Usability Testing of Medical Devices 1st Edition by Michael E Wiklund, Jonathan Kendler, Allison Y Strochlic ISBN 1439811830 9781439811832

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Product details:

ISBN 10: 1439811830 
ISBN 13: 9781439811832
Author: Michael E Wiklund, Jonathan Kendler, Allison Y Strochlic

Usability Testing of Medical Devices 1st Table of contents:

Chapter 1: Introduction

• What is usability testing?

• What is a medical device?

• Class I: General controls

• Class II: Special controls

• Class III: Premarket approval

• Why conduct usability tests of medical devices?

• What is a use error?

• What is a close call?

• What is a difficulty?

• Common regulator comments on summative (validation) test plans

• Is usability testing of medical devices required?

• Do you have to test minor design changes?

• How do you defend usability testing methods to market researchers?

• References

Chapter 2: Risk Management and Usability Testing

• Relationship between usability testing and risk management

• Can usability testing identify use-related hazards?

• What is a dangerous use error?

• Is usability testing reliable to assess likelihood of dangerous use errors?

• Do you have to evaluate every risk mitigation?

• References

Chapter 3: The Commercial Imperative

• How testing affects development schedule

• Does usability testing offer liability protection?

• Can marketing claims be developed based on test results?

• Reference

Chapter 4: Testing Costs

• What should a request for quotation include?

• What does a usability test cost?

• Return on investment

Chapter 5: Anatomy of a Usability Test

• Common elements of a usability test

• Proper duration of a test session

• Do you need to be a usability specialist to conduct a test?

• Evaluating medical devices – expert requirements

• Why test if you cannot change the design?

• How to set expectations

• What can postpone a usability test?

• Ethical dilemmas in usability testing

• Reference

Chapter 6: Types of Tests

• Difference between formative and summative usability testing

• Benchmark usability test

• “Out-of-the-box” usability test

• Multiple participants in a test session

• Conducting group tests

• “Quick-and-dirty” usability tests

• Special considerations for “legacy” devices

• References

Chapter 7: Writing a Test Plan

• What a test plan should include

• Importance of usability to regulators

• Is usability testing required for CE mark?

• Usability goals and testing

• IRB approval for usability test plans

• Protecting intellectual property during planning, recruiting, and testing

• Must regulators approve summative test plans?

• References

Chapter 8: Choosing and Recruiting Participants

• Appropriate sample size

• Role of advisory panel members

• Including children in tests

• Including seniors in tests

• Testing devices used jointly by child and parent

• Testing with people with impairments

• Recruitment strategies and considerations: compensation, diversity, fraud prevention

• Recruiting physicians, nurses, laypersons

• Preventing no-shows

• References

Chapter 9: Test Environments

• Building a usability test lab: test room, observation room, one-way mirror, soundproofing, video, audio, ventilation

• Equipment for clinical environment simulation

• Client lounge and miscellaneous features

• Laboratory photos and floor plan

• Benefits of medical simulation facilities

• Testing in actual use environments: home healthcare, clinical settings, controlled settings

• Testing in participant’s workplace

• Usability testing over the web

• Testing devices in actual use

• Conducting nocturnal tests

• Testing immovable devices

• Reference

Chapter 10: Adding Realism

• Distracting test participants

• Use of mannequins and standardized patients

• Simulating surgical procedures, blood, skin, injections

• Simulating impairments

• Simulating hardware and other medical devices

• References

Chapter 11: Selecting Tasks

• Must everything be tested?

• Choosing tasks for test participants

• Making tasks flow naturally

• Focus on potentially dangerous tasks

• Evaluating use-safety

• Assessing risk control for unlikely use errors

• Effectiveness assessment

• Including maintenance and service tasks

• Testing long-term usability

• Testing alarms, warning labels, instructions for use, symbols, legibility, packaging, appeal

• Prioritizing tasks: riskiness, documentation, pre-mitigation risks

• Repeating tasks for assessment

• Assessing task speed and use errors

• Root cause analysis

• Validating instructions for use (IFU)

• Counterarguments and conclusion

• References

Chapter 12: Conducting the Test

• Value of pilot testing

• Who should observe sessions?

• Common usability problems during tests

• Possible issues before, during, and after testing

• Risks to test personnel

• Gender considerations in testing staff

• Should UI designers test their own designs?

• When and how to assist participants

• Modifying tests in progress

• Detecting use errors reliably

• Training and learning tools for participants

• References

Chapter 13: Interacting with Participants

• When to ask participants to think aloud

• Proper questioning techniques

• Role of humor

• Minimizing participant fatigue

• Protecting participants from harm

• Handling participant injury

• References

Chapter 14: Documenting the Test

• Data to collect

• Use of task times

• Video recording techniques for sessions and moving devices

Chapter 15: Analyzing Test Data

• Useful statistical analyses (with case studies)

• Handling outliers

• Role of root cause analysis

• Avoid blaming users

• References

Chapter 16: Reporting Results

• Characteristics of a good test report

• Including design recommendations

• Avoiding misleading test results

• Delivering bad news (with examples)

• Explaining lack of statistical significance

• Creating highlight videos

• References

Chapter 17: Validation Testing

• Design validation vs. design verification

• Testing prior to investigational device exemption filing

• Clinical trials vs. summative usability testing

• Usability evaluations during clinical use

• Parallel testing with clinical trials

• Summative testing without formative testing

• References

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Tags: Michael E Wiklund, Jonathan Kendler, Allison Y Strochlic, Usability Testing