3D printing brings unique considerations for medical device engineers. But when used well, FDA’s additive manufacturing guidance can give you a competitive advantage.
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.
Multiple file-format choices exist, but you might want to consider taking additional steps when saving your parts for 3D printing.
I remember when I was planning my first 3D printer purchase. These were endless hours of browsing phrases like “3D printer choice criteria” or “the most important 3D printer details/parts”.Almost every article’s main point was “it depends on what do you want your 3D printer to be used for”.And this is obviously true. Of course, I know that this is not what you are looking for, so in this article I would like to introduce you to a list of the seven most-important features of 3D printers which you need to look at before buying a new one of your own.
You know when a product comes out and we think it’s awesome? Then years later, something comes out to replace it, and we look back at the first thing like, “What a pile.” Well, I’m almost to that point vis-à-vis 3D printers, even though there’s nothing to replace them.