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“Practical usability testing of a
molecular diagnostic system”
“it’s fun”
Romanian Testing Conference 2015!
May 2015
Patrick Duisters
1.0
Improve Quality Services B.V., The Netherlands 2
Patrick Duisters
● >15 years in Software Testing
& Quality Assurance
● Administrative, Technical, Medical,
Financial, Governmental, Automotive
● Test Consultant, Trainer, Auditor
● Certification & accreditation: Full CTEL
● [email protected] @PatrickDuisters www.improveqs.nl
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Experiences & Observation
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Agenda
● Context
● Usability & Standards
● Usability Program
● Deployment
● Results & Conclusion
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Context: Product…
Molecular Diagnostics Platform: IVD: e.g. medical DNA analysis
● ‘Sample in – Result out’
● Reduced lead time
● Innovative & totally new
● EU & US
● Verification & Validation in a regulated environment
● Medical, EU & US
● Regulations & Regulatory bodies: i.e. FDA
● Risk management mandatory
● Norms & standards:
− ISO14971: MDs - Application of Risk Management to Medical
Devices
− ISO 62304: Medical device software - Software life cycle
processes
− ISO 62366: Medical devices – Application
of usability engineering to medical devices
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Context: Environment…
What is Usability?
Usability: characteristic of the USER INTERFACE that establishes
EFFECTIVENESS, EFFICIENCY, EASE of USER LEARINING and
user SATISFACTION (ISO 62366:2007)
●User Friendliness
●Learnability
●Error Prevention
●Iterative Development & Testing
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Elements of ISO 62366
Usability Program
● Reviews &
Testing
● Usability Testing
& survey
● Observations
& survey
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Development
Verification
Validation
Deployment: Development
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● Heuristic Analysis
● Exploratory Testing
Development: Heuristic Analysis
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● Kick-off
● Logging template
● Analysis
● Start early / include!
http://www.nngroup.com/articles/ten-usability-heuristics/
Development: Exploratory Testing
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● 4 sessions
● Charters
● Notes
● Video recordings
● Promissing results
Verification: Use Cases
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● User centered
● Product Life Cycle
● Primary operating functions
● Frequently used functions
● Use cases
- Basic
- Alternatives
- Exceptions
Verification: Preparation
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● Test environment
● Test procedures: level of detail
● Questionnaire (SUMI based)
● User selection
Verification: Execution
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● Introduction
● “User training”
● Test procedures
● Questionnaire (SUMI based)
● Debrief
● Results
● Reporting
Deployment: Validation
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● Subjective vs. Objective
● Expected results & Findings:
− Verification
− User Friendliness
− Learnability
− Error Prevention
● Standards can be helpful,
e.g. treat as heuristics
● Proof required? Practical solutions
● It’s FUN!
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Results & Conclusion
