How can quality systems evolve to realize the potential of 3D printed medical devices?
The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), also known as 3-dimensional printing (3DP).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):