Biomedical Devices

Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues.* Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume* Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications* Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures* Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

List of ContributorsForewordChapter 1: Introduction1.1 Introduction1.2 Need for Medical Devices1.3 Technology Contribution to Medical Devices1.4 Challenges in Medical Device IndustryChapter 2: Design issues in medical devices2.1 Biomedical product life cycle2.2 Medical device development process2.3 Medical devices design process2.4 Case study2.4.1 Scapholunate interosseous ligament2.4.2 Tracheal stent2.5 ConclusionsReferencesChapter 3: Forming Applications3.1 Typical Process Parameters3.1.1 Temperature3.1.2 Flow stress3.1.3 Strain3.1.4 Strain rate3.1.5 Tribology and micro-tribology3.2 Manufacturing process chain3.2.1 Manufacture of alloys and raw materials3.2.2 Forming3.2.3 Machining and finishing3.2.4 Coating3.2.5 Packaging and sterilization3.3 Implantable devices3.4 Bone implants3.4.1 External fracture fixation3.4.2 Artificial joint replacement3.4.3 Spinal implants3.4.4 Craniomandibular implants3.4.5 Dental implants3.5 Other biomedical applicationsReferencesChapter 4: Laser Processing Applications4.1 Introduction4.2 Micro-scale medical devices applications4.3 Processing methods for medical device fabrication4.4 Biomaterials used in medical devices4.5 Micro-joining of similar and dissimilar materials4.6 Laser micromachining for microfluidics4.7 Laser micromachining for metallic coronary stentsReferencesChapter 5: Machining Applications5.1 Introduction5.2 Machinability of biocompatible metal alloys5.3 Surfaces engineering of metal implants5.4 Wear and failure of metal implants5.5 Micro milling-based fabrication of metallic micro channels for medical devices5.6 Machining-based fabrication of polymeric micro needle devicesReferencesChapter 6: Inkjet and Extrusion Based Technologies6.1 Introduction6.2 Inkjet Technology6.2.1 Inkjet 3D Printing Technology6.2.2 Materials in Inkjet Based Technologies6.2.3 Inkjet Printing Methods6.2.4 Inkjet Printing Systems: Processes and Machines6.2.5 Medical Applications of Inkjet Technology6.3 Material Extrusion Technology6.3.1 Material Extrusion - General Principles6.3.2 Extrusion based Technologies6.3.3 Medical Applications of Extrusion-based systemsReferencesChapter 7: Certification for medical devices7.1 The medical devices approval, registration or certification7.2 The pre-market key activity: the demonstration of the conformity to the safety and performance requirements7.3 The post-market key activity: the surveillance7.4 The role of the quality management systems7.5 The verification and the auditing7.6 The role of the Standards7.7 Examples of approbation/certification roads in some world areas7.7.1 European Union7.7.2 United States of America7.7.3 Japan7.7.4 Australia7.7.5 Brazil7.7.6 Canada7.8 In depth studies7.8.1 Essentials of safety and performance principles (Source: IMDRF document GHTF/SG1/N68:2012)7.8.2 Essentials of the risk management (Source: IMDRF document GHTF/SG3/N15R8)7.8.3 Essentials of the not-clinical evaluation7.8.4 Essentials of the clinical evaluation (Source: IMDRF documents GHTF/SG5/N1R8:2007-N2R28:2007-N3:2010)7.9 References7.10 List of TablesIndex