Biomedical Devices: Design, Prototyping, and Manufacturing

Book Preface

There has been an increasing demand for biomedical devices including various instruments,apparatuses, implants, in vitro reagents, and similar articles to diagnose, prevent, or treat diseases, improve human health, prolong human life, and recover from serious injuries. Biomedical devices that we utilize are not only continuously getting smaller and more effective but are also designed with more customized functionalities. In response to that demand, new design innovations, new materials, and prototypes of novel medical devices have been introduced on a regular basis. Design, prototyping, and manufacturing techniques for these materials and designs have also been continuously developing in parallel to the needs in biomedical device demands. There have been a large number of books written about design and manufacturing of various products but biomedical device manufacturing remains less covered than other well-known microelectronics and consumer products.

This book brings authors from institutions around the world, perhaps one of the few wide-ranging books on manufacturing processes for medical devices with coverage of various materials including metals and polymers. The book aims to reach audiences such as practicing engineers who are working in medical device industry, students in the biomedical device manufacturing courses, and faculty/researcherswho are conducting research in medical device design, prototyping, and manufacturing.

Chapter 1, written by Joaquim De Ciurana, Tu˘grul Özel, and Lidia Serenó, provides an introduction with classification and regulation specification about medical
devices with sample manufacturing processes and applications. Chapter 2, prepared by Inés Ferrer Real, Jordi Grabalosa, Alex Elias-Zuniga, and Ciro Rodriguez, summarizes design issues and methodologies applicable to well-known medical device prototypes. Chapter 3, prepared by Karen Baylón, Elisabetta Ceretti, Claudio Giardini, and M. Luisa Garcia-Romeu, describes the issues in modeling and analysis for forming processes along with the comparison of different modeling approaches. Chapter 4, prepared by Tu˘grul Özel, Joaquim De Ciurana, Daniel Teixidor, and Luis Criales, describes some of the manufacturing processes based on laser processing with several examples for medical devices. Chapter 5, prepared by Tu˘grul Özel, Elisabetta Ceretti, Thanongsak Thepsonthi, and Aldo Attanasio, discusses machining applications and manufacturing processes to be used for medical devices made out of metals and plastics. Extrusion- and inkjet-based processes and applications are presented in Chapter 6, which was prepared by KarlaMonroy, Lidia Serenó, Joaquim De Ciurana, Paulo Jorge Bártolo, Jorge Da Silva, Marco Domingos, Corrado Paganelli, Marino Bindi, Laura Laffranchi, Domenico Dalessandri, Stefano Salgarello, Antonio Fiorentino, Giuseppe Vatri, and Arne Hensten prepared the Chapter 7 on certification of medical devices.

We thank all the authors who contributed to this book. We also extend our thanks to Ms Anita Lekhwani and Ms Sumathi Elangovan of John Wiley who assisted us in all stages of preparing this book for the publication.

T. Özel, P. Bártolo, E. Ceretti, J. Ciurana Gay,
C. A. Rodríguez, J. V. Lopes Da Silva
June 2016