Acknowledgments |
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xi | |
About the Authors |
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xiii | |
How to use this book |
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xvii | |
The limitations of our advice |
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xix | |
Who could use this book? |
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xxi | |
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1 | (36) |
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What is usability testing? |
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2 | (4) |
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What is a medical device? |
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6 | (4) |
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Why conduct usability tests of medical devices? |
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10 | (2) |
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12 | (4) |
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16 | (3) |
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19 | (2) |
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What are common regulator comments on summative (i.e., validation) test plans? |
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21 | (5) |
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Is usability testing of medical devices required? |
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26 | (4) |
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Do you have to test minor design changes? |
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30 | (2) |
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How do you defend usability testing methods to market researchers? |
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32 | (2) |
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34 | (3) |
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Chapter 2 Risk management and usability testing |
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37 | (16) |
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What is the relationship between usability testing and risk management? |
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38 | (1) |
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Can usability testing identify use-related hazards? |
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39 | (1) |
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What is a dangerous use error? |
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40 | (6) |
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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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46 | (2) |
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Do you have to evaluate every risk mitigation? |
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48 | (3) |
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51 | (2) |
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Chapter 3 The commercial imperative |
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53 | (10) |
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How does testing affect the development schedule? |
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54 | (2) |
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Does usability testing offer liability protection? |
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56 | (3) |
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Can you develop marketing claims based on test results? |
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59 | (3) |
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62 | (1) |
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63 | (16) |
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What should a request for quotation for usability testing include? |
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64 | (4) |
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What does a usability test cost? |
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68 | (7) |
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What is the return on investment? |
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75 | (4) |
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Chapter 5 Anatomy of a usability test |
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79 | (32) |
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What are the common elements of a usability test? |
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80 | (6) |
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What is the proper duration of a test session? |
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86 | (4) |
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Do you have to be a usability specialist to conduct a test? |
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90 | (2) |
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Does it take a "brain surgeon" to evaluate medical devices? |
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92 | (4) |
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Why test if you cannot change the design? |
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96 | (1) |
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How do you set expectations? |
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97 | (3) |
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What can postpone a usability test? |
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100 | (6) |
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What ethical dilemmas might arise? |
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106 | (4) |
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110 | (1) |
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111 | (24) |
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What is the difference between formative and summative usability testing? |
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112 | (5) |
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What is a benchmark usability test? |
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117 | (4) |
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What is an "out-of-the-box" usability test? |
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121 | (2) |
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Can a test session include more than one participant? |
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123 | (3) |
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Can you conduct a group test? |
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126 | (3) |
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How do you conduct a "quick-and-dirty" usability test? |
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129 | (2) |
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Are there special considerations when testing a "legacy" device? |
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131 | (3) |
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134 | (1) |
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Chapter 7 Writing a test plan |
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135 | (20) |
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What should a test plan include? |
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136 | (2) |
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Does usability matter to regulators? |
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138 | (5) |
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Do usability test plans require IRB approval? |
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143 | (4) |
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How do you protect intellectual property? |
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147 | (3) |
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Must a regulator approve a summative usability test plan? |
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150 | (2) |
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152 | (3) |
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Chapter 8 Choosing a participant sample and recruiting participants |
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155 | (34) |
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What is an appropriate sample size? |
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156 | (3) |
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Can advisory panel members play a role in usability tests? |
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159 | (2) |
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Should children participate in usability tests? |
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161 | (3) |
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Should seniors participate in usability tests? |
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164 | (3) |
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How do you test a device used jointly by a child and parent? |
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167 | (2) |
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How do you conduct a usability test involving people with impairments? |
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169 | (6) |
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How do you recruit test participants? |
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175 | (5) |
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How do you recruit physicians? |
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180 | (1) |
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How do you recruit nurses? |
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181 | (2) |
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How do you recruit laypersons? |
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183 | (3) |
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How do you prevent no-shows? |
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186 | (2) |
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188 | (1) |
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Chapter 9 Test environments |
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189 | (40) |
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What does building a usability test laboratory entail? |
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190 | (9) |
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What is the benefit of testing in a medical simulation facility? |
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199 | (3) |
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How do you test in actual use environments? |
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202 | (5) |
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How does testing a home health care device differ from testing a device used in clinical settings? |
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207 | (5) |
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Should you test in a participant's workplace? |
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212 | (3) |
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Can you conduct a usability test over the Web? |
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215 | (5) |
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Can you test a device while it is in actual use? |
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220 | (1) |
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How do you conduct a nocturnal test? |
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221 | (4) |
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What if a device cannot be moved? |
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225 | (3) |
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228 | (1) |
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Chapter 10 Adding realism |
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229 | (32) |
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Why and how do you distract test participants? |
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230 | (3) |
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233 | (4) |
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What role can a standardized patient play? |
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237 | (3) |
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How do you simulate surgical procedures? |
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240 | (5) |
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How do you simulate blood? |
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245 | (3) |
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How do you simulate skin and injections? |
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248 | (2) |
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How do you simulate impairments? |
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250 | (5) |
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How do you simulate hardware interactions? |
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255 | (2) |
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How do you simulate other medical devices? |
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257 | (3) |
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260 | (1) |
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Chapter 11 Selecting tasks |
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261 | (56) |
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Do you have to test everything? |
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262 | (2) |
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What tasks should test participants perform? |
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264 | (3) |
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How do-you make tasks flow naturally? |
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267 | (3) |
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Why focus on potentially dangerous tasks? |
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270 | (2) |
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How do you choose tasks when evaluating use-safety? |
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272 | (2) |
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What if there are no high risks? |
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274 | (2) |
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How do you assess risk control measures associated with very unlikely use errors? |
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276 | (2) |
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How do you assess effectiveness? |
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278 | (3) |
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Should tests include maintenance and service tasks? |
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281 | (2) |
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Can you test long-term usability? |
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283 | (2) |
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285 | (2) |
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How do you test warning labels? |
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287 | (3) |
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How do you test instructions for use? |
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290 | (3) |
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293 | (3) |
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How do you test legibility? |
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296 | (5) |
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How do you evaluate packaging? |
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301 | (3) |
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How do you test the appeal of a device? |
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304 | (3) |
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How do you prioritize tasks? |
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307 | (4) |
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Is there value in directing participants to repeat tasks? |
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311 | (4) |
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315 | (2) |
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Chapter 12 Conducting the test |
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317 | (40) |
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What is the value of pilot testing? |
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318 | (2) |
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Who should observe the test sessions? |
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320 | (3) |
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What kinds of usability problems arise during a usability test? |
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323 | (6) |
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What can go wrong before, during, and after a test? |
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329 | (3) |
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What risks do test personnel assume? |
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332 | (3) |
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Are there times when the testing staff should be all female or all male? |
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335 | (2) |
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Should user interface designers conduct usability tests of their own designs? |
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337 | (2) |
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When and how should you assist test participants? |
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339 | (4) |
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Can you modify a test in progress? |
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343 | (3) |
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Can you reliably detect use errors? |
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346 | (2) |
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Can you deliver training to test participants? |
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348 | (4) |
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Should you provide access to learning tools? |
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352 | (4) |
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356 | (1) |
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Chapter 13 Interacting with participants |
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357 | (18) |
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When is it appropriate to ask participants to think aloud? |
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358 | (3) |
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What is the proper way to pose a question? |
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361 | (2) |
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Is there a place for humor in a usability test? |
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363 | (2) |
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How do you minimize participant fatigue? |
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365 | (2) |
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How do you protect participants from harm? |
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367 | (3) |
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What if the test participant gets hurt? |
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370 | (3) |
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373 | (2) |
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Chapter 14 Documenting the test |
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375 | (14) |
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What data should you collect? |
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376 | (4) |
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380 | (3) |
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What is a good way to video record a session? |
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383 | (3) |
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How do you video record participants' interactions with a moving device? |
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386 | (3) |
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Chapter 15 Analyzing test data |
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389 | (16) |
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What kind of statistical analyses are most useful? |
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390 | (5) |
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How do you handle outliers? |
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395 | (3) |
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What role does root cause analysis play? |
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398 | (5) |
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403 | (2) |
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Chapter 16 Reporting results |
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405 | (20) |
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What makes a good test report? |
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406 | (5) |
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Should test reports include design recommendations? |
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411 | (3) |
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Can usability test results be misleading? |
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414 | (2) |
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How do you deliver bad news? |
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416 | (3) |
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How do you explain a lack of statistical significance? |
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419 | (1) |
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What makes a good highlight video? |
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420 | (4) |
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424 | (1) |
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Chapter 17 Validation testing |
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425 | (14) |
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How does design validation differ from design verification? |
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426 | (1) |
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Do you need to conduct a test prior to filing for an investigational device exemption? |
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427 | (2) |
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Can a clinical trial supplant summative usability testing? |
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429 | (5) |
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Can you conduct a usability test in parallel with a clinical trial? |
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434 | (2) |
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Can you conduct a summative usability test without conducting a formative usability test? |
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436 | (2) |
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438 | (1) |
Resources |
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439 | (8) |
Index |
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447 | |