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.

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.

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.

Additive manufacturing (AM), or three-dimensional printing, has ushered in an era of mass customization in the many different industries in which it is used. The use of the personalized surgical instrument (PSI) is no exception. Initially, PSIs were not a result of the use of AM; rather, what occurred is an improvement in their methods of manufacturing. This article discusses the fundamentals, benefits, manufacturing, and other application examples beyond orthopedics of PSIs. In addition, an outlook of AM in biomedical applications is also covered.

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.

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.

Ceramics are used widely in a number of different clinical applications in the human body. This article provides a brief history of the bioceramics field and discusses the classification of bioceramics. These include bioinert ceramics, bioactive ceramics, and bioresorbable ceramics. The article describes third-generation bioceramics, classified by Hench and Polak, such as silicate-substituted hydroxyapatite and bone morphogenic protein-carrying calcium phosphate coatings. It reviews several examination methods used to test the biocompatibility of ceramics, namely, biosafety testing, biofunctionality testing, bioactivity testing, and bioresorbability testing.

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.

This article describes mechanical/electrochemical phenomena related to in vivo degradation of metals used for biomedical applications. It discusses the properties and failure of these materials as they relate to stress-corrosion cracking (SCC) and corrosion fatigue (CF). The article presents the factors related to the use of surgical implants and their deterioration in the body environment, including biomedical aspects, chemical environment, and electrochemical fundamentals needed for characterizing CF and SCC. It provides a discussion on the use of metallic biomaterials in surgical implant applications, such as orthopedic, cardiovascular surgery, and dentistry. It addresses key issues related to the simulation of an in vivo environment, service conditions, and data interpretation. These include the frequency of dynamic loading, electrolyte chemistry, applicable loading modes, cracking mode superposition, and surface area effects. The article explains the fundamentals of CF and SCC, and presents the test findings from laboratory, in vivo, and retrieval studies.

Superalloys are nickel, iron-nickel, and cobalt-base alloys generally used for high-temperature applications. Superalloys are used in aircraft, industrial, marine gas turbines, nuclear reactors, spacecraft structures, petrochemical production, orthopedic and dental prostheses, and environmental protection applications. This article discusses the material characteristics, phases, structures, and systems of superalloys. It describes the processing of superalloys, including primary and secondary melting, deformation processing (conversion), powder processing, investment casting, and joining methods. The article also describes the properties, microstructure, and thermal exposure of superalloys. It further discusses the effects of environmental factors on superalloys, including oxidation and hot corrosion. Protective coatings are also discussed. The article provides information on the mechanical properties and chemical composition of nickel, iron, and cobalt-base superalloys in both the cast and wrought forms.

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.

Additive manufacturing (AM), or three-dimensional (3D) printing, is a class of manufacturing processes that create the desired geometries of an object, or an assembly of objects, layer by layer or volumetrically. AM has been used extensively for manufacturing medical devices, due to its versatility to satisfy the specific needs of an intended medical field for the product/device. This article provides a comprehensive review of AM in medical devices by the medical specialty panels of the Food and Drug Administration (FDA) Code of Federal Regulations, Parts 862 to 892, including anesthesiology, ear and nose, general hospital, ophthalmic, plastic surgery, radiology, cardiovascular, orthopedic, dental, neurology, gynecology, obstetrics, physical medicine, urology, toxicology, and pathology. It is classified under these panels, and critical reviews and future outlooks are provided. The application of AM to fabricate medical devices in each panel is reviewed; lastly, a comparison is provided to reveal relevant gaps in each medical field.

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.

Due to its layer-by-layer process, 3D printing enables the formation of complex geometries using multiple materials. Three-dimensional printing for bone tissue engineering is called bioprinting and refers to the use of material-transfer processes for patterning and assembling biologically relevant materials, molecules, cells, tissues, and biodegradable biomaterials with a prescribed organization to accomplish one or more biological functions. Currently, 3D bioprinting constructs can be classified into two categories: acellular and cellular. This article introduces and discusses these two approaches based on the suitable materials for these constructs and the fabrication processes used to manufacture them. The materials are grouped into polymers, metals, and hydrogels. The article also summarizes the commonly used 3D printing techniques for these materials, as well as cell types used for various applications. Lastly, current challenges in tissue engineering are discussed.

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.

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.

Physical vapor deposition (PVD) coatings are harder than any metal and are used in applications that cannot tolerate even microscopic wear losses. This article describes the three most common PVD processes: thermal evaporation, sputtering, and ion plating. It also discusses ion implantation in the context of research and development applications.

This article discusses some of the additive manufacturing (AM) based fabrication of alloys and their respective mechanical, electrochemical, and in vivo performance. Firstly, it briefly discusses the three AM techniques that are most commonly used in the fabrication of metallic biomedical-based devices: binder jetting, powder-bed fusion, and directed-energy deposition. The article then characterizes the electrochemical properties of additive-manufactured/processed cobalt-chromium alloys. This is followed by sections providing an evaluation of the biological response to CoCr alloys in terms of the material and 3D printing fabrication. Discussion on the biological response as a function of direct cellular activity on the surface of CoCr alloys in static conditions (in vitro), in dynamic physiological conditions (in vivo), and in computer-simulated conditions (in silico) are further discussed in detail. Finally, the article provides information on the qualification and certification of AM-processed medical devices.

Metal injection molding (MIM) is a metalworking technology that has its origins as a commercial technology only dating back to the early 1970s. This article explores why the MIM is the preferred solution for many fabricated components. It illustrates the MIM components required for different end-use markets such as electronics and telecommunications, medical, automotive, power hand tools, industries, and firearms.

This article provides an overview of how thermal spray technology has adapted to meet the needs of the orthopaedic industry. It includes the challenges facing the development of artificial joints, substrate material selection criteria, thermal spray solutions, and clinical outcomes of thermal spray coatings. The article focuses on plasma thermal spray, which is the technique most often used to make porous titanium and hydroxyapatite (HA) coatings, such as thermal spray titanium, thermal spray HA, solution-precipitated HA, thermal spray chromium oxide, and thermal spray chromium carbide cermet coatings.