families affected by severe tracheomalacia, they started offering surgical implantation of the splints as a primary intervention to Justice and other patients.
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October 2024Hurdles remain. “One thing we’re working through now is the speed at which we can make this happen,” Dr. Goudy said. “Right now, it takes six to eight weeks, at a minimum, to go through all the hoops, design, 3D print, sterilize, and then implant custom splints.”
Currently, the FDA must still individually consider each case. Full FDA approval of the custom-printed splints is the eventual goal, Dr. Maher said, noting that he, Dr. Goudy, and Dr. Hollister have already met with the FDA to discuss what’s needed to hit that goal and ultimately increase access to customized external airway splints.
Justice is thriving today because physicians and engineers collaborated to create an innovative solution. That kind of creativity and collaboration can help advance the treatment of all kinds of medical conditions.
“As otolaryngologists, we need to continue to tell the story of the unmet needs of our patients,” Dr. Goudy said. “We need to communicate that to engineers and scientists and work alongside them to develop new therapies.”
Jennifer Fink is a freelance medical writer based in Wisconsin.