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