Standardization of 3-D printing technology is still an ongoing process, but the development of technology-specific standards will facilitate its adoption in the medical device industry.
Much ink has been spilled about the virtues of 3-D printing. At the same time, all experts (and fans) acknowledge that the technology still has a long row to hoe before the medical device industry can adopt it fully. At MD&M East on June 11, Peter Mercelis, director applied technologies, healthcare at 3D Systems (Heverlee, Belgium), will address 3-D printing issues in a presentation focusing on “New Technology, Materials Science, and Metallurgy in 3-D Metal Printing.”
“Today, metal printing is already being applied in a large variety of medical device applications, ranging from patient-specific orthopedic and craniomaxillofacial implants to instrumentation and mass-produced spinal and orthopedics implants,” Mercelis remarks. “The technology has the potential to improve the functionality of medical devices because it offers unlimited design freedom.”
What should manufacturers expect from 3-D printing? For one thing, the ability to perform orthopedic applications, Mercelis replies. For example, porous bone scaffolds can be designed and produced, allowing optimal osseointegration of patient-matched designs and standard components alike. Moreover, the technology’s fully digital capability, the absence of tooling, and its ability to produce different designs and sizes in parallel can facilitate new medical device manufacturing business models, leading to faster development cycles, mass customization, reduced inventory costs, and even distributed manufacturing models.
A 3-D printed jaw implant.
Many metal alloys commonly used in medical device manufacturing applications are also available for use in direct metal printing applications. For implants, manufacturers can use pure titanium grades such as CP1 and CP2, titanium alloys such as Ti6AL4V ELI, and cobalt-chrome alloys. These materials exhibit very similar mechanical properties in direct metal printing processes as they do in such traditional manufacturing methods as casting, forging, and CNC machining processes. And in some cases they even offer better mechanical properties. For niche applications, manufacuters can turn to more-exotic materials such as tantalum. And to 3-D print instrumentation, stainless steel alloys such as Type 316L and Type 17-4 are commonly used.
“A user of direct metal printing manufactures not only the shape of an implant or instrument but also the raw material itself,” Mercelis explains. “This increases the manufacturer’s level of responsibility and mandates strict process validation and controls to ensure consistent material properties.” However, because 3-D printing technology is still being standardized, manufacturers continue to rely on existing standards from other domains, such as casting and forging, to prove 3-D printing’s mechanical and physical performance capabilities. However, the development of technology-specific standards will further facilitate the adoption of 3-D printing in the medical device industry, Mercelis adds.
“Obviously, 3-D printing imposes new challenges on medical device companies, regulatory agencies, hospitals, and surgeons,” Mercelis says. “But it may also provide big advantages for both manufacturers and patients.”
Bob Michaels is senior technical editor at UBM Canon.