An overview of medical software design, implementation and management. Covers technical, commercial and regulatory issues and includes cautionary real-world case studies. For undergraduates in biomedical engineering, electrical engineering, computer science, junior software engineers in the medical device industry, and digital health entrepreneurs.
An overview of medical software design, implementation and management. Covers technical, commercial and regulatory issues and includes cautionary real-world case studies. For undergraduates in biomedical engineering, electrical engineering, computer science, junior software engineers in the medical device industry, and digital health entrepreneurs.
Xenophon Papademetris is Professor of Radiology and Biomedical Imaging, and Biomedical Engineering at Yale University whose research focuses on biomedical image analysis and software development. He has over twenty years of experience in medical software design.
Inhaltsangabe
Preface Part 1. Regulatory, Business and Management Background: 1. Introduction to medical software 2. The FDA and software 3. Operating within a healthcare system 4. Quality management systems 5. Risk management 6. Taking an idea to market: understanding the product journey 7. Medical software applications and growth drivers Part II. Scientific and Technical Background: 8. Mathematical background 9. Topics in software engineering Part III. An Example Medical Software Life Cycle Process: 10. The overall process 11. Identifying user needs 12. The system requirements specification 13. The software design document 14. Software construction and testing and verification 15. Software validation 16. Deployment, maintenance and decommissioning Part IV. Case Studies: 17. Therac-25: software that killed 18. Mars Climate Orbiter: lost without a trace 19. Healthcare.gov: the failed launch of a critical webpage 20. The 2020 Iowa Caucus app: an unreliable app that caused national embarrassment 21. The Boeing 737-MAX disasters: using software to fix hardware problems 22. The averted Y2K crisis: successful crisis and risk management References Index.
Preface Part 1. Regulatory, Business and Management Background: 1. Introduction to medical software 2. The FDA and software 3. Operating within a healthcare system 4. Quality management systems 5. Risk management 6. Taking an idea to market: understanding the product journey 7. Medical software applications and growth drivers Part II. Scientific and Technical Background: 8. Mathematical background 9. Topics in software engineering Part III. An Example Medical Software Life Cycle Process: 10. The overall process 11. Identifying user needs 12. The system requirements specification 13. The software design document 14. Software construction and testing and verification 15. Software validation 16. Deployment, maintenance and decommissioning Part IV. Case Studies: 17. Therac-25: software that killed 18. Mars Climate Orbiter: lost without a trace 19. Healthcare.gov: the failed launch of a critical webpage 20. The 2020 Iowa Caucus app: an unreliable app that caused national embarrassment 21. The Boeing 737-MAX disasters: using software to fix hardware problems 22. The averted Y2K crisis: successful crisis and risk management References Index.
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