By Staff Reports
(DGIwire) – 3D printing is revolutionizing the world of medical devices. In May 2016, when the U.S. Food and Drug Administration released new guidelines for medical device manufacturers involved in 3D printing, the agency spotlighted some of the technology’s key advantages. For example, scans of a patient’s body can be used to create 3D-printed components precisely matched to their anatomy rather than relying on off-the-shelf parts, while parts of unprecedented complexity now can be created more easily than ever before.
Economics offers another key advantage. According to a PBS report, a prosthetic arm costs about $40,000; a 3D-printed arm costs a fraction of this, so prosthetics for children—which will quickly be outgrown—make economic sense. Also, creating a 3D-printed limb takes a fraction of the time required otherwise, reports Engineering.com. Meanwhile, dental labs are using 3D printing to make models and aligners, as well as complete removable dentures, according to Dental Economics.
But how do quality inspectors ensure that each new 3D-printed medical device is of the highest quality? Traditionally, this has required an “Edisonian” trial-and-error approach to tweaking the parameters of the process used to manufacture each 3D part.
“Regulatory agencies stressed that medical device manufacturers must be sure they understand the ‘upstream effects’ that different steps in the manufacturing process might have on a device,” says Mark J. Cola, President and CEO of Sigma Labs, Inc. “For example, the ratio of recycled to virgin metal powder can affect melting properties, which affects the energy needed to create consistent bonding between layers, which in turn affects a device’s final mechanical properties.”
In 3D metal printing, a component is built up one microscopic layer at a time out of a metallic powder that is manipulated by a laser; a computer-aided design (CAD) blueprint tells the laser exactly how to shape the material—but finalizing that optimal blueprint can be an arduous process.
Sigma Labs has developed a proprietary, patent-protected, quality assurance software suite called PrintRite3D® that transforms the 3D printing process. In contrast to traditional quality assurance that is performed after-the-fact, PrintRite3D works in real-time to assist quality inspectors in sorting acceptable from suspect components.
The PrintRite3D® suite benefits medical device companies that are 3D-printing metal parts in three aspects. The first involves metallurgy: in addition to optimizing the structure/property/parameter qualities of metal parts, Sigma Labs’ software allows engineers to assess each part’s microstructure—scanning and collecting data on potential weaknesses (like “pores” in the metal). The second benefit involves geometry: the software helps capture images of every layer of metal as it is being incorporated into the part; this data, available digitally, gives inspectors the ability to detect any distortion as parts are made and adjust the machine accordingly in real-time. Finally, the software enhances a company’s productivity by collecting Big Data regarding the performance of multiple 3D printers at multiple locations into a single database.
With a core facility in Santa Fe, NM, Sigma Labs offers clients a comprehensive one-stop shop for 3D metal printing and process engineering; alternately, Sigma Labs can offer its suite to clients at their own facilities.
“It is in the best interest of medical device manufacturers to ensure each device is perfect for the patient it’s intended for, and the in-process quality assurance methodology made possible by our PrintRite3D® technology makes this possible,” adds Cola.