Introduction to Medical Software
Foundations for Digital Health, Devices, and Diagnostics

A concise and accessible overview of the design, implementation and management of medical software.

Xenophon Papademetris (Author), Ayesha N. Quraishi (Author), Gregory P. Licholai (Author)

9781316514993, Cambridge University Press

Hardback, published 5 May 2022

338 pages
25.2 x 19.3 x 2.2 cm, 0.87 kg

Providing a concise and accessible overview of the design, implementation and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical software lifecycle process ; accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering and healthcare bring readers up-to-speed; six cautionary real-world case studies illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs.

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.

Subject Areas: Software Engineering [UMZ], Industrial applications of scientific research & technological innovation [PDG], Biomedical engineering [MQW], Forensic medicine [MMQ], Medical ethics & professional conduct [MBDC], Medical & healthcare law [LNTM], Entrepreneurship [KJH]