AAP brings need for pediatric medical devices to forefront
MelissaJenco, News Content Editor
As development of medical and surgical devices for children continues to lag, pediatricians,
manufacturers and regulators are coming together to look for new solutions.
They proposed incentivizing manufacturers, streamlining the regulatory process, looking
for new funding sources and more during a two-day meeting the Food and Drug Administration
(FDA) held at the Academy’s urging.
“Off-label use of medical devices in children continues to be a necessary and appropriate
but unfortunate reality for pediatricians and pediatric surgical specialists,” said
AAP CEO/Executive Vice President (Interim) Mark D. Del Monte, J.D. “Our goal must
be to significantly decrease the off-label use of devices in children so that children
are … using devices designed for them and studied in pediatric populations.”
However, unlike pharmaceuticals, companies are not required to study medical devices
in children, and development continues to lag behind devices for adults. Over the
past decade, only about 9% of devices going through pre-market approval or humanitarian
device exemption pathways were approved with pediatric indications for children under
18, , according to data presented by the FDA.
Pediatric device development poses numerous challenges. Adhering to regulations to
get products approved can be timely and costly. The small number of children with
certain conditions makes it difficult to perform studies and commercialize devices.
If investors don’t believe they will get a sufficient return, they won’t provide the
funding to get these projects off the ground.
“A large gap still exists between the idea and the clinical application for pediatric
devices, mostly due to the significant development and regulatory costs with insignificant
financial return,” said Bob Kroslowitz, president and CEO of Berlin Heart Inc. and
representative of AdvaMed, a trade association for the medical technology industry.
Throughout the meeting, experts discussed ways to optimize evidence generation through
randomized controlled trials, extrapolation of adult data and use of real-world data.
The issues of marketability and funding generated discussion about involving venture
capitalists in future talks, looking at other funding sources like philanthropic organizations
and patient advocacy groups, offering incentives to manufacturers and improving insurance
coverage. Some suggested using an orphan drug model, which incentivizes development
of drugs for rare conditions. Others called for more money for Pediatric Device Consortia
that assist with these projects.
To overcome regulatory hurdles, some suggested adding more pediatric experts to FDA
review teams, allowing expedited review and looking at ways to streamline the process
without sacrificing quality or safety.
FDA Commissioner Scott Gottlieb, M.D., said the agency has been adding pediatric experts
to advisory panels, collecting data on unmet needs and barriers, finding new ways
to protect children in trials and incorporating real-world strategies to generate
evidence. He committed to doing more.
“Today, more than ever, we recognize the unique needs of children and we’re working
to encourage the development of safe, effective medical devices specifically for pediatric
patients,” Dr. Gottlieb said. “… There are still far too few devices on the market
designed specifically to treat, diagnose and cure disease in children.”