Standard parts that are too complex or too expensive to be built by other production techniques.

Now, “standard” 3D printed medical devices are responsibly use of high risk designs through rapid prototyping with 3D printing.

They can test new medical devices on realistic medical models to quickly gather clinically relevant performance feedback, without scheduling expensive animal/cadaver surrogate testing.

The guidance defines AM as “a process that builds an object by sequentially building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly produce alternative designs without the need for retooling, and to create complex devices built as a single piece.”

This manufacturing process is used extensively in the aerospace, architecture, consumer products, and, more recently, medical industries.