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| Acknowledgments | |
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| How to Use This Book | |
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| The Limitations of Our Advice | |
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| Who Could Use This Book? | |
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| About the Authors | |
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| Introduction | |
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| What Is Usability Testing? | |
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| What Is a Medical Device? | |
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| General Controls | |
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| Special Controls | |
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| Premarket Approval | |
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| Why Conduct Usability Tests of Medical Devices? | |
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| What Are Common Regulator Comments on Test Plans? | |
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| Is Usability Testing of Medical Devices Required? | |
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| Do You Have to Test Minor Design Changes? | |
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| How Do You Defend Usability Testing Methods to Market Researchers? | |
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| Notes | |
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| Risk Management and Usability Testing | |
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| What Is the Relationship between Usability Testing and Risk Management? | |
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| Can Usability Testing Identify Use-Related Hazards? | |
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| What Is a Dangerous Use Error? | |
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| Is Usability Testing a Reliable Way to Assess the Likelihood That a Dangerous Use Error Will Occur? | |
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| Notes | |
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| The Commercial Imperative | |
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| How Does Testing Affect the Development Schedule? | |
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| Does Usability Testing Offer Liability Protection? | |
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| Can You Develop Marketing Claims Based on Test Results? | |
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| Note | |
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| Testing Costs | |
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| What Should a Request for Quotation for Usability Testing Include? | |
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| What Does a Usability Test Cost? | |
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| What Is the Return on Investment? | |
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| Anatomy of a Usability Test | |
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| What Are the Common Elements of a Usability Test? | |
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| What Is the Proper Duration of a Test Session? | |
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| Do You Have to Be a Usability Specialist to Conduct a Test? | |
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| Does It Take a "Brain Surgeon" to Evaluate Medical Devices? | |
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| Why Test if You Cannot Change the Design? | |
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| How Do You Set Expectations? | |
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| What Can Postpone a Usability Test? | |
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| Note | |
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| Types of Tests | |
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| What Is the Difference between Formative and Summative Usability Testing? | |
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| What Is a Benchmark Usability Test? | |
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| What is an "Out-of-the-Box" Usability Test? | |
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| Can a Test Session Include More Than One Participant? | |
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| Can You Conduct a Group Test? | |
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| How Do You Conduct a "Quick-and-Dirty" Usability Test? | |
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| Notes | |
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| Writing a Test Plan | |
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| What Should a Test Plan Include? | |
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| Does Usability Matter to Regulators? | |
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| Do Usability Test Plans Require Institutional Review Board Approval? | |
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| How Do You Protect Intellectual Property? | |
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| During Test Planning | |
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| During Recruiting | |
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| During the Usability Test | |
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| Notes | |
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| Choosing a Participant Sample and Recruiting Participants | |
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| What Is an Appropriate Sample Size? | |
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| Can Advisory Panel Members Play a Role in Usability Tests? | |
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| Should Children Participate in Usability Tests? | |
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| Should Seniors Participate in Usability Tests? | |
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| How Do You Conduct a Usability Test Involving People with Impairments? | |
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| How Do You Recruit Test Participants? | |
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| Set an Appropriate Compensation Level | |
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| Ensure a Good Cross-Section | |
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| Make the Activity Sound Worthwhile | |
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| Avoid Frauds | |
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| How Do You Recruit Physicians? | |
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| How Do You Recruit Nurses? | |
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| How Do You Prevent No-Shows? | |
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| How Do You Recruit Laypersons? | |
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| Notes | |
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| Test Environments | |
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| What Is the Benefit of Testing in a Medical Environment Simulator? | |
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| How Do You Test in Actual Use Environments? | |
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| Should You Test in a Participant's Workplace? | |
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| Can You Conduct a Usability Test over the Web? | |
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| Can You Test a Device While It Is in Actual Use? | |
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| What if a "Device" Cannot Be Moved? | |
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| Adding Realism | |
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| Why and How Do You Distract Test Participants? | |
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| What Use Is a Mannequin? | |
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| What Role Can a Standardized Patient Play? | |
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| How Do You Simulate Invasive Procedures? | |
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| How Do You Simulate Blood? | |
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| How Do You Simulate Skin and Injections? | |
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| How Do You Simulate Impairments? | |
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| How Do You Simulate Hardware Interactions? | |
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| How Do You Simulate Other Medical Devices? | |
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| Notes | |
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| Selecting Tasks | |
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| Do You Have to Test Everything? | |
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| What Tasks Should Test Participants Perform? | |
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| Why Focus on Potentially Dangerous Tasks? | |
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| How Do You Choose Tasks When Evaluating Use Safety? | |
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| Should Tests Include Maintenance and Service Tasks? | |
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| Can You Test Long-Term Usability? | |
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| How Do You Test Alarms? | |
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| How Do You Test Warning Labels? | |
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| How Do You Test Instructions for Use? | |
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| How Do You Test Symbols? | |
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| How Do You Test Legibility? | |
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| How Do You Evaluate Packaging? | |
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| How Do You Test the Appeal of a Device? | |
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| Notes | |
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| Conducting the Test | |
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| What Is the Value of Pilot Testing? | |
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| Who Should Observe the Test Sessions? | |
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| What Kinds of Usability Problems Arise during a Usability Test? | |
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| What Can Go Wrong before, during, and after a Test? | |
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| What Risk Do Test Personnel Assume? | |
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| Are There Times When the Testing Staff Should Be All Female or All Male? | |
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| Should User Interface Designers Conduct Usability Tests of Their Own Designs? | |
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| When and How Should You Assist Test Participants? | |
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| Can You Modify a Test in Progress? | |
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| Can You Reliably Detect Use Errors? | |
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| Can You Give Test Participants Training? | |
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| Should You Provide Access to Learning Tools? | |
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| Notes | |
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| Interacting with Participants | |
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| When Is It Appropriate to Ask Participants to Think Aloud? | |
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| What Is the Proper Way to Pose a Question? | |
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| Is There a Place for Humor in a Usability Test? | |
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| How Do You Minimize Participant Fatigue? | |
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| How Do You Protect Participants from Harm? | |
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| What If the Test Participant Gets Hurt? | |
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| Notes | |
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| Documenting the Test | |
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| What Data Should You Collect? | |
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| What Use Are Task Times? | |
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| What Is a Good Way to Video Record a Session? | |
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| How Do You Video Record Participants' Interactions with a Moving Device? | |
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| Analyzing Test Data | |
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| What Kind of Statistical Analyses Are Most Useful? | |
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| How Do You Handle Outliers? | |
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| Note | |
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| Reporting Results | |
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| What Makes a Good Test Report? | |
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| Should Test Reports Include Design Recommendations? | |
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| Can Usability Test Results Be Misleading? | |
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| How Do You Deliver Bad News? | |
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| How Do You Explain a Lack of Statistical Significance? | |
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| What Makes a Good Highlight Video? | |
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| Notes | |
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| Validation Testing | |
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| How Does Design Validation Differ from Design Verification | |
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| Design Verification | |
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| Design Validation | |
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| Can a Clinical Trial Supplant Summative Usability Testing? | |
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| Usability Evaluations during Clinical Use | |
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| Can You Conduct a Usability Test in Parallel with a Clinical Trial? | |
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| Can You Conduct a Summative Usability Test without Conducting a Formative Usability Test? | |
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| Notes | |
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| Resources | |
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| Books and Reports | |
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| U.S. Food and Drug Administration (FDA) Publications | |
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| Standards | |
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| Web Sites | |
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| Webinars on CD | |
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| U.S. Courses | |
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| Tools | |
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| Index | |