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Sub-Header Text
Welcome
1
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.
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
Quality and Test in Medical Devices
1. Part 1 - Recap
2. Part 2 - Test Methods, Pros, Cons
3. The complete picture Quality and Test
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Part 1 Recap
1. Usability to systematically reduce Use Errors through product design - impacts quality
2. Architecture for quality - maintainable, testable, extensible, reliable, available
a. Tiered layers - visibility / access
b. Error injection - difficult to test sub-systems
c. Dependency inversion - simulators and visibility
3. Code analyzers
a. A quality tool, with tradeoffs
b. Necessary but not sufficient (for complex projects)
Usability and Architecture for Quality
5
Part 2
➢ Test Canon
● Automated GUI testing
● System testing
● Integration testing
● Unit tests
➢ High-Value testing
○ Key goals
○ Example
➢ Verification vs. test canon
➢ Software “Reliability"
Pros and Cons of Testing
6
Automated UI
Testing
Page #
Using a 3rd party application to automate mouse clicks on a GUI (Graphical User Interface)
Test tools manage scripts and collections and support automation
Good for:
- Stable User Interfaces (not undergoing changes)
- Enduring value - runs ‘for free’
- Functional/system/black-box testing
Automated Graphical
User Interface Testing
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The document discusses quality assurance and testing in software development. It recommends establishing a quality assurance framework that incorporates source code management, continuous integration, code reviews, and continuous inspection tools like SonarQube. This helps automate the development process, reduce technical debt, and prevent bugs by finding and fixing issues early. Tracking key metrics also allows measuring the costs of quality problems versus prevention activities.

Challenges
- Brittle - Superficial changes to UI can cause tests to fail
- Test strategy - create modular/reusable tests that can be daisy-chained
- No variability - tests the same thing over and over
- Mostly tells you something changed
- Changes system - additional process running on system with threading considerations
- i.e. a graphic bug example (triangles)
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● Are all system behaviors available from the UI?
System Testing
● May require additional test software/framework (i.e. LIS, Cloud services)
● Focuses on positive and negative test cases
● Can be harder to automate
Both
Are tested vs. product requirements
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Why integration testing is important
- Behavior obscured by system
complexity
- FDA language indicating that functional
testing (Black box), is not sufficient as it
does not exercise hidden dependencies
- Rigorously test behavior for each block
and each interface
- Essential for large or complex products
Integration Testing
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Pro
- Essential, irreplaceable form of test for
a complex system
Con
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Unit Tests
Page #
Unit Tests
Background
- The smallest unit of test
- Software functions that call product functions
- They usually are numerous, multiple test functions for
a single product function. Executed by a framework in
an automated build/test sequence.
- Necessary, but far from adequate
As valuable as we thought?
15
Unit Tests
Pros
- Finds bugs early, at check-in
- Easily automated - Part of Continuous Integration
- Automated coverage metrics
- Enduring value
- Mature tool set (Google Test, xUnit, Mocha)
- Gold standard
Cons
- Increases initial development effort
- Finds few bugs
- Static
- Obvious/trivial
- Low value/effort ratio
- Small code changes can take much longer
- False confidence in code quality
Pros / Cons?
16
Commonly seen:
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a bug
- Unit test code > product source
code - making changes difficult
- High effort to get the last 10%
coverage - with little apparent
return
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Unit Tests
Keep it light
Don’t try for 100% everywhere
Differentiate highly critical vs. non-critical
Pin down the corners vs. exhaustive testing
Don’t:
Add high levels of test if product in flux
Add trivial testing to improve code coverage metrics
Best applied to
Stable products
When losing experienced staff
Sophisticated/complex designs
Automation: Continuous Integration, automated emails
Best practices
Page #
Best practice
Non-trivial tests written for stable
products with low staffing levels in an
automated environment
Worst practice
Simple tests written for 100% code
coverage on products undergoing change
TL;DR
High Value Testing
Page #
➢ Analyze software sub-components for criticality
○ Comes from IEC 62304: risk based
analysis for each software
sub-component
○ Adjust your process according to risk
➢ Allows you to discriminate between critical
sub-systems and non-critical sub-systems
➢ Overall safety class = MAX(each functional
aspect)
High Value Testing
19
C B C C B C C A B A C A
Key goals
1) Balance test resources around criticality of
component to Intended Use, Safety, Efficacy
2) Minimize development overhead
3) Minimize regulatory burden
Example
- “Offline Data Access” omits unit, integration,
system testing
Pro
- Less budget overall
- More budget on critical areas
Con
- Expertise: More complicated to plan and apply
- Hard to keep track of →Test Plan
High Value Testing
20
A
C B C C B C C A B C A

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➢ Test vs. Verification
➢ Reliability
Page #
Quality
team
V&V
team
Engineering
Quality Assurance
- Confirm process
- Checking that SDP steps were followed
- Issuing/processing CAPAs
Engineering Test Engineer
- Test automation (scripts, CI integration)
- Ad-hoc testing
- Smoke testing
- Build management
Verification Test Engineer
- Formal test protocol writing
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- Test coverage
- Requirement focus
Validation Test
- Formal test protocol writing
- Formal test protocol execution
- Clinical focus
- Statistical test treatment
HF/UE Test
Engineer
- Summative test
HF/UE Test
Engineer
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Engineering
Vs
Quality
Developer
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Quality driven
Plan → Review → Report
Plan
Accounts for engineering tests
Analyze/Review
Determines outcome
Report
Formally documents
Engineering driven
- Development process
- Includes ad-hoc
Engineering Test vs. Verification & Validation
● Software is logical not physical so traditional concepts of failure
don’t apply
○ Mechanical or electrical systems have Bathtub failure curves
● Software Reliability is a nuanced concept different from Software
Quality
○ Reliability is Software Quality over time
○ i.e. How long has the software been meeting it’s requirements
● Reliability
○ Considers Total Inputs vs Total Outputs
○ Tests a sample of Total Inputs
○ Probability = Number failing cases / Total cases
○ Testing types: Feature/Load/Regression test
○
● Takeaway:
○ Reliability is a sample based, predictive metric different from
QA/QC/Test
○ A complete, quantitative, system for assessing software
Software Reliability
23
Tying it together:
Part 1 & 2
Quality vs. Test
Page #

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Quality → Test
What’s the relationship between quality and test?
Quality as an outcome, Test as a method?
Can you test quality into a product?
Usability
Use Errors
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Enhancing Quality and Test in Medical Device Design - Part 2.pdf

  • 2. 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. 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. Quality and Test in Medical Devices 1. Part 1 - Recap 2. Part 2 - Test Methods, Pros, Cons 3. The complete picture Quality and Test Page #
  • 5. Part 1 Recap 1. Usability to systematically reduce Use Errors through product design - impacts quality 2. Architecture for quality - maintainable, testable, extensible, reliable, available a. Tiered layers - visibility / access b. Error injection - difficult to test sub-systems c. Dependency inversion - simulators and visibility 3. Code analyzers a. A quality tool, with tradeoffs b. Necessary but not sufficient (for complex projects) Usability and Architecture for Quality 5
  • 6. Part 2 ➢ Test Canon ● Automated GUI testing ● System testing ● Integration testing ● Unit tests ➢ High-Value testing ○ Key goals ○ Example ➢ Verification vs. test canon ➢ Software “Reliability" Pros and Cons of Testing 6
  • 8. Using a 3rd party application to automate mouse clicks on a GUI (Graphical User Interface) Test tools manage scripts and collections and support automation Good for: - Stable User Interfaces (not undergoing changes) - Enduring value - runs ‘for free’ - Functional/system/black-box testing Automated Graphical User Interface Testing 8 Lambda Test Selenium AutoHotKey Squish Test Complete Cypress
  • 9. Challenges - Brittle - Superficial changes to UI can cause tests to fail - Test strategy - create modular/reusable tests that can be daisy-chained - No variability - tests the same thing over and over - Mostly tells you something changed - Changes system - additional process running on system with threading considerations - i.e. a graphic bug example (triangles) Automated User Interface Testing 9 Lambda Test Selenium AutoHotKey Squish
  • 11. UI vs. System testing → same? ● Depends on architecture and functionality of the UI ● Are all system behaviors available from the UI? System Testing ● May require additional test software/framework (i.e. LIS, Cloud services) ● Focuses on positive and negative test cases ● Can be harder to automate Both Are tested vs. product requirements System Testing 11
  • 13. Why integration testing is important - Behavior obscured by system complexity - FDA language indicating that functional testing (Black box), is not sufficient as it does not exercise hidden dependencies - Rigorously test behavior for each block and each interface - Essential for large or complex products Integration Testing 13 Pro - Essential, irreplaceable form of test for a complex system Con - Labor intensive - Time-consuming
  • 15. Unit Tests Background - The smallest unit of test - Software functions that call product functions - They usually are numerous, multiple test functions for a single product function. Executed by a framework in an automated build/test sequence. - Necessary, but far from adequate As valuable as we thought? 15
  • 16. Unit Tests Pros - Finds bugs early, at check-in - Easily automated - Part of Continuous Integration - Automated coverage metrics - Enduring value - Mature tool set (Google Test, xUnit, Mocha) - Gold standard Cons - Increases initial development effort - Finds few bugs - Static - Obvious/trivial - Low value/effort ratio - Small code changes can take much longer - False confidence in code quality Pros / Cons? 16 Commonly seen: - Low value unit tests that rarely find a bug - Unit test code > product source code - making changes difficult - High effort to get the last 10% coverage - with little apparent return - But,... still essential
  • 17. Unit Tests Keep it light Don’t try for 100% everywhere Differentiate highly critical vs. non-critical Pin down the corners vs. exhaustive testing Don’t: Add high levels of test if product in flux Add trivial testing to improve code coverage metrics Best applied to Stable products When losing experienced staff Sophisticated/complex designs Automation: Continuous Integration, automated emails Best practices Page # Best practice Non-trivial tests written for stable products with low staffing levels in an automated environment Worst practice Simple tests written for 100% code coverage on products undergoing change TL;DR
  • 19. ➢ Analyze software sub-components for criticality ○ Comes from IEC 62304: risk based analysis for each software sub-component ○ Adjust your process according to risk ➢ Allows you to discriminate between critical sub-systems and non-critical sub-systems ➢ Overall safety class = MAX(each functional aspect) High Value Testing 19 C B C C B C C A B A C A
  • 20. Key goals 1) Balance test resources around criticality of component to Intended Use, Safety, Efficacy 2) Minimize development overhead 3) Minimize regulatory burden Example - “Offline Data Access” omits unit, integration, system testing Pro - Less budget overall - More budget on critical areas Con - Expertise: More complicated to plan and apply - Hard to keep track of →Test Plan High Value Testing 20 A C B C C B C C A B C A
  • 21. ➢ Test vs. Verification ➢ Reliability Page #
  • 22. Quality team V&V team Engineering Quality Assurance - Confirm process - Checking that SDP steps were followed - Issuing/processing CAPAs Engineering Test Engineer - Test automation (scripts, CI integration) - Ad-hoc testing - Smoke testing - Build management Verification Test Engineer - Formal test protocol writing - Formal test protocol execution - Test coverage - Requirement focus Validation Test - Formal test protocol writing - Formal test protocol execution - Clinical focus - Statistical test treatment HF/UE Test Engineer - Summative test HF/UE Test Engineer - Formative test Engineering Vs Quality Developer - Unit tests - Ad-hoc testing Quality driven Plan → Review → Report Plan Accounts for engineering tests Analyze/Review Determines outcome Report Formally documents Engineering driven - Development process - Includes ad-hoc Engineering Test vs. Verification & Validation
  • 23. ● Software is logical not physical so traditional concepts of failure don’t apply ○ Mechanical or electrical systems have Bathtub failure curves ● Software Reliability is a nuanced concept different from Software Quality ○ Reliability is Software Quality over time ○ i.e. How long has the software been meeting it’s requirements ● Reliability ○ Considers Total Inputs vs Total Outputs ○ Tests a sample of Total Inputs ○ Probability = Number failing cases / Total cases ○ Testing types: Feature/Load/Regression test ○ ● Takeaway: ○ Reliability is a sample based, predictive metric different from QA/QC/Test ○ A complete, quantitative, system for assessing software Software Reliability 23
  • 24. Tying it together: Part 1 & 2 Quality vs. Test Page #
  • 25. Quality → Test What’s the relationship between quality and test? Quality as an outcome, Test as a method? Can you test quality into a product? Usability Use Errors Prevent unintended behaviors Architecture Separation Clear responsibilities Access / Visibility Prevent unintended functionality Test canon (unit, integration, system, UI) Quality/Test relationship 25 Quality Assurance Quality Control Testing Prevent Defects Correct Defects Detect Defects