Children's Hospitals Today - Summer 2024 - 10

ROUNDS / INNOVATION
From idea to bedside
Pediatric device consortia support the development of medical devices
created specifically for children.
BY CHELSEA ADAMS
M
edical devices engineered for children's
size, growth, body chemistry,
and disease propensity rarely leave the
laboratory. A federal effort to funnel dollars
to pediatric device consortia seeks to
change that trend.
" Children are 25% of the population and
100% of the future, but while so meaningful,
they are a relatively small percentage
of medical patients, " said James Wall, MD,
a pediatric surgeon at Stanford Medicine
Children's Health.
" If you look at publicly available data,
there's been really robust growth in
FDA approvals of devices for adults with
chronic diseases, " Wall said. " Fewer than
five pediatric devices are approved by
the FDA annually that are designed and
tested for the unique needs of children.
That's been steady, and it hasn't grown. "
Wall serves as the principal investigator
of the UCSF-Stanford Pediatric
Device Consortium, one of five such nonprofit
entities that receive Food and Drug
Administration funding to support the
development of pediatricspecific
medical devices.
The consortia provide
regulatory expertise, business
planning guidance,
and device development
services, such as intellectual
property advising,
prototyping, engineering,
laboratory testing, and
grant writing. They also hold competitive
grant competitions to fund entities working
to bring pediatric-focused products
to market.
" A lot of physician entrepreneurs don't
understand the engineering business. A
lot of business entrepreneurs don't have
access to patients or insights into health
care. The consortia help them fill gaps
through mentorship, coaching, and building
development plans, " he said.
Challenges surrounding pediatric
device
development
" KIDS ARE TRULY
AN UNDERREPRESENTED
POPULATION. "
extend
beyond the need for
entrepreneurial acumen.
Limited financial margins
in pediatrics often present
the biggest hurdle.
Wall referenced an
effort at the Stanford
Byers Center for Biodesign
to create a device that
reduced the risk of central line bloodstream
infections in neonates by
preventing umbilical venous catheters
(UVC) from migrating. The domed design
simultaneously ventilated the healing
umbilicus and secured the UVC during
baths, diaper changes, and procedures.
Investors weren't interested. With
a market of roughly 200,000 patients,
SUCCESS STRATEGIES
Consortia are supporting the development of products like these:
BOPPLI, a non-invasive
blood pressure
monitoring device,
helps some patients
avoid arterial lines.
BIOSENSE uses
non-contact electrodes
to prevent putting
adhesive stickers
on children during
electrocardiograms.
FLOWSENSE assesses
hydrocephalus shunt
function externally,
eliminating the need for
imaging studies.
10
CHILDREN'S HOSPITALS TODAY Summer 2024
Children's Hospitals Today - Summer 2024

Table of Contents for the Digital Edition of Children's Hospitals Today - Summer 2024
