Report: Boom In 3D-Printed Medical Devices By 2022
This article was originally published in The Gray Sheet
A new market report estimates the global health-care revenue from 3D-printed medical devices is likely to grow to almost $3 billion by 2022. FDA has a keen interest in understanding how to oversee production of 3D-printed devices that can be made anywhere, and device-makers are interested in the technology to develop products personalized to patients.
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As industry awaits more guidance and clarification from US FDA about its regulatory oversight of 3D-printed devices, the agency is attempting to be more transparent with a new web page that outlines some of its current thinking and efforts on the topic.
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.
The Oct. 8-9 workshop will serve as a forum for FDA to collect public input on technical assessments that should be considered for 3-D printed devices to “provide a transparent evaluation process for future submissions.”