Design of Biomedical Devices and Systems, Second Edition

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eBook (VitalSource)
ISBN 9781439889732
Cat# KE14631



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  • Provides comprehensive coverage of all major design principles
  • Includes updates to every chapter
  • Emphasizes a practical, hands-on approach to device design
  • Introduces the need for documentation techniques and requirements in the generation of a design team
  • Discusses the legal ramifications of medical device development and failure
  • Gives a summary of key ways to protect intellectual property
  • Reviews nine case studies
  • Captures snapshots of popular design areas, present and future



The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This edition of a bestselling textbook utilizes a strong design perspective to provide designers with a thorough overview of the field, including topics related to databases, process analysis, and device improvement.

Covers All Necessary Design Aspects for Advanced Biomedical Projects

Designed primarily for senior bioengineering students in the formative stages of planning their design project, Design of Biomedical Devices and Systems is also beneficial to graduate students in the field and practitioners working with medical devices. This standard-setting resource includes:

  • A variety of open-ended design problems and examples
  • An overview of device definitions and reliability
  • A discussion of testing and hardware verification and validation principles
  • Detailed photographs and illustrations within each chapter

Systematic approaches to device development and maintenance are mandated to ensure safe and effective devices for the patient, an economical and competitive success for the manufacturer, and a reliable, cost-effective investment for the user. This authoritative textbook answers the call.

A solutions manual is available for instructors wishing to convert this reference to classroom use.

Table of Contents

Introduction to Biomedical Engineering Design. Fundamental Design Tools. Design Team Management, Reporting, and Documentation. Product Definition. Product Documentation. Product Development. Hardware Development Methods and Tools. Software Development Methods and Tools. Human Factors. Industrial Design. Biomaterials and Material Testing. Safety Engineering: Devices and Processes. Testing. Analysis of Test Data. Reliability and Liability. Food and Drug Administration. Regulations and Standards. Licensing, Patents, Copyrights, and Trade Secrets. Manufacturing and Quality Control. Miscellaneous Issues. Product Issues. Professional Issues. Design Case Studies. Future Design Issues.

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