Quality and Test in Medical Device Design - Part 1.pdf
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Integrated Computer Solutions Inc. (ICS), established in 1987 and headquartered in Waltham, MA, provides software solutions and services for medical device development, including UX design, custom software, and compliance with medical standards. The document discusses key elements for enhancing quality in medical device design, such as usability design, architecture principles, and testing strategies. ICS emphasizes the importance of addressing use errors, systematic treatment of risks, and maintaining scalable architecture to ensure the reliability and effectiveness of medical devices.
Quality and Test in Medical Device Design - Part 1.pdf
- 1. Integrated Computer Solutions Inc. www.ics.com 1
- 2. Integrated Computer Solutions Inc. www.ics.com About ICS Established in 1987, Integrated Computer Solutions, Inc. (ICS) delivers innovative software solutions with a full suite of services to accelerate development of successful next-gen products. ICS is headquartered outside Boston in Waltham, Mass. with offices in California, Canada and Europe. Currently 160+ people.
- 3. Integrated Computer Solutions Inc. www.ics.com www.ics.com Delivering a Full Suite of Medtech Services ● IEC 62366-UX/UI Design ● Custom Frontend & Backend Software Development ● Development with IEC 62304-Compliant Platform ● Low-code Tools that Convert UX Prototype to Product ● Medical Device Cybersecurity ● AWS and Azure Cloud Services and Analytics ● ISO 14971-Compliant Hazard Analysis ● Software Verification Testing ● Digital Twins for Training and Simulation ● Complimentary Software Technology Assessments
- 4. Integrated Computer Solutions Inc. www.ics.com Enhancing Quality and Test in Medical Device Design Webinar Part 1 of 2 Part 1 1. Usability Design for Quality 2. Architecture design a. Tiered b. Error injection c. Solid’s dependency inversion d. Loose coupling 3. Code analyzers 4 Part 2 1. Automated testing a. Unit tests with coverage metrics to promote code stability b. Automated User Interface testing to shorten defect remediation cycles c. Product verification 2. Tracing requirements to design a. Requirement coverage analysis b. Verification test protocols
- 5. Integrated Computer Solutions Inc. www.ics.com Usability for Quality
- 6. Integrated Computer Solutions Inc. www.ics.com Usability Design to Minimize Use Errors Usability for Quality in Medical Devices ● Prioritizing Safety over Intuitive/User-friendly ● Quality relates to Use Errors 6
- 7. Integrated Computer Solutions Inc. www.ics.com Usability Design to Minimize Use Errors (Cont’d) User Error vs. Use Error ● User Error – is a user problem ● Use Error – is a device characteristic “Safe and Effective” ○ “Safe and effective use of a medical device means that users do not make errors that lead to injury and they achieve the desired medical treatment. If safe and effective use is not achieved, use error has occurred. Why and how use error occurs is a human factors concern” (FDA Glossary of Medical Devices) Use Error fixes: Training? Labeling? Who reads anymore? Use Errors need to be fixed 7
- 8. Integrated Computer Solutions Inc. www.ics.com Usability Design to Minimize Use Errors (Cont’d) Context is critical for Use Errors ● Device intent + use environment + user types Use Errors FDA wants Systematic treatment of Use Errors ● Over-familiar stakeholders tend to guess omissions ● Defined method to identify Use Errors ● Use Errors 🡪 Mitigations 🡪 Residual Risk 🡪 Test Effectiveness ● IEC 62366 - Application of usability engineering to medical devices 8
- 9. Integrated Computer Solutions Inc. www.ics.com Architecture for Quality
- 10. Integrated Computer Solutions Inc. www.ics.com How Architecture Impacts Device Quality Maintainable, testable, extensible, reliable, available architecture Why maintainable/extensible impacts quality? ● Things misbehave – Transparency (logging, simulators), Debuggability (determinism, traceability, separation of concerns) ● Things change – Avoid inadvertent change, minimize change ● Things need to be tested - Testing can be hard 10
- 11. Integrated Computer Solutions Inc. www.ics.com Architecture Principles “If you think good architecture is expensive, try bad architecture!” — Brian Foote & Joseph Yoder How Architecture helps with Quality through application of principles ● SOLID – a series of principles to achieve quality through separation and structured relationships ● Single-responsibility principle (SRP) ● Open-closed principle (OCP) ● Liskov substitution principle (LSP) ● Interface-segregation Principle (ISP) ● Dependency-inversion principle (DIP) 11
- 12. Integrated Computer Solutions Inc. www.ics.com Architecture Organization - Tiered Architecture 12
- 13. Integrated Computer Solutions Inc. www.ics.com Dependency Inversion Error injection/SOLID – diagram Make it easier to test high-level modules by replacing low level modules with simulators Loose coupling 13 “Would you solder a lamp directly to the electrical wiring in a wall?”
- 14. Integrated Computer Solutions Inc. www.ics.com Architecture for Test ● Make it easy to test ● Software can be (relatively) inexpensive to test ● Hardware is usually expensive to test ● Person hours – manual test, manual configuration ● Test platforms/equipment – engineering costs, storage costs, configurations ● Automated tests run ‘for free’ 14
- 15. Integrated Computer Solutions Inc. www.ics.com Architecture Tradeoffs Downsides ● Non-trivial to apply ● Correct application requires architectural expertise ● Has to be enforced on every check-in ● A lot of segregation and isolation within the code - may not be needed ● Bigger code ● Distributed code - harder to comprehend without detailed documentation <for Medical Devices, still worth it, liability, recalls, patient health> 15
- 16. Integrated Computer Solutions Inc. www.ics.com Code Analyzers
- 17. Integrated Computer Solutions Inc. www.ics.com Code Analyzers 17 • Static • Looks at syntax and conventions used in source code to highlight potential problems • Good for enforcing a code style, structure, conventions • Most tools are static analysis tools - easier than dynamic • Dynamic • Runs the application and looks for issues • Can use statistical and inferential approaches • Some have a management system for issues found Upshot: Some solution needed - treat as a requirement Popular tools • Valgrind • Coverity • BoundsChecker • Clang • PC-Lint • CPPLint
- 18. Integrated Computer Solutions Inc. www.ics.com Code Analyzers - Drawbacks 18 Static: • Effort intensive • Large number of rules to configure • Large number of findings, most aren’t significant • (1000s to 100,000s) Dynamic: • Usually requires inserting new code into your code (which changes how your code runs!) • Large number of findings • Sophisticated ones can be expensive Even the best still won’t find that deep-intermittent bug
- 19. Integrated Computer Solutions Inc. www.ics.com Recap: Enhancing Quality and Test in Medical Device Design Webinar Part 1 of 2 Part 1 1. Usability Design for Quality 2. Architecture design a. Tiered b. Error injection c. Solid’s dependency inversion d. Loose coupling 3. Code analyzers 19 Part 2 1. Automated testing a. Unit tests with coverage metrics to promote code stability b. Automated User Interface testing to shorten defect remediation cycles c. Product verification 2. Tracing requirements to design a. Requirement coverage analysis b. Verification test protocols
- 20. Integrated Computer Solutions Inc. www.ics.com Questions?
- 21. Integrated Computer Solutions Inc. www.ics.com Thank You www.ics.com