MDDI_Medical Device & Diagnostic Industry

MDDI, June 2014

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MD + DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY JUNE 2014 | 43 performance as a molded plastic, for exam- ple. In fact, the mechanical performance of a 3-D printed part can be from 15% to 80% lower than that of a molded part. 3-D Printing Solutions Bernal says the challenge of creating pro- duction-equivalent 3-D printed prototypes will gradually be overcome as 3-D printing becomes a final production method. To bridge the gap between prototyping and production, a big push is being made to develop USP-certified materials, some of which are already on the market. For sintering machines, materials such such as titanium, chromium cobalt, and PEEK are already being used to produce end-use implantable devices. Closely associated with the issue of materials and the drive to blur the distinction between prototypes and manufactured products is the problem of resolution. "There are some 3-D printing processes with resolutions down in the 10 μm range, but most have resolutions in the 100 μm range," Vicari says. "Depending on the prototype, resolution can pose a limitation, especially if you have curved or sloped edges or other complex structures." But improvements are on the horizon, he adds. "Improvements in resolution and the quality of materials are enabling manufacturers to produce prototypes that are getting closer to end parts and becoming more functional." In addition, 3-D printing is developing better ways of producing and manipulating digital models for prototypes, leading to improvements in the design process. Digital models, according to Vicari, are improving primarily thanks to software advances. Depending on the device, designers either build CAD models from scratch or generate customized files from patient scans. But manipulating such files and using them to produce custom parts requires engineering knowledge and experience with CAD software—skills that not everyone in the medical device field has. One of the promises of 3-D printing is that it will provide more broadly available access to part design and production. Current CAD software interfaces are an obstacle to achieving this goal. "Consequently, a few companies here and there are trying to develop more- intuitive software tools, some of which are based on virtual reality interfaces and some of which merely try to constrain the design options to guide developers along the design path," Vicari says. "As a result, preset design-rule categories are being developed within which the designer can work. This is a trend that we're just start- ing to see." — Bob Michaels 2 The most important obstacle to expanding the use of 3-D printing in the medical device sector is the dearth of suitable materials. Unique. 888.239.3940 Made in the USA since 1960. Kent Elastomer, much like the trees in the Dancing Forest of Kaliningrad, is unique. We are the only manufacturer of natural rubber latex tubing in the U.S. But that's not all that makes us different. We produce medical and surgical tubing to your exacting specifications for diameter, thickness, color and length. Material offerings include latex, TPE, PVC and custom compounds along with assembly and packaging capabilities to meet your requirements. Supported by a degree of quality, knowledge and turnaround time seldom found elsewhere. Do business with us and we know you'll agree. Kent Elastomer is a rare find. Discover Kent Elastomer. We're uniquely flexible. T U B I N G ES450991_MD1406_043.pgs 06.03.2014 02:42 UBM black yellow magenta cyan

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