FDA Examines Barriers to Pediatric Technology Development

Posted August 21, 2018

Vasum Peiris, MD, speaks at CDRH pediatric device
Vasum Peiris, MD, chief medical officer of pediatrics and special populations at the Food and Drug Administration Center for Devices and Radiological Health, describes the need for pediatric medical device development during an August 13–14 public meeting.

In many instances, the medical devices available in the pediatric field lag behind their adult counterparts or don’t exist at all, forcing clinicians to use adult devices off-label for children or rely on older technology. To address the issues forestalling pediatric medical device development, the Food and Drug Administration (FDA) convened a public meeting and workshop August 13–14 to delve into the financial, regulatory, and design constraints.

The event bought together approximately 900 registrants, including medical device innovators, regulators, clinicians, venture capitalists, and patient advocacy groups to discuss and evaluate ways to improve the number of pediatric medical devices. The workshop will culminate with a report to Congress in 2019.

“We have a lot to do when it comes to addressing the specific needs of the pediatric populations. There are still far too few devices on the market designed specifically to treat, diagnose, or cure diseases in children,” said FDA Commissioner Scott Gottlieb. “Despite legislation from Congress and regulatory improvements by the Center for Devices and Radiological Health (over the past decade), novel devices designed, evaluated, and approved for pediatrics are only about a quarter of those for adults. And the majority of pediatric approvals are not for children under the age of 18.”

The field of pediatric healthcare technology faces profound challenges to overcoming a smaller market—and therefore less money for development—compared to adult or general-use devices. In addition, pediatric devices have to account for a smaller patient and an ever-changing physiological landscape as the child develops. Despite these obstacles, those who work in the pediatric field are moving into the future guided by an enormous amount of passion, empathy, and ingenuity.

Speaking at the public meeting, Kurt Newman, a pediatric surgeon and CEO of Children’s National Health System, said that it’s time to fire up “a pediatric voice” to for pediatric healthcare technology.

“Children are not being invested in enough, and commercial progress has not kept pace. Although there’s been some change, pediatric medical devices still lag five to 10 years behind advances for adults. We especially see an unmet need for the smallest children, who are two to 10 years old,” he said. “For too long, pediatric clinicians have had to become accustomed to improvising adult medical devices for children … Children need tailor-made technology.”

Children’s National is one of several pediatric healthcare systems working directly with healthcare technology innovators to encourage pediatric medical device development. It is a member of the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), which holds a national pediatric medical device competition in conjunction with a symposium on pediatric innovation. NCC-PDI receives funding from the FDA through its pediatric device consortia grant and the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National.

A need exists for spurring development of devices that are specifically designed, evaluated, and approved for children, according to Vasum Peiris, MD, chief medical officer of pediatrics and special populations at FDA CDRH, who led the public meeting and recently spoke to AAMI in a cover story published in the July/August issue of BI&T.

“Generally, whether a device is intended for an adult or a child, we evaluate a spectrum of scientific evidence and consider the benefit-risk profile for each device and the population that it’s intended to serve,” said Peiris. “That being said, we have several programs in place intended to help promote pediatric medical device development.”

The FDA’s efforts to encourage pediatric medical device development have included issuing guidance on the types of information necessary when developing devices for children, appropriate protections for children, and options for leveraging clinical data for extrapolation to pediatric uses of medical devices, as well as adapting general use devices so they work for a pediatric population. The FDA also has programs to help address pediatric device development challenges, such as the humanitarian device exemption approval process and the pediatric device consortia program.

Read more about this issue, including the role of healthcare technology professionals in improving the pediatric healthcare experience, in the July/August issue of BI&T at www.aami.org/PedsTech.