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>> I'm Dr. Robert Campbell, a pediatric orthopedic surgeon
and inventor and the father of five children.
Throughout my career, I cared for children in need
of medical technology that was not readily available to them.
But the primary reason I was invited to appear for you today
is I both invented, developed, and brought to market
a life-saving pediatric surgical device known as
the vertical expandable prosthetic titanium rib,
also known as VEPTR.
This was approved as a Humanitarian Device
Exemption device in 2004 after 14 years of FDA trials.
I am here to help provide you with some insight from
someone who's been in the trenches about how this
pending legislation can help the children who need devices.
Children deserve access to devices that are safe,
effective, and made just for them.
But they are frequently denied access because there
is a relatively small market for pediatric devices
with little incentive for manufacturers to make them.
We physicians must commonly jury-rig existing devices
for children.
The VEPTR was invented to replace such a jury-rigged
device that had been used to save the life
of a 6-month-old, full-time ventilator dependent infant
born with scoliosis and missing ribs.
I made many mistakes in developing VEPTR.
I had no experience in device development
or knowledge of FDA requirements.
I had no mentor.
But learning through trial and error over the years,
supported by grants from the National Organization
of Rare Disorders, and the Orphan Products Division
of the FDA, and, luckily, identifying child advocate
manufacturers, we've succeeded after 16 long years.
Many hundreds of pediatric devices,
however, have never been developed and probably won't
be under current conditions.
The children deserve better.