ABSTRACT
Additive manufacturing is fast gaining a presence in the manufacturing of personalized medical implants. This chapter discusses the use of additive manufacturing and necessary imaging technology for the generation of custom orthopedic implants with patient-specific designs. The chapter discusses how existing regulations can be adopted to address and mitigate some of the risks associated with medical device manufacturing. However, recognizing that the field of additive manufacturing in orthopedic implant manufacturing is relatively new, the chapter initiates the reader into the realm of medical device regulations. Moreover, the chapter discusses the processing steps necessary in the making of various instruments and implants. Many opponents of the technology raise the issue of cost as a reason not to embrace this technology. This chapter addresses the question of cost by comparing the processing route of an implant via traditional methods to that via the additive manufacturing method. Such comparison gives the true estimate of cost and therefore the real value of additive manufacturing for personalized medicine. Further, the chapter exposes the reader to various modalities and limitations of imaging techniques and their role in generating the necessary patient-specific designs that will become additive manufactured parts. As the field of additive manufacturing is still relatively new, there is the need for supporting quality control technology that must mature to provide the necessary confidence in implant performance for wider acceptance. This chapter calls out such emerging quality control technology and how supporting technology that exists today could be adapted to help alleviate such misgivings. The chapter closes with the authors’ imagination of the future of orthopedics and personalized implants, instruments, and guides.
