The medical device industry is adopting 3-D printing for several applications. But what are the best uses for this type of technology today? The best 3-D printing medical device applications include external wearable devices, clinical study devices, and orthopedic implants.
External wearable devices are suited for 3-D printing because they are usually customized to fit each individual. This devices are attached to the outside of the patient and can be made much larger or thicker than surgical devices or implants. Biocompatibility requirements can be evaluated by ISO 10993-1. These devices fall within the “surface device” category with skin contact limited to unbreached skin. The amount of experimental testing needed depends on the biocompatibility information available for the materials used and the ones used in the fabrication processes. Initiatives like the Biocompatibility Consortium for Additive Manufacturing are underway to help create standards for assessing and validating 3-D printing processes.
Clinical study devices are suited for 3-D printing as well, where build quantities are low and design changes after evaluation are likely. “For a device with multiple components, 3-D printing offers a cost effective way to create clinically usable parts without the cost ($10,000–$30,000+) and development time (4–8+ weeks) of injection mold tools.”
Orthopedics and dental are another type of area where 3-D printing found excellent adoption. A key performance aspect of orthopedic implants is fixation in the bone. The benefits with additive manufacturing are that the effective porosity and the thickness of the ingrowth area can be controlled throughout the build and the manufacturing completed all in one process.