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New Software and Manufacturing Techniques Push Custom Implant Expansion

Design and development is still evolving in the realm of patient-specific implants, though.

“From a technology point of view, we’re trying to cut down on steps and time wasted in the user experience, and trying to add more features to our software to develop more accurate patient-specific implants,” Fox says.

Echoing Fox, Thompson says the production process for custom implants is not without its challenges.

“One of the unique challenges associated with custom implant procedures is establishing an “engineer-to-order” system that manages each patient case through the custom design and manufacturing processes,” Thompson says. “Such systems need to control and coordinate the case data and workflow from start to finish, including facilitating collaboration with physicians to accept initial design input and provide a means for review and approval of proposed custom components.”

iTotal vs._TKR1
ConforMIS knee implants are designed and manufactured to the
patient's specific anatomy to decrease size and fit issues.

Siemens sees additive manufacturing more in use for instrumentation, rather than for the implants themselves.

“Interfaces, usability and automation associated with CAD/CAM technology today make it a lot easier to train and have people do this personalized work,” Thompson says. “The technology has been around for years, so there’s not a lot of risk. There’s an increased level of knowledge and awareness about what that technology can do. For customized instruments, 3D printing has had a big impact—to be able to print these one-of-a-kind shaped instruments that align to patients’ anatomies. These days, it happens without too much difficulty because of internet-based collaboration and relatively low-level cost production from a global supply chain.”

Troy Vanderhoof, Marketing Director of Siemens PLM Software, notes the changes in manufacturing equipment used to produce these parts.

“Machining with high speeds is one of the modern technologies that, in comparison to conventional cutting, enables you to increase efficiency, accuracy and quality of work and at the same time decrease costs and machining time,” he says. “Look at the changes that have taken place in just the last 20 years:

      •    Speed: Maximum feed rates were 100 ipm. Now, 600 ipm is common and 1,200 ipm is better.

      •    Accuracy: Data density of 0.04-inch point departures was close and accurate. Now, closer than 0.004 inch is common and
           may even be closer than 0.001 inch.

      •    Data/CPU: Files of 64 kilobytes were very large. Now, files regularly exceed ten and even 100 megabytes.

      •    Sculptured surfaces were used occasionally for aesthetics. Now, sculptured surfaces are widely used for both
            function and appearance.”


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