I was very lucky,” he said. “I had a company that was owned privately and an owner that was very sympathetic to children.”
The two main areas of device adaptation for children are cardiovascular and orthopedic, said Brad Slaker, founder of DesignWise Medical, a Minnesota company that facilitates development of pediatric devices. Slaker calls those segments “low-hanging fruit” with moneymaking possibilities.
Otherwise, companies are reluctant to develop lifesaving or life-sustaining pediatric devices because they require expensive human testing. So potential pediatric devices, such as diabetes monitors for children, lack the profit margins that spur commercial research and development.
Slaker started DesignWise Medical to adapt adult devices for use in children and then to find corporate partners to mass produce and sell them. His company is working on a product called an “OPOD” that morphed an adult oxygen mask into a hood to treat children who need help breathing, but cannot tolerate a mask.
Child-specific medical devices also pose ethical issues. Researchers often struggle to find large enough pools of youngsters to make clinical trials statistically significant. Most parents are reluctant to volunteer their kids as guinea pigs in studies that could be necessary for better device evaluation.
For that reason, the FDA is working on new ways to derive pediatric uses from adult clinical trials, although nothing has happened yet.
“We’re trying to put out the word to industry about circumstances where we could take adult data and extrapolate it to the pediatric population to try to encourage … labeling products for pediatric use,” said Christy Foreman, director of the FDA’s Office of Device Evaluation.
A lifetime of choices
SOMETIMES, THE BIGGEST hurdle for young people with medical devices is learning how to live with them.
Katie Kobelinski, 29, is a nurse who works with younger heart patients at the Midwest Adult Congenital Cardiac Center in Minneapolis. It’s where adults with heart problems who were once youngsters with heart problems learn how to live a life filled with medication, battery changes and lifestyle modifications.
Most patients she sees are in their 20s, 30s and 40s. Her job is to persuade patients not to miss appointments or to skip medications — and to live within limitations.