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.

This article tabulates materials that are known to have been used in orthopaedic and/or cardiovascular medical devices. The materials are grouped as metals, ceramics and glasses, and synthetic polymers in order. These tables were compiled from the Medical Materials Database which is a product of ASM International and Granta Design available by license online and as an in-house version. The material usage was gleaned from over 24,000 U.S. Food and Drug Administration (USFDA), Center for Devices and Radiological Health, Premarket notifications (510k), and USFDA Premarket Approvals, and other device records that are a part of this database. The database includes other material categories as well. The usage of materials in predicate devices is an efficient tool in the material selection process aiming for regulatory approval.

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.

This article provides an overview of curing techniques, adhesive chemistries, surface preparation, adhesive selection, and medical applications of adhesives. The curing techniques are classified into moisture, irradiation, heat, and anaerobic. The article highlights the common types of curable adhesives used for medical device assemblies, including acrylics, cyanoacrylates, epoxies, urethanes, and silicones. Other forms of adhesives, such as hot melts, bioadhesives, and pressure-sensitive adhesives, are also discussed. The typical characteristics and applications of biocompatible medical device adhesives are listed in a table. The article concludes with a section on the selection of materials for medical adhesives.

This article provides a background to the biological evaluation of medical devices. It discusses what the ISO 10993 standards require for polymeric biomaterials and presents examples of qualitative and quantitative tests that can be used to satisfy these requirements. The article describes infrared (IR) and thermal analyses that are used extensively to fingerprint polymeric materials. It also presents a discussion on the chemical characterization and risk assessment of extracts. Background information on risk assessments of extracts is also included. The four basic steps that are commonly used in the risk assessment process are discussed. These include hazard identification, dose-response assessment, and exposure assessment, and risk characterization.

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.

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.

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.

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.

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 (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 currently available metal AM processes for the medical industry; outlines a step-by-step review of the typical workflow for design, manufacturing, evaluation, and implantation of patient-specific AM devices; and examines the existing research trends in medical applications of AM with specific focus on metallic biomedical implants. Finally, challenges and opportunities for future developments in AM pertaining to the medical field are also explored.

According to International Organization for Standardization (ISO)/ASTM International 52900, additive manufacturing (AM) can be classified into material extrusion, material jetting, vat photo polymerization, binder jetting, sheet lamination, powder-bed fusion (PBF), and directed-energy deposition. This article discusses the processes involved in polymer powder 3D printing using laser fusion/ sintering and fusing agents and energy, as well as the thermally fused PBF. It provides information on polymer powder parameters and modeling, the powder-handling system, powder characterization, the flowability of powder feedstock, and polymer part characteristics. The article describes the types of polymers in PBF, the processes involved in powder recycling, and the prospects of PBF in AM. In addition, the biomedical application of polyether ether ketone (PEEK) is also covered.

This article provides an overview of additive manufacturing (AM) methods, the three-dimensional (3D)-AM-related market, and the medical additive manufactured applications. It focuses on the current scenario and future developments related to metal AM for medical applications. The discussion covers the benefits of using 3D-AM technology in the medical field, provides specific examples of medical devices fabricated by AM, reviews trends in metal implant development using AM, and presents future prospects for the development of novel high-performance medical devices via metal 3D-additive manufacturing.

This article provides highlights of the general process and workflow of creating a 3D-printed model from a medical image and discusses the applications of additively manufactured materials. It provides a brief background on Food and Drug Administration (FDA) classification and regulation of medical devices, with an emphasis on 3D-printed devices. Then, the article discusses two broad applications of 3D printing in craniofacial surgery: surgery and education. Next, it discusses, with respect to surgical applications, preoperative planning, use in the operating room, surgical guides, and implants. The article includes sections on education that focus on the use of 3D-printed surgical simulators and other tools to teach medical students and residents. It briefly touches on the FDA regulations associated with the respective application of 3D printing in medicine. Lastly, the article briefly discusses the state of medical billing and reimbursement for this service.

This article provides a summary of the concepts discussed in the Section “Corrosion in Specific Industries” in the ASM Handbook, Volume 13C:Corrosion: Environments and Industries. This Section applies the fundamental understanding of corrosion and knowledge of materials of construction to practical applications. The industries addressed are nuclear power, fossil and alternative fuel, land transportation, air transportation, microelectronics, chemical processing, pulp and paper, food and beverage, pharmaceutical and medical technology, petroleum and petrochemical, building, and mining and metal processing.

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.

Material jetting (MJ) is a classification of additive manufacturing processes that involves the selective jetting and subsequent solidification of liquid droplets onto a substrate in a layerwise manner. This article focuses solely on MJ of polymers, providing a process overview and describing the functional characteristics that distinguish it from other AM technologies. It provides information on the properties and design considerations of both build and support materials. Process-related effects on final part properties and overall quality, as well as corresponding design considerations are also covered. The article also discusses the applications and future scope of polymer MJ systems.

This article focuses on the modes of operation, physical basis, sample requirements, properties characterized, advantages, and limitations of the characterization methods used to evaluate the physical morphology and chemical properties of component surfaces for medical devices. These methods include light microscopy, scanning electron microscopy, atomic force microscopy, energy-dispersive X-ray spectroscopy, Auger electron spectroscopy, secondary ion mass spectrometry, X-ray photoelectron spectroscopy, Fourier transform infrared spectroscopy, and Raman spectroscopy.