ABSTRACT
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-specic 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 eld 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
CONTENTS
13.1 Introduction .................................................................................................................... 352 13.2 Path to Clinical Use ........................................................................................................353 13.3 Software for Templates: Implant Sizing ......................................................................354 13.4 Dental Industry: Example of Mass Manufactured Personal Products ..................354 13.5 Additive Manufactured Patient-Matched Surgical Guides and Bone Models ...... 355 13.6 Additive Manufactured Generic Product ................................................................... 357 13.7 Additive Manufactured Patient-Matched Implants .................................................. 358 13.8 Hard Tissue Replacement for Cranial Reconstruction ............................................. 359 13.9 Manufacturing Cost: Is Additive Manufacturing a Viable Technology?............... 359 13.10 Role of Imaging Human Anatomy .............................................................................. 361 13.11 Most Common Modalities ............................................................................................ 362
13.11.1 Computed Tomography ................................................................................ 362 13.11.2 Magnetic Resonance Imaging ...................................................................... 362 13.11.3 Ultrasound ...................................................................................................... 362 13.11.4 X-Ray ................................................................................................................ 362
13.12 Segmentation ..................................................................................................................363 13.12.1 Manual .............................................................................................................363 13.12.2 Semi-Automated .............................................................................................363 13.12.3 Automated .......................................................................................................363 13.12.4 Segmentation Accuracy .................................................................................363
