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