3-D Printed Implants Hit The Market, Pave The Way For More Personalized Devices
This article was originally published in The Gray Sheet
Companies have recently started to launch implants constructed via 3-D printing to increase product customization and to save on costs. FDA says the additive manufacturing techniques are a promising form of personalized medicine.
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A top FDA device official says the agency is hoping to finalize an additive manufacturing guidance this year. Industry is particularly interested in seeing the leap-frog guidance made final, but would also like to see more clarification and a separate guidance to address the topic of patient-specific manufacturing.
A draft guidance issued by FDA on additive manufacturing, or 3-D printing, of medical devices is meant to be a starting point for an industry that is growing exponentially. The document outlines recommendations on topics such as device design, software considerations and material testing requirements.
Medical device manufacturers have a growing interest in 3D printing, a technology that could upend the manufacturing and distribution of certain medical devices and expand the scope of personalized medicine – especially in orthopedics, where it's used for some models, implants, and surgical cutting guides.