Search Results for medical device design

This article focuses on the specific aspects of nitinol that are of interest to medical device designers. It describes the physical metallurgy, physical properties, and tensile properties of the nitinol. The article discusses the factors influencing superelastic shape memory effects, fatigue, and corrosion in medical device design. It reviews the biocompatibility of nitinol based on corrosion behavior. The article explains the general principles, potential pitfalls, and key properties for manufacturing, heat treatment, and processing of nitinol.

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.

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 contains a table that lists the ISO standards for the biological evaluation of medical devices.

This article focuses on the analysis of materials and mechanical- (or biomechanical-) based medical device failures. It reviews the failure analysis practices, including evidence receipt, cleaning, nondestructive examination, destructive examination, exemplars analysis, and device redesign. The article examines the common failure modes, such as overload, fatigue, corrosion, hydrogen embrittlement, and fretting, of medical devices. The failure analysis of orthopedic implants, such as permanent prostheses and internal fixation devices, is described. The article reviews the failure mechanisms in some of the more common medical device materials, namely, stainless steels, titanium alloys, cobalt-base alloys, and nitinol. It presents case histories with examples for failure analysis.

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 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, or three-dimensional printing technologies, for biomedical applications is rather different from other engineering components, particularly for biomedical implants that are intended to be used within the human body. This article contains two sections: "Design and Manufacturing Considerations of 3D-Printed, Commercially Pure Titanium and Titanium Alloy-Based Orthopedic Implants" and "Device Testing Considerations Following FDA Guidance" for additive-manufactured medical devices. These are further subdivided into five major focus areas: materials; design, printing, printing characteristics and parameters as well as postprinting validation; removal of the many manufacturing material residues and sterilization; physical, chemical, and mechanical assessments of the final devices; and biological considerations of all the final devices including biocompatibility.

Metallic alloys that are typically used for medical purposes include stainless steels, Ti-6Al-4V, and Co-Cr-Mo. This article discusses the relative merits of each of these alloys. The utilization of stainless steels in the biomedical industry, especially in relation to the additive manufacturing (AM) process, is the main focus of this article. The characteristics of various stainless steels are described subsequently, and the categories that are of relevance to the biomedical industry are identified. The types of stainless steels covered are austenitic, ferritic, martensitic, duplex, and precipitation-hardened stainless steels. The article discusses the potential benefits of AM for biomedical devices. It describes the types of AM processes for stainless steels, namely binder jet, directed-energy deposition, and laser powder-bed fusion. The article reviews the AM of austenitic, martensitic, and PH stainless steels for biomedical applications. In addition, the challenges and obstacles to the clinical use of AM parts are covered.

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.

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.

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.

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.

Metallography plays a significant role in the quality control of metals and alloys used in the manufacture of implantable surgical devices. This article provides information and data on metallographic techniques along with images showing the microstructure of biomedical orthopedic alloys, including stainless steels, cobalt-base alloys, titanium and titanium alloys, porous coatings, and emerging materials.

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.

Metal injection molding (MIM) is a metalworking technology that has its origins as a commercial technology only dating back to the early 1970s. This article explores why the MIM is the preferred solution for many fabricated components. It illustrates the MIM components required for different end-use markets such as electronics and telecommunications, medical, automotive, power hand tools, industries, and firearms.