In October 2014, the US Food and Drug Administration (FDA) held a public workshop to gather feedback from the manufacturing and medical device communities with regards to additive manufacturing. The insights from that workshop eventually led to the FDA guidance on Technical Considerations for Additive Manufactured Medical Devices.
There are many unique and vital questions that medical device engineers need to answer with regards to additive manufacturing. While they are not difficult, it is new work compared to traditional applications.
While the 30-page FDA guidance covers a number of important topics such as biocompatibility, software security, and acceptance testing, there are three key areas of risk and where implementation struggles exist that are worth delving deeper into.