VEPTR: Changing Lives

VEPTR: Changing Lives

Robert M. Campbell, MD: 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.