Biomedical Devices : Design, Prototyping, and Manufacturing.

Cover -- Title Page -- Copyright -- Contents -- Contributors -- Foreword -- Chapter 1 Overview -- 1.1 Introduction -- 1.2 Need for Medical Devices -- 1.3 Technology Contribution to Medical Devices -- 1.3.1 Subtractive Technologies -- 1.3.2 Net-Shape Technologies -- 1.3.3 Additive Technologies -- 1.4 Challenges in the Medical Device Industry -- References -- Chapter 2 Design Issues in Medical Devices -- 2.1 Medical Device Development (MDD) -- 2.1.1 Biomedical Product Life Cycle -- 2.1.2 Medical Device Development Process -- 2.1.3 Medical Devices' Design Process -- 2.2 Case Study -- 2.2.1 Scapholunate Interosseous Ligament -- 2.2.2 Conceptual Design -- 2.2.3 Embodiment Design -- 2.2.4 Detailed Design -- 2.2.5 Manufacturing a Prototype -- 2.2.6 Tracheal Stent -- 2.2.7 Conceptual Design -- 2.2.8 Embodiment Design and Detail Design -- 2.2.9 Manufacturing a Prototype -- 2.3 Conclusions -- References -- Chapter 3 Forming Applications -- 3.1 Forming -- 3.2 Typical Process Parameters -- 3.2.1 Temperature -- 3.2.2 Flow Stress -- 3.2.3 Strain -- 3.2.4 Strain Rate -- 3.2.5 Tribology and Micro-Tribology -- 3.3 Manufacturing Process Chain -- 3.3.1 Manufacture of Alloys and Raw Materials -- 3.3.2 Forming -- 3.3.3 Machining and Finishing -- 3.3.4 Coating -- 3.3.5 Packaging and Sterilization -- 3.4 Implantable Devices -- 3.5 Bone Implants -- 3.5.1 External Fracture Fixation -- 3.5.2 Artificial Joint Replacement -- 3.5.3 Spinal Implants -- 3.5.4 Craniomandibular Implants -- 3.5.5 Dental Implants -- 3.6 Other Biomedical Applications -- References -- Chapter 4 Laser Processing Applications -- 4.1 Introduction -- 4.2 Microscale Medical Device Applications -- 4.3 Processing Methods for Medical Device Fabrication -- 4.4 Biomaterials Used in Medical Devices -- 4.5 Microjoining of Similar and Dissimilar Materials -- 4.6 Laser Micromachining for Microfluidics.

4.7 Laser Micromachining for Metallic Coronary Stents -- References -- Chapter 5 Machining Applications -- 5.1 Introduction -- 5.2 Machinability of Biocompatible Metal Alloys -- 5.3 Surfaces Engineering of Metal Implants -- 5.4 Wear and Failure of Metal Implants -- 5.5 Micromilling-Based Fabrication of Metallic Microchannels for Medical Devices -- 5.6 Machining-Based Fabrication of Polymeric Microneedle Devices -- 5.7 A Case Study: Milling-Based Fabrication of Spinal Spacer Cage -- 5.7.1 Degenerative Disc Disease -- 5.7.2 Intervertebral Spinal Spacers -- 5.7.3 Prototype Fabrication Using Milling Process -- References -- Chapter 6 Inkjet- and Extrusion-Based Technologies -- 6.1 Introduction -- 6.2 Inkjet Technology -- 6.2.1 Inkjet 3D Printing Technology -- 6.2.2 Materials in Inkjet-Based Technologies -- 6.2.3 Inkjet Printing Methods -- 6.2.4 Inkjet Printing Systems: Processes and Machines -- 6.2.5 Medical Applications of Inkjet Technology -- 6.3 Material Extrusion Technology -- 6.3.1 Material Extrusion-General Principles -- 6.3.2 Extrusion-Based Technologies -- 6.3.3 Medical Applications of Extrusion-Based Systems -- References -- Chapter 7 Certification for Medical Devices -- 7.1 Introduction -- 7.2 The Medical Devices Approval, Registration, or Certification -- 7.3 The Premarket Key Activity: The Demonstration of the Conformity to the Safety and Performance Requirements -- 7.4 The Postmarket Key Activity: The Surveillance -- 7.5 The Role of the Quality Management Systems -- 7.6 The Verification and the Auditing -- 7.7 The Role of the Standards -- 7.8 Examples of Approbation/Certification Roads in Some World Areas -- 7.8.1 European Union -- 7.8.2 United States of America -- 7.8.3 Japan -- 7.8.4 Australia -- 7.8.5 Brazil -- 7.8.6 Canada -- 7.9 In-Depth Studies -- 7.9.1 Essentials of Safety and Performance Principles.

7.9.2 Essentials of the Risk Management -- 7.9.3 Essentials of the Nonclinical Evaluation -- 7.9.4 Essentials of the Clinical Evaluation -- References -- Index -- Supplemental Images -- EULA.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.