Stainless steels are used for medical implants and surgical tools due to the excellent combination of properties, such as cost, strength, corrosion resistance, and ease of cleaning. This article describes the classifications of stainless steels, such as austenitic stainless steels, martensitic stainless steels, ferritic stainless steels, precipitation-hardening stainless steels, and duplex stainless steels. It contains a table that lists common medical device applications for stainless steels. The article discusses the physical metallurgy and physical and mechanical properties of stainless steels. Medical device considerations for stainless steels, such as fatigue strength, corrosion resistance, and passivation techniques, are reviewed. The article explains the process features of implant-grade stainless steels, including type 316L, type 316LVM, nitrogen-strengthened, ASTM F1314, ASTM F1586, ASTM F2229, and ASTM F2581 stainless steels.

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.

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.

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 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 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.

Physically, tantalum is a dark, blue-gray, lusterless metal that exists in two crystalline forms: an alpha-phase with a body-centered cubic structure, and a brittle beta-phase with a tetragonal orientation. This article tabulates the physical and material properties of tantalum. It discusses the use of tantalum in medical electronics and the advantage of tantalum over stainless steel. The article describes the manufacturing and medical applications of tantalum foam.

Metal powders are used as fuels in solid propellants, fillers in various materials, such as polymers or other binder systems, and for material substitution. They are also used in food enrichment, environmental remediation market, and magnetic, electrical, and medical application areas. This article reviews some of the diverse and emerging applications of ferrous and nonferrous powders. It also discusses the functions of copier powders and the processes used frequently for copier powder coating.

Ultrasound is an ideal modality for nondestructive evaluation (NDE) because it enables the interior of objects to be assessed without the safety and access issues associated with radiography. This article summarizes the history of array usage in NDE and its relationship to medical applications. It discusses the mathematics behind classical beamforming, full matrix capture, and total focusing methods of imaging. The article shows how ultrasonic array data can be simulated by direct numerical methods (most commonly using finite-element methods), analytical methods, or hybrid methods. It also considers various methods of comparing the performance of arrays and imaging algorithms. The article provides a comparison of various advanced and nonlinear imaging algorithm and looks at some practical industrial applications of arrays. It concludes with some future perspectives for arrays in NDE.

Additive manufacturing (AM) techniques include powder-bed fusion (PBF), directed-energy deposition, binder jetting (BJ), extrusion-based desktop, vat photopolymerization, material jetting, and sheet lamination. The development of suitable powders for AM is a challenging task because of critical design parameters including chemical composition, flowability of powders, and melt surface tension. This article explains the fabrication methods of metal and novel alloy powders for medical applications. The development of zirconium alloy powder for laser-PBF is introduced as a case study.

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.

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.

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.

Microjoining methods are commonly used to fabricate medical components and devices. This article describes key challenges involved during microjoining of medical device components. The primary mechanisms used in microjoining for medical device applications include microresistance spot welding (MRSW) and laser welding. The article illustrates the fundamental principles involved in MRSW and laser welding. The article presents examples of various microjoining methods used in medical device applications, including pacemaker and nitinol microscopic forceps.

This article presents the history of standardization in additive manufacturing (AM). It explains the need and structure for standardization in AM, including the application of AM standards by the industry sector. It also presents the primary purposes of these standards to create AM qualification and certification frameworks.

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.