Additive manufacturing, or three-dimensional printing technologies, for biomedical applications is rather different from other engineering components, particularly for biomedical implants that are intended to be used within the human body. This article contains two sections: "Design and Manufacturing Considerations of 3D-Printed, Commercially Pure Titanium and Titanium Alloy-Based Orthopedic Implants" and "Device Testing Considerations Following FDA Guidance" for additive-manufactured medical devices. These are further subdivided into five major focus areas: materials; design, printing, printing characteristics and parameters as well as postprinting validation; removal of the many manufacturing material residues and sterilization; physical, chemical, and mechanical assessments of the final devices; and biological considerations of all the final devices including biocompatibility.

This article commences with a description of the prosthetic devices and implants used for internal fixation. It describes the complications related to implants and provides a list of major standards for orthopedic implant materials. The article illustrates the body environment and its interactions with implants. The considerations for designing internal fixation devices are also described. The article analyzes failed internal fixation devices by explaining the failures of implants and prosthetic devices due to implant deficiencies, mechanical or biomechanical conditions, and degradation. Finally, the article discusses the fatigue properties of implant materials and the fractures of total hip joint prostheses.

Implant debris is known to cause local inflammation, local osteolysis, and, in some cases, local and systemic hypersensitivity. The debris can be stainless steel, cobalt alloy, and titanium alloy, and soluble debris obtained due to wear from all orthopedic implants. This article addresses the biologic aspects of implant debris, both locally and systemically. It describes debris-induced local effects, particle-induced proinflammatory responses, and debris-induced systemic effects. The article concludes with a discussion on the four systemic effects of implant debris, namely, neuropathic effects, hypersensitivity effects, carcinogenicity, and general toxicity.

This article focuses on the analysis of materials and mechanical- (or biomechanical-) based medical device failures. It reviews the failure analysis practices, including evidence receipt, cleaning, nondestructive examination, destructive examination, exemplars analysis, and device redesign. The article examines the common failure modes, such as overload, fatigue, corrosion, hydrogen embrittlement, and fretting, of medical devices. The failure analysis of orthopedic implants, such as permanent prostheses and internal fixation devices, is described. The article reviews the failure mechanisms in some of the more common medical device materials, namely, stainless steels, titanium alloys, cobalt-base alloys, and nitinol. It presents case histories with examples for failure analysis.

This article is an atlas of fractographs that helps in understanding the causes and mechanisms of fracture of austenitic stainless steels and in identifying and interpreting the morphology of fracture surfaces. The fractographs illustrate the following: fatigue-crack fracture, rock candy fracture, cleavage fracture, brittle fracture, high-cycle fatigue fracture, fatigue striations, hydrogen-embrittlement failure, creep crack propagation, fatigue crack nucleation, intergranular creep fracture, torsional overload fracture, stress-corrosion cracking, and grain-boundary damage of these steels. The austenitic stainless steel components include spring wires, preheater-reactor slurry transfer lines and gas lines of coal-liquefaction pilot plants, oil feed tubes and suction couch rolls of paper machines, cortical screws and compression hip screws of orthopedic implants, and Jewett nails.

Bearing in mind the three-legged stool approach of device design/manufacturing, patient factors, and surgical technique, this article aims to inform the failure analyst of the metallurgical and materials engineering aspects of a medical device failure investigation. It focuses on the device "failures" that include fracture, wear, and corrosion. The article first discusses failure modes of long-term orthopedic and cardiovascular implants. The article then focuses on short-term implants, typically bone screws and plates. Lastly, failure modes of surgical tools are discussed. The conclusion of this article presents several case studies illustrating the various failure modes discussed throughout.

This article is an atlas of fractographs that helps in understanding the causes and mechanisms of fracture of cobalt alloys (cast Vitallium and cast ASTM F75 alloys) and in identifying and interpreting the morphology of fracture surfaces. The fractographs illustrate the fatigue fracture, microcrack, and stair-step fracture surface of these alloys.

Metallography plays a significant role in the quality control of metals and alloys used in the manufacture of implantable surgical devices. This article provides information and data on metallographic techniques along with images showing the microstructure of biomedical orthopedic alloys, including stainless steels, cobalt-base alloys, titanium and titanium alloys, porous coatings, and emerging materials.

Powder-bed fusion (PBF) is a group of additive manufacturing (AM) processes that includes selective laser sintering, selective laser melting, and electron beam melting. This article explains the processes and parameters of PBF systems that are used for biomedical applications. It also presents the desirable properties of biomedical devices and the advantages of using PBF systems for biomedical applications.

Biomaterials are the man-made metallic, ceramic, and polymeric materials used for intracorporeal applications in the human body. This article primarily focuses on metallic materials. It provides information on basic metallurgy, biocompatibility, chemistry, and the orthopedic and dental applications of metallic biomaterials. A table compares the mechanical properties of some common implant materials with those of bone. The article also provides information on coatings, ceramics, polymers, composites, cements, and adhesives, especially where they interact with metallic materials.

This article outlines the selection criteria for choosing an implant material for biomedical devices in orthopedic, dental, soft-tissue, and cardiovascular applications. It details the development of various implants, such as metallic, ceramic, and polymeric implants. The article discusses specific problems associated with implant manufacturing processes and the consequent compromises in the properties of functionally graded implants. It describes the manufacturing of the functionally-graded hip implant by using the LENS process. The article reviews four different types of tissue responses to the biomaterial. It discusses the testing methods of implant failure, such as in vitro and in vivo assessment of tissue compatibility.

This article discusses the physical metallurgy of cast cobalt alloys with an emphasis on the crystallography, compositions, phases and microstructure, and properties. Cobalt alloys are cast by several different foundry methods. The article describes the argon-oxygen decarburization and continuous casting process. It provides information on castability and quality of the casted alloys. The article details the postcasting treatment, including heat treatment, hot isostatic pressing, and coatings. It summarizes the applications of cast cobalt alloys.

This article reviews the understanding of corrosion interactions between alloys in complex geometries and in applications where there are significant cyclic stresses and potential for wear and fretting motion. These alloys include iron-base, titanium-base, and cobalt-base alloys. The article discusses the surface characteristics and electrochemical behavior of metallic biomaterials. It summaries the clinical context for mechanically assisted corrosion and describes mechanically assisted crevice corrosion. There have been several tests developed to investigate aspects of mechanically assisted corrosion. The article also explains the scratch test and the in vitro fretting corrosion test.

Of the seven additive manufacturing (AM) processes, this article focuses on the vat photopolymerization, or simply vat polymerization, process, while briefly discussing the other six AM processes. Vat polymerization and its characteristics, AM applications in medical fields, and the regulatory challenges of vat polymerization-based bioprinting are presented.

The biocompatibility of a material relates to its immunological response, toxicity profile, and ability to integrate with surrounding tissue without undesirable local or systemic effects on a patient. This article underscores the transformation of the medical device design ecosystem engaged as an integral part of the device ecosystem. It discusses the applications of biomaterials, including orthopedic, cardiovascular, ophthalmic, and dental applications. The article describes four major categories of biomaterials such as metals, polymers, glass and ceramics, and composites. A discussion on natural materials, nanomaterials, and stem cells is also provided. The article concludes with examples of biomaterials applications, such as endovascular devices, knee implants, and neurostimulation.