In this webinar we will scrutinize quality and test solutions used in engineering for medical devices. With a focus on practical application and balancing the tradeoffs when using mainstream tools, we'll provide you with actionable information to optimize your approach to quality and testing in your medical devices.

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
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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

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Usability Design to Minimize Use Errors
Usability for Quality in Medical Devices
● Prioritizing Safety over Intuitive/User-friendly
● Quality relates to Use Errors
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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
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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
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9. Integrated Computer Solutions Inc. www.ics.com
Architecture for Quality

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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
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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)
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Architecture Organization - Tiered Architecture
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Dependency Inversion
Error injection/SOLID – diagram
Make it easier to test high-level modules by replacing low level
modules with simulators
Loose coupling
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“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’
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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>
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Code Analyzers

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Code Analyzers
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• 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

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Code Analyzers - Drawbacks
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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