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.

Bridging the gap between education and medical practice, centralized hospital-based 3D printing, or what is termed point-of-care (POC) manufacturing, has been rapidly growing in the United States as well as internationally. This article provides insights into the considerations and the current workflow of creating 3D-printed anatomical models at the POC. Case studies are introduced to show the complex range of anatomical models that can be produced while also exploring how patient care benefits. It describes the advanced form of communication in medicine. The advantages as well as pitfalls of using the patient-specific 3D-printed models at the POC are addressed, demonstrating the fundamental knowledge needed to create 3D-printed anatomical models through POC manufacturing.

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.

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.

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.

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.

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 the concepts of quality control (QC) and quality assurance (QA), and clarifies the differences and similarities in the roles and responsibilities of QC and QA personnel. It describes the inspection procedures used to verify proper surface preparation and installation of the protective coating/lining system. Prior to beginning surface-preparation operations, many specifications will require a presurface-preparation inspection to verify the correction of fabrication defects and removal of surface contamination such as grease, oil, cutting compounds, lubricants, and chemical contaminants. When inspecting concrete prior to coating installation, three areas of concern exist: surface roughness, moisture content in concrete, and acidity/alkalinity of the surface. The article provides information on the industry standards for assessing surface cleanliness. It details postcoating application quality requirements, including measuring of dry-film thickness, assessing intercoat cleanliness, verifying minimum and maximum recoat intervals, performing holiday/pinhole detection, conducting cure/hardness testing, and assessing adhesion of the applied coating system.

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 describes the eight chemical cleaning methods, namely, circulation, fill and soak, cascade, foam, vapor-phase organic, steam-injected, on-line chemical, and mechanical cleaning. It presents information on deposit types, solvents used to remove them, and construction material incompatibilities in a table. The article summarizes the uses of chemical cleaning solutions, including hydrochloric acid, phosphoric acid, and sulfamic acid, as well as the additives used to neutralize their impact on corrosion. It discusses the chemical cleaning procedures, including selection of cleaning method and solvent, documentation of cleaning, and corrosion monitoring in chemical cleaning.

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.

This article discusses pressure vessels, piping, and associated pressure-boundary items of the types used in nuclear and conventional power plants, refineries, and chemical-processing plants. It begins by explaining the necessity of conducting a failure analysis, followed by the objectives of a failure analysis. Then, the article discusses the processes involved in failure analysis, including codes and standards. Next, fabrication flaws that can develop into failures of in-service pressure vessels and piping are covered. This is followed by sections discussing in-service mechanical and metallurgical failures, environment-assisted cracking failures, and other damage mechanisms that induce cracking failures. Finally, the article provides information on inspection practices.