“Practical usability testing of a molecular diagnostic system” “it’s fun” Romanian Testing Conference 2015! May 2015 Patrick Duisters 1.0 1 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] Improve Quality Services B.V., The Netherlands @PatrickDuisters 2 www.improveqs.nl Experiences & Observation 3 Agenda ● Context ● Usability & Standards ● Usability Program ● Deployment ● Results & Conclusion 4 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 5 Context: 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 6 What is Usability? Usability: characteristic of the USER INTERFACE that establishes EFFECTIVENESS, EFFICIENCY, EASE of USER LEARINING and user SATISFACTION (ISO 62366:2007) Elements of ISO 62366 ●User Friendliness ●Learnability ●Error Prevention ●Iterative Development & Testing 8 Usability Program ● Reviews & Testing Development ● Usability Testing & survey Verification Validation 9 ● Observations & survey Deployment: Development ● Heuristic Analysis ● Exploratory Testing 10 Development: Heuristic Analysis ● Kick-off ● Logging template ● Analysis ● Start early / include! 11 Development: Exploratory Testing ● 4 sessions ● Charters ● Notes ● Video recordings ● Promissing results 12 Verification: Use Cases ● User centered ● Product Life Cycle ● Primary operating functions ● Frequently used functions ● Use cases - Basic - Alternatives - Exceptions 14 Verification: Preparation ● Test environment ● Test procedures: level of detail ● Questionnaire (SUMI based) ● User selection 15 Verification: Execution ● Introduction ● “User training” ● Test procedures ● Questionnaire (SUMI based) ● Debrief ● Results ● Reporting 16 Deployment: Validation 1 17 Results & Conclusion ● 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! 18 Questions [email protected] 19
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