ABSTRACT

 

This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated.

Features

  • Provides updated material as needed to each chapter
  • Incorporates new examples and applications within each chapter
  • Discusses new material related to entrepreneurship, clinical trials and CRISPR
  • Relates critical new information pertaining to FDA regulations.
  • Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments
  • Presents multiple case examples of entrepreneurship in this field
  • Addresses multiple safety and ethical concerns for the design of medical devices and processes

chapter 4|19 pages

Product Definition

chapter 5|21 pages

Product Documentation

chapter 6|13 pages

Product Development

chapter 7|31 pages

Hardware Development Methods and Tools

chapter 8|22 pages

Software Development Methods and Tools

chapter 9|26 pages

Human Factors

chapter 10|17 pages

Industrial Design

chapter 11|18 pages

Biomaterials and Material Testing

chapter 12|26 pages

Risk Analysis—Devices and Processes

chapter 13|19 pages

Testing

chapter 14|17 pages

Analysis of Test Data

chapter 16|22 pages

The FDA and Devices

chapter 18|29 pages

Biological Engineering Designs

chapter 19|28 pages

International Regulations and Standards

chapter 20|18 pages

Intellectual Property

Patents, Copyrights, Trade Secrets, and Licensing

chapter 21|11 pages

Manufacturing and Quality Control

chapter 22|14 pages

Miscellaneous Issues

chapter 23|11 pages

Professional Issues

chapter 24|11 pages

Concept to Product?