Medical Device & Diagnostic Industry

ing this step only for the end, however, the team saved significant time while still ensuring that the physical creation met the patient’s requirements.

Manufacturing. Once the surgeon authorized the implant design, the contract manufacturer created machine-specific instructions for the EBM manufacturing technique. As mentioned before, short-run or one-off creations of implants are achievable using EBM manufacturing. The EBM process is capable of producing components in commercially pure titanium, titanium alloy, and cobalt chrome alloys. In the process, a high-power electron beam is used to melt successive layers of metal from powdered raw material, thus forming a solid, metallic part in an additive fashion. In addition to supporting extremely complex, organic shapes, EBM is less expensive and faster than forging or machining, both of which are better suited for larger-volume runs.

Finishing, Sterilization, and Final Delivery. The manufacturer delivered the custom implant to the orthope-

dics company, which then machined the outer surface that comes into contact with the surrounding tissues. The undersurface of the implant was left in the rough, as-produced state to allow for tissue integration behind the implant. The final finishing steps of the implant development included threading fixed-angle screw holes to accommodate locking-screw fixation. The device was cleaned, sterilized, and packaged in-house.

The optimal fit of the implant allowed surgeons to complete the surgery in three hours—half the anticipated surgical time. Implant design and production took place in two weeks from CT scan transmission to delivery of the finished implant to the surgeon, which is also about half the time usually required. Total costs for this case were comparable to a traditional off-the-shelf implant.

The Case for Customization

Although patient data on outcomes from custom approaches are new and

still limited, it is logical to assume better patient outcomes with such personalization. Researchers are also studying whether there is increased longevity for personalized implants.

Beyond these assumptions, using external contract manufacturing resources for customized implants makes business sense for ensuring optimal delivery time to the patient, as demonstrated by the example in this article. However, working with a contract manufacturer is not without challenges. Surgery dates are always uncomfortably close, communication between partners can be difficult, and expectations are high. These challenges can be overcome by structuring the relationship to create a partnership in which each company focuses on deploying its unique expertise in service of the surgeon and, most importantly, the patient.

Reference

1. The 2007–2008 Orthopaedic Industry An-

nual Report, Knowledge Enterprises Inc.

(Chagrin Falls, OH), July 2008. ■

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