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 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.

Three-dimensional plotting of biomaterials (also known as bioprinting) has been a major milestone for scientists and engineers working in nanobiotechnology, nanoscience, and nanomedicine. It is typically classified into two major categories, depending on the plotting principle, as contact and noncontact techniques. This article focuses on the working principles of contact and noncontact printing methods along with their advantages, disadvantages, applications, and challenges. Contact printing methods include micro-plotter, pen printing, screen printing, nanoimprint printing, flexography printing, and gravure printing. Noncontact printing methods include extrusion printing, droplet printing, laser-based polymerization, and laser-based cell transfer. The wide variety of printable biomaterials, such as DNA, peptides, proteins, lipids, and cells, also are discussed.

Additive manufacturing (AM) technologies print three-dimensional (3D) parts through layer-by-layer deposition based on the digital input provided by a computer-aided design file. This article focuses on the binder jet printing process, common biomaterials used in this AM technique, and the clinical applications relevant to these systems. It reviews the challenges and future directions of binder-jetting-based 3D printing.

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.

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.

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.

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.

Microvalve jetting, with its advantages of low cost, ease of operation, high printing speed, and ability to process living cells with high viability, has been primarily used for fabricating high-throughput drug-screening models, in vitro cellular structures for fundamental cell biology research, and cell-laden structures for regenerating tissues or organs in the human body after disease or trauma. This article provides an overview of microvalve jetting of biomaterials, including operational parameters. The jetting technologies covered are inkjet printing, microvalve jetting, and laser-assisted jetting. The parameters covered include nozzle size (nozzle inner diameter), pneumatic pressure, valve-opening time, and printing speed of microvalve jetting. Subsequently, the article discusses biomaterials for microvalve jetting in terms of biomaterial definition, required properties for a suitable biomaterial, currently used biomaterials, and cells and cellular structures. Additionally, applications of microvalve jetting in biomedical engineering are presented, which include cellular and RNA analysis, high-throughput drug screening, and tissue engineering.

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.

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 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.

This article discusses alginate/gelatin-based bioinks in 3D bioprinting applications, providing a summary of the most relevant previous work in the field. It presents advanced compositions to enhance functionality and/or optimize hydrogels for 3D bioprinting. The article discusses advanced printing techniques for alginate/gelatin-based bioinks.

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 discusses electrospinning as a method for obtaining nanofibers, some of the challenges and limitations of the technique, advancements in the field, and how it may be used in key functional applications. The key drawbacks of traditional electrospinning processes include relatively slow speed of nanofiber production, low product yield, and relatively high cost. The article also addresses novel high-throughput techniques and methods designed for the scalable synthesis of nanofibers and nanofibrous mats that are of reasonable cost.

The application of three-dimensional printers can be revolutionary as a tool for the customization and personalization of pharmaceutical dosage forms. The areas of 3D printing applicable to pharmaceutical manufacturing can be segregated into three categories: extrusion technologies, powder-bed fusion, and stereolithography. Common extrusion-based technologies are fused deposition modeling and pressure-assisted microsyringe; powder-bed fusion is separated by binder jet and selective laser sintering. The synergies between pharmaceutical, or active pharmaceutical ingredient (API), and polymer printing are discussed in this article, with particular attention to how the incorporation of small-molecule APIs changes the material selection, design considerations, processing parameters, and challenges associated with each technology.

Porous coatings are used in the field of joint replacement, particularly in cementless total hip/knee arthroplasty. This article reviews the offerings and biomaterial properties in orthopedic surgery for the contemporary class of highly porous metals. It describes the traditional porous metals/coatings having an open-cell structure, high porosity, and a microstructure resembling that of the cancellous bone. The traditional porous metal/coating includes fiber-metal mesh, cobalt-chromium (CoCr) beads, cancellous-structured titanium, and plasma spray. The article discusses other porous metals/coatings that have been developed due to the limitations of traditional porous metals for numerous open-cell-structured metals, such as titanium-base foams and trabecular metals.

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.

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.