Intro -- Table of Contents -- List of Figures and Tables -- Acronyms and Abbreviations -- Preface -- Part I Unique Challenges in Medical Product Development -- 1 Pushing the Pipeline -- 2 Healthcare in the United States -- 3 It's Not Your Father's FDA -- 4 Classifying Medical Products -- 5 Product Liability and Product Development -- Part II Bringing a New Medical Product to Market -- 6 Overview of the Approval Processes for Drugs, Biologics, and Medical Devices -- 7 Quality by Design -- 8 Designing-Out Disaster: Risk Analysis -- 9 Recalls, Withdrawals, and Revocations -- 10 Human Factors and Usability Engineering -- 11 Is It Safe and Does It Work? -- 12 How Much Is the Product Really Worth? -- Part III Product Development Planning -- 13 Models and Metaphors -- 14 Components of Product Development Planning -- 15 Components of Product Development Planning -- 16 Components of Product Development Planning -- 17 Components of Product Development Planning -- 18 Better Double-Check That -- 19 Where Do We Go From Here? -- Appendix Resources -- Endnotes -- Glossary -- Index.
