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.
