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Jake Evill’s Cortex is a recyclable plastic exoskeleton that would replace a fiberglass or plaster cast for a broken limb.
Additive Manufacturing
Photo courtesy Jake Evill (3D Exoskeleton)
A Pathway to Approval for Additive-Made Devices
Devices made with additive manufacturing techniques often replace a similar, or predicate, device made in a different manner
Ilene Wolff Contributing Editor A
dditive manufacturing is now producing all manner of medical devices, and new ideas for the process—ranging from printed surgical tools and bone replace- ments to human tissue—are
coming from designers and engineers daily. Even the best idea, though, has little value in the United States unless the Food and Drug Adminis- tration gives its go-ahead for putting the device on the market.