Acknowledgments |
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xi | |
How to Use This Book |
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xiii | |
The Limitations of Our Advice |
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xv | |
Who Could Use This Book? |
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xvii | |
About the Authors |
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xix | |
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1 | (24) |
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What is Usability Testing? |
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2 | (5) |
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What is a Medical Device? |
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7 | (3) |
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8 | (1) |
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Class II Special Controls |
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9 | (1) |
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Class III Premarket Approval |
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9 | (1) |
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Why Conduct Usability Tests of Medical Devices? |
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10 | (2) |
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What are Common Regulator Comments on Test Plans? |
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12 | (4) |
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Is Usability Testing of Medical Devices Required? |
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16 | (3) |
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Do You Have to Test Minor Design Changes? |
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19 | (2) |
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How Do You Defend Usability Testing Methods to Market Researchers? |
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21 | (1) |
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22 | (3) |
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Chapter 2 Risk Management and Usability Testing |
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25 | (14) |
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What is the Relationship between Usability Testing and Risk Management? |
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26 | (2) |
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Can Usability Testing Identify Use-Related Hazards? |
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28 | (2) |
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What is a Dangerous Use Error? |
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30 | (5) |
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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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35 | (1) |
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36 | (3) |
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Chapter 3 The Commercial Imperative |
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39 | (10) |
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How Does Testing Affect the Development Schedule? |
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40 | (3) |
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Does Usability Testing Offer Liability Protection? |
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43 | (3) |
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Can You Develop Marketing Claims Based on Test Results? |
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46 | (2) |
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48 | (1) |
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49 | (14) |
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What Should a Request for Quotation for Usability Testing Include? |
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50 | (4) |
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What Does a Usability Test Cost? |
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54 | (6) |
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What is the Return on Investment? |
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60 | (3) |
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Chapter 5 Anatomy of a Usability Test |
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63 | (26) |
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What are the Common Elements of a Usability Test? |
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64 | (6) |
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What is the Proper Duration of a Test Session? |
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70 | (3) |
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Do You Have to be a Usability Specialist to Conduct a Test? |
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73 | (2) |
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Does it Take a "Brain Surgeon" to Evaluate Medical Devices? |
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75 | (4) |
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Why Test if You Cannot Change the Design? |
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79 | (2) |
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How Do You Set Expectations? |
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81 | (3) |
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What Can Postpone a Usability Test? |
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84 | (4) |
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88 | (1) |
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89 | (18) |
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What is the Difference between Formative and Summative Usability Testing? |
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90 | (3) |
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What is a Benchmark Usability Test? |
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93 | (3) |
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What is an "Out-of-the-Box" Usability Test? |
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96 | (2) |
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Can a Test Session Include More Than One Participant? |
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98 | (3) |
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Can You Conduct a Group Test? |
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101 | (3) |
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How Do You Conduct a "Quick-and-Dirty" Usability Test? |
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104 | (1) |
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105 | (2) |
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Chapter 7 Writing a Test Plan |
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107 | (14) |
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What Should a Test Plan Include? |
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108 | (2) |
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Does Usability Matter to Regulators? |
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110 | (4) |
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Do Usability Test Plans Require Institutional Review Board Approval? |
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114 | (4) |
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How Do You Protect Intellectual Property? |
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118 | (1) |
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118 | (1) |
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118 | (1) |
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During the Usability Test |
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118 | (1) |
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119 | (2) |
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Chapter 8 Choosing a Participant Sample and Recruiting Participants |
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121 | (30) |
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What is an Appropriate Sample Size? |
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122 | (2) |
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Can Advisory Panel Members Play a Role in Usability Tests? |
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124 | (2) |
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Should Children Participate in Usability Tests? |
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126 | (3) |
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Should Seniors Participate in Usability Tests? |
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129 | (3) |
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How Do You Conduct a Usability Test Involving People with Impairments? |
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132 | (5) |
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How Do You Recruit Test Participants? |
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137 | (1) |
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Set an Appropriate Compensation Level |
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137 | (1) |
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Ensure a Good Cross-Section |
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138 | (1) |
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Make the Activity Sound Worthwhile |
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139 | (1) |
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139 | (2) |
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How Do You Recruit Physicians? |
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141 | (2) |
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How Do You Recruit Nurses? |
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143 | (2) |
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How Do You Prevent No-Shows? |
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145 | (2) |
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How Do You Recruit Laypersons? |
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147 | (2) |
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149 | (2) |
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Chapter 9 Test Environments |
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151 | (22) |
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What is the Benefit of Testing in a Medical Environment Simulator? |
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152 | (4) |
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How Do You Test in Actual Use Environments? |
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156 | (4) |
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Should You Test in a Participant's Workplace? |
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160 | (4) |
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Can You Conduct a Usability Test over the Web? |
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164 | (4) |
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Can You Test a Device While it is in Actual Use? |
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168 | (2) |
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What if a "Device" Cannot Be Moved? |
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170 | (3) |
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Chapter 10 Adding Realism |
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173 | (30) |
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Why and How Do You Distract Test Participants? |
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174 | (3) |
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177 | (4) |
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What Role Can a Standardized Patient Play? |
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181 | (2) |
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How Do You Simulate Invasive Procedures? |
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183 | (3) |
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How Do You Simulate Blood? |
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186 | (3) |
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How Do You Simulate Skin and Injections? |
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189 | (3) |
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How Do You Simulate Impairments? |
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192 | (5) |
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How Do You Simulate Hardware Interactions? |
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197 | (2) |
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How Do You Simulate Other Medical Devices? |
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199 | (2) |
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201 | (2) |
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Chapter 11 Selecting Tasks |
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203 | (40) |
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Do You Have to Test Everything? |
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204 | (2) |
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What Tasks Should Test Participants Perform? |
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206 | (3) |
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Why Focus on Potentially Dangerous Tasks? |
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209 | (2) |
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How Do You Choose Tasks When Evaluating Use Safety? |
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211 | (2) |
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Should Tests Include Maintenance and Service Tasks? |
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213 | (2) |
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Can You Test Long-Term Usability? |
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215 | (3) |
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218 | (2) |
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How Do You Test Warning Labels? |
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220 | (3) |
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How Do You Test Instructions for Use? |
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223 | (3) |
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226 | (3) |
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How Do You Test Legibility? |
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229 | (6) |
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How Do You Evaluate Packaging? |
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235 | (3) |
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How Do You Test the Appeal of a Device? |
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238 | (2) |
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240 | (3) |
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Chapter 12 Conducting the Test |
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243 | (40) |
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What is the Value of Pilot Testing? |
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244 | (2) |
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Who Should Observe the Test Sessions? |
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246 | (4) |
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What Kinds of Usability Problems Arise during a Usability Test? |
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250 | (6) |
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What Can Go Wrong before, during, and after a Test? |
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256 | (3) |
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What Risk Do Test Personnel Assume? |
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259 | (3) |
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Are There Times When the Testing Staff Should Be All Female or all Male? |
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262 | (2) |
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Should User Interface Designers Conduct Usability Tests of Their Own Designs? |
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264 | (2) |
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When and How Should You Assist Test Participants? |
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266 | (3) |
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Can You Modify a Test in Progress? |
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269 | (3) |
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Can You Reliably Detect Use Errors? |
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272 | (2) |
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Can You Give Test Participants Training? |
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274 | (4) |
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Should You Provide Access to Learning Tools? |
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278 | (3) |
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281 | (2) |
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Chapter 13 Interacting with Participants |
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283 | (16) |
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When is it Appropriate to Ask Participants to Think Aloud? |
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284 | (3) |
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What is the Proper Way to Pose a Question? |
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287 | (2) |
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Is There a Place for Humor in a Usability Test? |
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289 | (2) |
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How Do You Minimize Participant Fatigue? |
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291 | (2) |
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How Do You Protect Participants from Harm? |
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293 | (3) |
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What if the Test Participant Gets Hurt? |
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296 | (2) |
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298 | (1) |
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Chapter 14 Documenting the Test |
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299 | (12) |
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What Data Should You Collect? |
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300 | (4) |
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304 | (2) |
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What is a Good Way to Video Record a Session? |
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306 | (3) |
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How Do You Video Record Participants' Interactions with a Moving Device? |
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309 | (2) |
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Chapter 15 Analyzing Test Data |
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311 | (10) |
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What Kind of Statistical Analyses are Most Useful? |
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312 | (5) |
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312 | (1) |
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312 | (1) |
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312 | (1) |
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313 | (1) |
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313 | (4) |
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How Do You Handle Outliers? |
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317 | (2) |
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319 | (2) |
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Chapter 16 Reporting Results |
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321 | (18) |
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What Makes a Good Test Report? |
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322 | (4) |
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Should Test Reports Include Design Recommendations? |
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326 | (3) |
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Can Usability Test Results Be Misleading? |
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329 | (3) |
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How Do You Deliver Bad News? |
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332 | (1) |
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333 | (1) |
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333 | (1) |
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How Do You Explain a Lack of Statistical Significance? |
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334 | (2) |
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What Makes a Good Highlight Video? |
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336 | (2) |
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338 | (1) |
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Chapter 17 Validation Testing |
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339 | (12) |
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How Does Design Validation Differ from Design Verification? |
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340 | (1) |
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340 | (1) |
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340 | (2) |
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Can a Clinical Trial Supplant Summative Usability Testing? |
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342 | (2) |
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Usability Evaluations during Clinical Use |
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344 | (2) |
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Can You Conduct a Usability Test in Parallel with a Clinical Trial? |
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346 | (2) |
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Can You Conduct a Summative Usability Test without Conducting a Formative Usability Test? |
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348 | (1) |
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349 | (2) |
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351 | (4) |
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352 | (1) |
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U.S. Food and Drug Administration (FDA) Publications |
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352 | (1) |
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353 | (1) |
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353 | (1) |
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353 | (1) |
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354 | (1) |
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354 | (1) |
Index |
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355 | |