How can medical device makers assess the FDA implications of 3D printing?

Adhering to FDA regulations on the manufacture of medical devices might be simpler when it’s more complicated.

That is to say: When manufacturers work in the traditional mode of large-scale, industrial production, they know the rules and are prepared to work under them. But what about when the manufacturing process becomes simpler – as in the case of 3D printing? How do the rules apply to that new frontier?

3D printing, or additive manufacturing (AM), offers device makers a range of potential advantages. They can be more innovative in design, address needs in a more customized way, and deliver products directly at the point of use. AM opens the door to offerings that would previously have been cost-inefficient because of scale.

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FDA issues draft technical guidance for additive manufactured devices

How can quality systems evolve to realize the potential of 3D printed medical devices?

3D printer

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), also known as 3-dimensional printing (3DP). AM is a process of joining materials to make objects from 3D model data, usually layer upon layer, as opposed to subtractive manufacturing methodologies 1. “The process begins with a 3D model of the object, usually created by computer-aided design (CAD) software or a scan of an existing product.  Specialized software slices this model into cross-sectional layers, creating a computer file that is sent to the AM machine.  The AM machine then creates the object by adding layers of material on top of each other until the physical object is created.

Companies pursuing AM capabilities choose between divergent paths (figure below):

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