Biomedical Devices

CONTRIBUTORS ix

FOREWORD xi

1 Overview 1
Joaquim De Ciurana Gay, Tu¢grul -zel, and Lidia Seren³

1.1 Introduction, 1

1.2 Need for Medical Devices, 7

1.3 Technology Contribution to Medical Devices, 12

1.3.1 Subtractive Technologies, 13

1.3.2 Net-Shape Technologies, 13

1.3.3 Additive Technologies, 14

1.4 Challenges in the Medical Device Industry, 16

References, 17

2 Design Issues in Medical Devices 23
In©s Ferrer, Jordi Grabalosa, Alex Elias-Zu±iga, and Ciro Angel Rodriguez

2.1 Medical Device Development (MDD), 23

2.1.1 Biomedical Product Life Cycle, 24

2.1.2 Medical Device Development Process, 27

2.1.3 Medical Devicesâ Design Process, 28

2.2 Case Study, 30

2.2.1 Scapholunate Interosseous Ligament, 30

2.2.2 Conceptual Design, 32

2.2.3 Embodiment Design, 35

2.2.4 Detailed Design, 36

2.2.5 Manufacturing a Prototype, 36

2.2.6 Tracheal Stent, 38

2.2.7 Conceptual Design, 39

2.2.8 Embodiment Design and Detail Design, 43

2.2.9 Manufacturing a Prototype, 45

2.3 Conclusions, 45

References, 46

3 Forming Applications 49
Karen Bayl³n, Elisabetta Ceretti, Claudio Giardini, and Maria Luisa Garcia-Romeu

3.1 Forming, 49

3.2 Typical Process Parameters, 52

3.2.1 Temperature, 52

3.2.2 Flow Stress, 53

3.2.3 Strain, 53

3.2.4 Strain Rate, 54

3.2.5 Tribology and Micro-Tribology, 54

3.3 Manufacturing Process Chain, 55

3.3.1 Manufacture of Alloys and Raw Materials, 55

3.3.2 Forming, 56

3.3.3 Machining and Finishing, 56

3.3.4 Coating, 56

3.3.5 Packaging and Sterilization, 56

3.4 Implantable Devices, 56

3.5 Bone Implants, 57

3.5.1 External Fracture Fixation, 57

3.5.2 Artificial Joint Replacement, 58

3.5.3 Spinal Implants, 68

3.5.4 Craniomandibular Implants, 68

3.5.5 Dental Implants, 71

3.6 Other Biomedical Applications, 73

References, 74

4 Laser Processing Applications 79
Tu¢grul -zel, Joaquim De Ciurana Gay, Daniel Teixidor Ezpeleta, and Luis Criales

4.1 Introduction, 79

4.2 Microscale Medical Device Applications, 80

4.3 Processing Methods for Medical Device Fabrication, 82

4.4 Biomaterials Used in Medical Devices, 86

4.5 Microjoining of Similar and Dissimilar Materials, 86

4.6 Laser Micromachining for Microfluidics, 89

4.7 Laser Micromachining for Metallic Coronary Stents, 92

References, 94

5 Machining Applications 99
Tu¢grul -zel, Elisabetta Ceretti, Thanongsak Thepsonthi, and Aldo Attanasio

5.1 Introduction, 99

5.2 Machinability of Biocompatible Metal Alloys, 102

5.3 Surfaces Engineering of Metal Implants, 104

5.4 Wear and Failure of Metal Implants, 105

5.5 Micromilling-Based Fabrication of Metallic Microchannels for Medical Devices, 106

5.6 Machining-Based Fabrication of Polymeric Microneedle Devices, 109

5.7 A Case Study: Milling-Based Fabrication of Spinal Spacer Cage, 110

5.7.1 Degenerative Disc Disease, 112

5.7.2 Intervertebral Spinal Spacers, 113

5.7.3 Prototype Fabrication Using Milling Process, 115

References, 118

6 Inkjet- and Extrusion-Based Technologies 121
Karla Monroy, Lidia Seren³, Joaquim De Ciurana Gay, Paulo Jorge B¡rtolo, Jorge Vicente Lopes Da Silva, and Marco Domingos

6.1 Introduction, 121

6.2 Inkjet Technology, 124

6.2.1 Inkjet 3D Printing Technology, 125

6.2.2 Materials in Inkjet-Based Technologies, 128

6.2.3 Inkjet Printing Methods, 130

6.2.4 Inkjet Printing Systems: Processes and Machines, 131

6.2.5 Medical Applications of Inkjet Technology, 135

6.3 Material Extrusion Technology, 139

6.3.1 Material Extrusionâ"General Principles, 139

6.3.2 Extrusion-Based Technologies, 144

6.3.3 Medical Applications of Extrusion-Based Systems, 153

References, 156

7 Certification for Medical Devices 161
Corrado Paganelli, Marino Bindi, Laura Laffranchi, Domenico Dalessandri, Stefano Salgarello, Antonio Fiorentino, Giuseppe Vatri, and Arne Hensten

7.1 Introduction, 161

7.2 The Medical Devices Approval, Registration, or Certification, 163

7.3 The Premarket Key Activity: The Demonstration of the Conformity to the Safety and Performance Requirements, 163

7.4 The Postmarket Key Activity: The Surveillance, 165

7.5 The Role of the Quality Management Systems, 165

7.6 The Verification and the Auditing, 166

7.7 The Role of the Standards, 167

7.8 Examples of Approbation/Certification Roads in Some World Areas, 168

7.8.1 European Union, 168

7.8.2 United States of America, 168

7.8.3 Japan, 168

7.8.4 Australia, 169

7.8.5 Brazil, 169

7.8.6 Canada, 169

7.9 In-Depth Studies, 170

7.9.1 Essentials of Safety and Performance Principles, 170

7.9.2 Essentials of the Risk Management, 174

7.9.3 Essentials of the Nonclinical Evaluation, 175

7.9.4 Essentials of the Clinical Evaluation, 178

References, 181

INDEX 183