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.

Polymers offer a wide range of choices for medical applications because of their versatility in properties and processing. This article provides an overview of polymeric materials and the characteristics that make them a unique class of materials. It describes the ways to classify polymers, including the polymerization method, how the material deforms, or molecular origin or stability. The article contains tables that list common medical polymers used in medical devices. It explains the medical polymer selection criteria and regulatory aspects of materials selection failure analysis and prevention. Failure analysis and prevention processes to determine the root cause of failures that arise at different stages of the product life cycle are reviewed. The article describes the mechanisms of plastic product failure analysis. It discusses the trends in the use of medical polymers, such as high-performance polymers for implants, tissue engineering, and bioresorbable polymers.

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.

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.

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.

Vat polymerization is a form of three-dimensional (3D) printing. Historically, it is the oldest additive manufacturing technique, with the development of stereolithography apparatus (SLA) by Charles Hull in 1986. This article outlines the various forms of vat polymerization techniques used for biomedical applications. Due to the complex nature of this printing process, many key print parameters and material properties need to be considered to ensure a successful print. These influential parameters are addressed throughout the article to inform the reader of the considerations that should be taken when using the vat polymerization technique. The article provides information on vat polymerization printer setup, the photo-cross-linking mechanism, and considerations using vat polymerization. In addition, it outlines and discusses the advancements of vat polymerization in the biomedical industry.

This article discusses several aspects of biocompatibility of polymers, including the selection of a suitable polymer, specific use of a material, contact of polymer on body site, and duration of the contact. It describes the factors influencing the biological response of the polymer from a biocompatibility perspective. These include raw materials, the manufacturing process, cleaning and sterilization processes, and biodegradation and biostability. The article reviews the general testing methods of polymers, such as chemical, mechanical and thermal. It concludes with a section on the guidance, provided by the regulatory authorities, on the biocompatibility testing of polymers and polymer-containing devices that can aid in selecting the right analysis.

Total joint replacement in orthopedic surgery can be achieved by excision, interposition, and replacement arthroplasty. This article details the most common materials used in total replacement synovial joints: metals, ceramics, and ultrahigh molecular weight polyethylene (UHMWPE). The principal physical properties and tribological characteristics of these materials are summarized. The article discusses pin-on-disk experiments and pin-on-plate experiments for determining friction and wear characteristics. It explains the use of various types of joint simulators, such as hip joint simulators and knee joint simulators, to evaluate the performance of engineering tribological components in machine simulators. The article concludes with a section on the in vivo assessment of total joint replacement performance.

This article provides an overview of the adoption of additively manufactured materials in dentistry. It discusses the practical workflows of a three-dimensional printing technology, vat photopolymerization. Three subgroups of the vat photopolymerization process are laser beam or classic stereolithography apparatus (SLA), direct light processing, and liquid-crystal-display-masked SLA. The article covers two subgroups of 3D printing resins-based appliances, namely intraoral and extraoral appliances. Information on various types of dental appliances and the fabrication of in-office appliances is provided. The article also reviews fourth-dimension printing and discusses the applications of the personalized care model in medicine and dentistry.

The article presents an in-depth discussion on the various additive manufacturing techniques such as binder jetting, directed-energy deposition, material extrusion, material jetting, powder-bed fusion, sheet lamination, and vat polymerization processes. This article then discusses the different critical material aspects of additively manufactured medical devices, beginning with the preprinting phase (material consistency and recycling), the printing phase (build orientation), and the postprinting phase (part evaluation, biocompatibility, and sterilization) with supporting materials.

Inkjet printing is extremely precise in terms of the ejected microdroplets (picoliter volume), contributing an unparalleled lateral resolution. Additionally, the benefits of high-speed deposition, contactless ink delivery, and the use of a range of ink materials endorse this technique as suitable for high-throughput 3D manufacturing. This article provides an overview of inkjet 3D printing (also referred to as 3D inkjetting). It then highlights the major components and accessories used in commercial and laboratory-based 3D inkjet printers. Next, the article describes the process physics of the transient phenomena involved in both binder-jetting- and direct-inkjetting-based 3D printing. It then discusses the scope and advantages of 3D inkjetting in the manufacturing of metallic, ceramic, and polymer-based biomaterials. The article also discusses several approaches and methodologies to examine the in vitro cytocompatibility and in vivo biocompatibility of both binder-jetted and direct-inkjetted scaffolds for biomedical applications. Finally, it discusses the challenges and troubleshooting methodologies in 3D inkjetting of biomaterials.

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.

The human internal environment plays a vital role in the friction and wear of implants and prosthetic devices. This article describes the tribological/wear behavior of implants. It discusses the classification of active tribological pairs, namely, amphiarthosis joints and diarthosis joints. The article details the classification of total knee replacement, depending on the type of mechanical stability, including nonconstrained knee replacement, semiconstrained knee replacement, and constrained knee replacement. It also discusses the classifications of passive tribological pairs, namely, total disc replacement in the spine, dental implants, and temporomandibular joint. It describes the various testing methods for characterizing the implant materials used in hip, knee, spine, and dental applications. The article also describes the typical standards used for testing wear behavior of tribological pairs, namely, hip-wear simulation standards, knee-wear simulation standards, and spinal disc-wear simulation standards.

This article provides a summary of the biocompatibility or biological response of metals, ceramics, and polymers used in medical implants, along with their clinical issues. The polymers include ultrahigh-molecular-weight polyethylene, nonresorbable polymer, and resorbable polymers.

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.

Additive manufacturing (AM), also referred to as three-dimensional printing or rapid prototyping, is a set of technologies that has rapidly evolved and has drawn much research attention in the manufacturing of high value-added products. This article focuses on dentistry, one of the fields in which AM has gained much traction. It discusses the AM processes used to produce dentures, crowns, and bridges. Digitization techniques, which are the first step and provide the CAD model for AM processes, are presented. Scanning technologies that are widely used in dental manufacturing are presented in detail, and the strengths and weaknesses of each process within their applications are discussed. AM processes are discussed in detail, and the materials that are widely used in AM-embedded dental manufacturing are briefly surveyed. The final section concludes with remarks and a preview of future research and practice directions.

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.

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.

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.