Additive Manufacturing
“The Cortex exoskeletal cast provides a highly technical and trauma zone localized support system that is fully ven- tilated, super light, shower friendly, hygienic, recyclable and stylish,” Evill wrote on his website. To make Cortex, a patient would be X-rayed and 3D scanned. Then computer-aided design would calculate the device’s pattern for support in the area of the bone break, and an algorithm would be used to 3D print the device. Evill was an industrial design student in New Zealand when he created Cortex. The James Dyson Foundation, estab- lished by the creator of the Dyson vacuum cleaner, thought so highly of Evill’s idea that it named him runner-up in its 2013 design engineering competition. Attorney Lawrence said of Evill’s device: “That being out- side the body it’s more akin to an arm sling or an orthopedic brace. I have a hard time believing it wouldn’t be similar to a predicate device.”
2-in-1 Devices
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DeFelice and Evill aren’t the only ones making news with their devices. Two years ago, Dr. Scott Hollister, professor of biomedical and mechanical engineering and associate professor of sur- gery at the University of Michigan, used 3D printing to make a life-saving device for a baby.
“FDA reviewers are wary of ‘predicate creep,’ where submissions veer further and further away from something that’s been approved.”
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Kaiba Gionfriddo, a 3-year-old from Ohio, passed the two-year survival mark in February after receiving an emer- gency experimental splint to keep his trachea open. Kaiba has severe tracheobronchomalacia, a rare condition that causes the airway to routinely collapse. To make the splint, doctors at U-M CT scanned the affected area of Kaiba’s respiratory tract, and used the images to design and print the tube-shaped splint to help keep the area open. When a pediatric otolaryngologist implanted it, Kaiba’s lungs immediately started moving on their own in the operating room. Unlike the skull prosthesis or broken limb exoskeleton, though, Kaiba’s splint is expected to dissolve in his body as his airway naturally matures. That’s because it’s made of polycaprolactone, or PCL.
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ManufacturingEngineeringMedia.com | April 2014
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