1 “Practical usability testing of a molecular diagnostic system” “it’s fun” Romanian Testing Conference 2015! May 2015 Patrick Duisters 1.0

1

“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

mailto:[email protected]

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAQQjRw&url=http://openateliersdenhaag.nl/&ei=7sAjVOHeI4rMyAPBuoKYDw&bvm=bv.76247554,d.bGQ&psig=AFQjCNGZQPNkn22vVIza1Z9rrj-eIW_V4w&ust=1411715694618763

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Experiences & Observation

http://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&docid=x0_pg5IUuzAG6M&tbnid=W2n_vyxDoAgpnM:&ved=0CAUQjRw&url=http://gathering.tweakers.net/forum/list_messages/1522756/11&ei=j1I-U9_cBcSI0AW4_YCQDA&bvm=bv.64125504,d.d2k&psig=AFQjCNGQyR7pqCru74pX1NtoWHMg1-e9Fg&ust=1396679667934477

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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

http://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=6LtevCKDv4wqCM&tbnid=mrriFACx5vSf6M:&ved=0CAUQjRw&url=http://ideas4pm.wordpress.com/tag/error-prevention/&ei=MC7iU5-dKojdObfZgaAC&bvm=bv.72197243,d.ZWU&psig=AFQjCNFW6x6JAuhVnsira_2v5tjiZOwZjQ&ust=1407417774892055

Usability Program

● Reviews & Testing

● Usability Testing & survey

● Observations & survey

9

Development

Verification

Validation

Deployment: Development

10

● Heuristic Analysis● Exploratory Testing

Development: Heuristic Analysis

11

● Kick-off● Logging template● Analysis

● Start early / include!

http://www.nngroup.com/articles/ten-usability-heuristics/

Development: Exploratory Testing

12

● 4 sessions● Charters● Notes● Video recordings

● Promissing results

Verification: Use Cases

14

● User centered

● Product Life Cycle

● Primary operating functions● Frequently used functions

● Use cases- Basic- Alternatives- Exceptions

Verification: Preparation

15

● Test environment● Test procedures: level of detail● Questionnaire (SUMI based)● User selection

Verification: Execution

16

SUMI based

● Introduction● “User training”● Test procedures● Questionnaire (SUMI based)● Debrief● Results● Reporting

Deployment: Validation

17

1

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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!

18

Results & Conclusion

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Questions

[email protected]

mailto:[email protected]

Documents

1 “Practical usability testing of a molecular diagnostic system” “it’s fun” Romanian Testing Conference 2015! May 2015 Patrick Duisters 1.0