Metal Additive implementation into production in Medical devices



Material testing and its evaluation is the key in development of any component that goes into a medical device. Medical device manufacturing industries are highly regulated and calls for a lot of evaluation due to their impact on human life. Some of the components of these devices revolve around the patient carrying high G-forces. Hence becomes critical to assess the material properties for its variability in terms of powder re-use cycles, effect of powder manufacturers, effect of machines etc., on the component level behavior. This study provides detailed assessment of the powder, machine, build parameters, and re-use cycle effects on the part that gets printed using additive technologies which eventually goes into a medical device. Hence the test study and evaluation are done with detailed study. Future scope also includes rigorous inspection methodology involving other tests like fatigue, load-cycle, vibration, and classical shock wave test etc. As a part of the study, test coupons were printed with two different types of Additive machines in DMLM, employing Selective Laser Melting (SLM) technology using SS-316L metal powder, supplied independently by 2 different types of powder manufacturers. Later, these metal powders were recycled in respective machines to explore the benefits of manufacturing, and cost reduction to promote resource sustainability. The powder was cycled up to eleven times for its re-use. A systematic study was also done to evaluate the characteristics of recycled powder with SEM/ microstructures analysis and its correlation with mechanical properties.

Principal Engineer – CT Scan Engineering
GE Healthcare