This paper provides a systematic review of over 350 publications that document specific medical device examples in which the design and manufacturing relied on additive manufacturing processes (more popularly referred to as “3d Printing”). Existing reviews on 3d printing for medical device design focus on the range of clinical applications and potential uses for this technology. However, existing work tends to omit key medical device development and regulatory requirements pertaining to the use of 3d printing for technology translation. These omissions often present a skewed view of each device’s potential for rapid translation to commercialization and common clinical practice.

To fill gaps in existing literature, this review includes medical device journal articles and identifies each article’s country of origin, the product development stage in which 3d printing was used, and the device’s specific type and classification under the U.S. Food and Drug Administration. The findings from this systematic review provide a detailed international snapshot of current additive manufacturing research and its near term potential for changing clinical practice.

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