Biomedical Engineering Design,
Edition 1
By Joseph Tranquillo, Ph.D., Jay Goldberg, Ph.D., PE and Robert Allen, Ph.D., PE

Publication Date: 24 May 2022

*Textbook and Academic Authors Association (TAA) Most Promising New Textbook Award Winner, 2024*

Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device.

Key Features

  • Covers subject matter rarely addressed in other BME design texts, such as packaging design, testing in living systems and sterilization methods
  • Provides instructive examples of how technical, marketing, regulatory, legal, and ethical requirements inform the design process
  • Includes numerous examples from both industry and academic design projects that highlight different ways to navigate the stages of design as well as document and communicate design decisions
  • Provides comprehensive coverage of the design process, including methods for identifying unmet needs, applying Design for ‘X’, and incorporating standards and design controls
  • Discusses topics that prepare students for careers in medical device design or other related medical fields
About the author
By Joseph Tranquillo, Ph.D., Biomedical Engineering Department, Bucknell University, Lewisburg, PA, USA; Jay Goldberg, Ph.D., PE, Department of Biomedical Engineering, Marquette University, and the Medical College of Wisconsin, Milwaukee, WI, USA and Robert Allen, Ph.D., PE, Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine, New York
Table of Contents

1. Introduction
2. Design Teams and Project Management
3. Defining the Medical Problem
4. Defining the Engineering Problem
5. Generating Solution Concepts and Preliminary Designs
6. Selecting a Solution Concept
7. Prototyping
8. Detailed Design
9. Testing for Design Verification and Validation
10. Testing in Living Systems
11. Medical Device Standards and Design Controls
12. Regulatory Requirements
13. Ethics in Medical Device Design
14. Beyond Design: The Engineer's Role in Design Transfer, Commercialization, and Post Market Surveillance
15. Collaborating on Multifunctional Teams to Commercialize Medical Products

Book details
ISBN: 9780128164440
Page Count: 528
Retail Price : £71.95

9780128092637; 9780128119846; 9780123749796


Biomedical engineering students in capstone or junior and lower level design courses; practicing engineers in industry who are searching for a more appropriate, up-to-date design process that may not currently be used in their organization

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