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.

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 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.

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 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.

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.

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.

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.

Bioprinting has been advancing in the field of tissue engineering as the process for fabricating scaffolds, making use of additive manufacturing technologies. In situ bioprinting (also termed intraoperative bioprinting) is a promising solution to address the limitations of conventional bioprinting approaches. This article discusses the main approaches and technologies for in situ bioprinting. It provides a brief overview of the bioprinting pipeline, highlighting possible solutions to improve currently used approaches. Additionally, case studies of in situ bioprinting are provided and in situ bioprinting future perspectives are discussed.

Titanium has been recognized as an element with good mechanical and physical properties, alloying characteristics, and corrosion resistance. Providing an outline of general characteristics and types of titanium alloys, this article discusses the contemporary technology of titanium along with its market developments. It also discusses the application of titanium and titanium alloys in corrosive environments and in aerospace and automotive industries. The article describes the developments in titanium processing and materials technologies, which include the development of sponge production and melting processes, oxide dispersion-strengthened alloys by powder metallurgy techniques, titanium-base intermetallic compounds, and titanium-matrix composites.

This article provides information on personal protective equipment (PPE), consistent with the Occupational Safety and Health Administration's Personal Protective Equipment Standard (29 CFR 1910.132-138). This standard is intended to protect individuals from the risk of injury by creating a barrier against workplace hazards. This article provides guidelines for establishing PPE programs with an overview of the responsibilities for employers, supervisors, and employees, assessing hazards associated with thermal spray operations, and training workers about PPE, as well as guidelines for selecting, using, and maintaining PPE. It presents an overview of eye, face, head, hand, foot, hearing, fall, and respiratory protection. Respiratory and hearing protection should be used in conjunction with industrial hygiene monitoring.

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 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.

Ion implantation involves the bombardment of a solid material with medium-to-high-energy ionized atoms and offers the ability to alloy virtually any elemental species into the near-surface region of any substrate. This article describes the fundamentals of the ion implantation process and discusses the advantages, limitations, and applications of ion implantation. It also reviews a typical medium current semiconductor implanter adapted for implantation of metals with the aid of illustrations.

Titanium and its alloys have been used extensively in a wide variety of implant applications, such as artificial heart pumps, pacemaker cases, heart valve parts, and load-bearing bone or hip joint replacements or bone splints. This article discusses the properties of titanium and its alloys and presents a list of titanium-base biomaterials. Titanium components are produced in wrought, cast, and powder metallurgy (PM) form. The article describes forging, casting, and heat treating of titanium alloys for producing titanium components. Typical mechanical properties of titanium biomedical implant alloys are listed in a tabular form. The article presents an overview of the surface-modification methods for titanium and its alloys implants. It concludes with a section on biocompatibility and in vivo corrosion of titanium alloys.

This article is a pictorial guide to forms of corrosion that draws attention to common pitfalls or situations that have caused premature corrosion, sometimes with expensive consequences. The examples used are not exhaustive; they highlight the necessity to fully examine materials, conditions, and specific circumstances that together can reduce the anticipated service life of a component or plant. The color images in this article are categorized according to the type of corrosion following the general order that is adopted in Volume 13A of ASM Handbook. The first table of the article provides a categorization of the forms of corrosion. It also provides a reference to articles or sections of articles in Volume 13A that detail the particular corrosion form or mechanism. The second table is a guide listing the figures in this article by material and by the corrosion form or mechanism illustrated.

This article describes the numerous techniques used to measure friction. It provides a brief description of the historical development of friction testing. The article discusses the tests and equipment available for friction testing. It explains the procedural considerations that should be addressed to ensure that valid data are derived from a friction test. The article presents definitions of terms commonly used in tribology such as static friction, kinetic coefficient of friction, stick-slip behavior, and lubricated friction. It provides information on the precautions that must be taken to ensure valid test results. The article also describes how to report data and how to analyze these data.