Consolidating 3D Printing Tool Chains to Mitigate Risk in Medical Device Applications
By J Thompson – Use of 3D Printing technology to create medical devices has been widely publicized over the past several years. Most of these stories illustrate the unique ability for 3D Printing (aka Additive Manufacturing / AM) technology to produce highly complex organic shapes.
Despite past success with AM, and very promising growth opportunities, there are significant risks with the current AM practices for workflows in device design and manufacturing. These risks must be recognized and addressed by device makers to fully realize the potential of AM, and avoid failure modes inherent in current practices.
Today, the biggest risks are caused by software “tool chains” in which different, specialized software applications are used sequentially to yield finished devices. A fundamental problem with serial tool chains is rework. What happens when you get off the “happy path”, and issues are discovered in the fourth, fifth, or tenth tool in the chain, and resolution requires a change in the first or second tool in the chain? That typically means serially reworking the entire workflow from the point of change.
This kind of rework should be viewed as expected, normal, necessary, commonplace, and even desirable since it theoretically leads to an improved final result. However, as AM attempts to enter an “industrial” stage of maturity, there are several risks associated a serial tool chain, especially if rework is manual and requires experts to re-do knowledge-intensive rework. more>