David Ryan, Medicrea James Thompson, Siemens Shane Fox, Within Technologies
OEMs and suppliers see promise in the ability of new technology to expand the use of custom implants and bring greater personalization to orthopaedics.
Custom implants and instruments are not new; for years, they’ve been tailored to meet the patient’s specific anatomy with the potential to reduce surgery complications and improve the implants’ success rate. This seems like an obvious benefit to patients and manufacturers. However, more long-term clinical data is needed to prove that custom implants result in better patient outcomes than use of traditional implants. The cost-benefit must also be demonstrated in order for custom implants and custom instrumentation to fully penetrate the market.
“Ultimately, the answer lies in continued and better understanding of the patient benefits,” says James Thompson, Director of Medical Device and Pharmaceutical Industries within Siemens PLM Software. “That’s really where the boundary is today and will continue to be for the foreseeable future. It’s a relatively small percentage of the overall surgeries performed. Whether that grows to be the majority will depend on proven patient benefits, as well as the cost benefits.”
The hang-up for orthopaedic device companies has been and continues to be the ability to maintain volume, cost and speed to market when individual design, manufacturing and shipping processes are concerned. New software and manufacturing techniques have made it easier for some orthopaedic OEMs to adopt a custom implant model.
Custom implants can be produced using traditional manufacturing, such as CNC machining, and are often associated today with 3D printing or additive manufacturing.
With CNC machining, device manufacturers may use a slightly modified program to customize implants on a per-patient basis. Siemens provides automation that templates the manufacturing process and the CNC tool paths.
“When you update the underlying patient geometry, that causes an update in the template, and those changes automatically progress downstream to the programs that are updated on the CNC machines,” Thompson says.
Within Technologies provides software that creates micro lattice structures for 3D printed orthopaedic devices. “We’ve exploited the benefits of 3D printing and designed software that aligns itself with certain 3D printers to create a complex lattice structure that integrates with a solid substrate,” says Shane Fox, Business Development Specialist, Within Technologies. “We were able to design trabecular lattice structures that mimic organic bone growth, and promote osteointegration.”
After the component is designed digitally, it is exported to be manufactured.
Utilizing additive manufacturing to create custom implants has several benefits for manufacturers.
“Big companies find that the primary benefit is, it can reduce the costs and waste of materials,” Fox says. “By light-weighting or optimizing a component, you’re saving on materials. At times you can save 20 to 40 percent on material waste. We’ve been able to prove that certain orthopaedic designs are already able to produce parts cheaper through additive manufacturing than traditional.”