Title:
Usability testing of medical devices
Personal Author:
Publication Information:
Boca Raton : Taylor & Francis, 2011
Physical Description:
xxi, 374 p. : ill. ; 24 cm.
ISBN:
9781439811832
Abstract:
"Informative, practical, and engaging, this handbook covers how to conduct usability tests of medical devices. Recognizing that the intended readers, including marketers, engineers, and regulatory affairs specialists, are busy and disinclined to read lengthy textbooks, this book has been carefully designed to be concise and visual, allowing readers to read it all in one sitting or jump from one section to another as needed. The book provides a general understanding of usability testing and reviews key concepts. It highlights the challenges of validating that protects against dangerous errors that could lead to patient injury and death"--Provided by publisher.
Subject Term:
Available:*
Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
|---|---|---|---|---|---|
Searching... | 30000010274510 | R856.4 W55 2011 | Open Access Book | Book | Searching... |
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Summary
Summary
To paraphrase a popular saying, usability testing should be done early and often. However, it doesn't have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devicesprovides a simple, easy to implement general understanding of usability testing. It offers a general understanding of usability testing and reviews key concepts, highlighting the challenges of validating that protects against dangerous errors that could lead to patient injury and death.
The book has been carefully designed to be concise and visually, easily read in one sitting or perused from one section to another as needed It begins with a review of human factors engineering and how usability testing fits in, and then discusses the government regulations and industry standards that have motivated many medical device manufacturers to conduct usability tests. It then covers the nitty-gritty of planning, conducting, and reporting the results of a usability test, making the process as smooth and painless as possible for the development team, and therefore making the medical devices they develop as safe, effective, and appealing as possible.
As you read the book, keep in mind that, like snowflakes, each usability test is unique. And while 100 usability specialists working independently might take 100 different approaches to testing, albeit with considerable methodological overlap, there would also be meaningful differences that the practitioners would energetically defend as the best given the circumstances. To make your testing process easier, the authors, seasoned human factors specialists who have conducted thousands of test sessions involving medical devices used by physicians, nurses, therapists, technicians, and patients, have painstakingly put together an informative, practical, and engaging handbook for conducting usability tests of medical devices.
Table of Contents
| Acknowledgments | p. xi |
| How to Use This Book | p. xiii |
| The Limitations of Our Advice | p. xv |
| Who Could Use This Book? | p. xvii |
| About the Authors | p. xix |
| Chapter 1 Introduction | p. 1 |
| What Is Usability Testing? | p. 2 |
| What Is a Medical Device? | p. 7 |
| Class I General Controls | p. 8 |
| Class II Special Controls | p. 9 |
| Class III Premarket Approval | p. 9 |
| Why Conduct Usability Tests of Medical Devices? | p. 10 |
| What Are Common Regulator Comments on Test Plans? | p. 12 |
| Is Usability Testing of Medical Devices Required? | p. 16 |
| Do You Have to Test Minor Design Changes? | p. 19 |
| How Do You Defend Usability Testing Methods to Market Researchers? | p. 21 |
| Notes | p. 22 |
| Chapter 2 Risk Management and Usability Testing | p. 25 |
| What Is the Relationship between Usability Testing and Risk Management? | p. 26 |
| Can Usability Testing Identify Use-Related Hazards? | p. 28 |
| What Is a Dangerous Use Error? | p. 30 |
| Is Usability Testing a Reliable Way to Assess the Likelihood That a Dangerous Use Error Will Occur? | p. 35 |
| Notes | p. 36 |
| Chapter 3 The Commercial Imperative | p. 39 |
| How Does Testing Affect the Development Schedule? | p. 40 |
| Does Usability Testing Offer Liability Protection? | p. 43 |
| Can You Develop Marketing Claims Based on Test Results? | p. 46 |
| Note | p. 48 |
| Chapter 4 Testing Costs | p. 49 |
| What Should a Request for Quotation for Usability Testing Include? | p. 50 |
| What Does a Usability Test Cost? | p. 54 |
| What Is the Return on Investment? | p. 60 |
| Chapter 5 Anatomy of a Usability Test | p. 63 |
| What Are the Common Elements of a Usability Test? | p. 64 |
| What Is the Proper Duration of a Test Session? | p. 70 |
| Do You Have to Be a Usability Specialist to Conduct a Test? | p. 73 |
| Does It Take a "Brain Surgeon" to Evaluate Medical Devices? | p. 75 |
| Why Test if You Cannot Change the Design? | p. 79 |
| How Do You Set Expectations? | p. 81 |
| What Can Postpone a Usability Test? | p. 84 |
| Note | p. 88 |
| Chapter 6 Types of Tests | p. 89 |
| What Is the Difference between Formative and Summative Usability Testing? | p. 90 |
| What Is a Benchmark Usability Test? | p. 93 |
| What is an "Out-of-the-Box" Usability Test? | p. 96 |
| Can a Test Session Include More Than One Participant? | p. 98 |
| Can You Conduct a Group Test? | p. 101 |
| How Do You Conduct a "Quick-and-Dirty" Usability Test? | p. 104 |
| Notes | p. 105 |
| Chapter 7 Writing a Test Plan | p. 107 |
| What Should a Test Plan Include? | p. 108 |
| Does Usability Matter to Regulators? | p. 110 |
| Do Usability Test Plans Require Institutional Review Board Approval? | p. 114 |
| How Do You Protect Intellectual Property? | p. 118 |
| During Test Planning | p. 118 |
| During Recruiting | p. 118 |
| During the Usability Test | p. 118 |
| Notes | p. 119 |
| Chapter 8 Choosing a Participant Sample and Recruiting Participants | p. 121 |
| What Is an Appropriate Sample Size? | p. 122 |
| Can Advisory Panel Members Play a Role in Usability Tests? | p. 124 |
| Should Children Participate in Usability Tests? | p. 126 |
| Should Seniors Participate in Usability Tests? | p. 129 |
| How Do You Conduct a Usability Test Involving People with Impairments? | p. 132 |
| How Do You Recruit Test Participants? | p. 137 |
| Set an Appropriate Compensation Level | p. 137 |
| Ensure a Good Cross-Section | p. 138 |
| Make the Activity Sound Worthwhile | p. 139 |
| Avoid Frauds | p. 139 |
| How Do You Recruit Physicians? | p. 141 |
| How Do You Recruit Nurses? | p. 143 |
| How Do You Prevent No-Shows? | p. 145 |
| How Do You Recruit Laypersons? | p. 147 |
| Notes | p. 149 |
| Chapter 9 Test Environments | p. 151 |
| What Is the Benefit of Testing in a Medical Environment Simulator? | p. 152 |
| How Do You Test in Actual Use Environments? | p. 156 |
| Should You Test in a Participant's Workplace? | p. 160 |
| Can You Conduct a Usability Test over the Web? | p. 164 |
| Can You Test a Device While It Is in Actual Use? | p. 168 |
| What if a "Device" Cannot Be Moved? | p. 170 |
| Chapter 10 Adding Realism | p. 173 |
| Why and How Do You Distract Test Participants? | p. 174 |
| What Use Is a Mannequin? | p. 177 |
| What Role Can a Standardized Patient Play? | p. 181 |
| How Do You Simulate Invasive Procedures? | p. 183 |
| How Do You Simulate Blood? | p. 186 |
| How Do You Simulate Skin and Injections? | p. 189 |
| How Do You Simulate Impairments? | p. 192 |
| How Do You Simulate Hardware Interactions? | p. 197 |
| How Do You Simulate Other Medical Devices? | p. 199 |
| Notes | p. 201 |
| Chapter 11 Selecting Tasks | p. 203 |
| Do You Have to Test Everything? | p. 204 |
| What Tasks Should Test Participants Perform? | p. 206 |
| Why Focus on Potentially Dangerous Tasks? | p. 209 |
| How Do You Choose Tasks When Evaluating Use Safety? | p. 211 |
| Should Tests Include Maintenance and Service Tasks? | p. 213 |
| Can You Test Long-Term Usability? | p. 215 |
| How Do You Test Alarms? | p. 218 |
| How Do You Test Warning Labels? | p. 220 |
| How Do You Test Instructions for Use? | p. 223 |
| How Do You Test Symbols? | p. 226 |
| How Do You Test Legibility? | p. 229 |
| How Do You Evaluate Packaging? | p. 235 |
| How Do You Test the Appeal of a Device? | p. 238 |
| Notes | p. 240 |
| Chapter 12 Conducting the Test | p. 243 |
| What Is the Value of Pilot Testing? | p. 244 |
| Who Should Observe the Test Sessions? | p. 246 |
| What Kinds of Usability Problems Arise during a Usability Test? | p. 250 |
| What Can Go Wrong before, during, and after a Test? | p. 256 |
| What Risk Do Test Personnel Assume? | p. 259 |
| Are There Times When the Testing Staff Should Be All Female or All Male? | p. 262 |
| Should User Interface Designers Conduct Usability Tests of Their Own Designs? | p. 264 |
| When and How Should You Assist Test Participants? | p. 266 |
| Can You Modify a Test in Progress? | p. 269 |
| Can You Reliably Detect Use Errors? | p. 272 |
| Can You Give Test Participants Training? | p. 274 |
| Should You Provide Access to Learning Tools? | p. 278 |
| Notes | p. 281 |
| Chapter 13 Interacting with Participants | p. 283 |
| When Is It Appropriate to Ask Participants to Think Aloud? | p. 284 |
| What Is the Proper Way to Pose a Question? | p. 287 |
| Is There a Place for Humor in a Usability Test? | p. 289 |
| How Do You Minimize Participant Fatigue? | p. 291 |
| How Do You Protect Participants from Harm? | p. 293 |
| What If the Test Participant Gets Hurt? | p. 296 |
| Notes | p. 298 |
| Chapter 14 Documenting the Test | p. 299 |
| What Data Should You Collect? | p. 300 |
| What Use Are Task Times? | p. 304 |
| What Is a Good Way to Video Record a Session? | p. 306 |
| How Do You Video Record Participants' Interactions with a Moving Device? | p. 309 |
| Chapter 15 Analyzing Test Data | p. 311 |
| What Kind of Statistical Analyses Are Most Useful? | p. 312 |
| Case 1 p. 312 | |
| Case 2 p. 312 | |
| Case 3 p. 312 | |
| Case 4 p. 313 | |
| Case 5 p. 313 | |
| How Do You Handle Outliers? | p. 317 |
| Note | p. 319 |
| Chapter 16 Reporting Results | p. 321 |
| What Makes a Good Test Report? | p. 322 |
| Should Test Reports Include Design Recommendations? | p. 326 |
| Can Usability Test Results Be Misleading? | p. 329 |
| How Do You Deliver Bad News? | p. 332 |
| Example 1 p. 333 | |
| Example 2 p. 333 | |
| How Do You Explain a Lack of Statistical Significance? | p. 334 |
| What Makes a Good Highlight Video? | p. 336 |
| Notes | p. 338 |
| Chapter 17 Validation Testing | p. 339 |
| How Does Design Validation Differ from Design Verification | p. 340 |
| Design Verification | p. 340 |
| Design Validation | p. 340 |
| Can a Clinical Trial Supplant Summative Usability Testing? | p. 342 |
| Usability Evaluations during Clinical Use | p. 344 |
| Can You Conduct a Usability Test in Parallel with a Clinical Trial? | p. 346 |
| Can You Conduct a Summative Usability Test without Conducting a Formative Usability Test? | p. 348 |
| Notes | p. 349 |
| Resources | p. 351 |
| Books and Reports | p. 352 |
| U.S. Food and Drug Administration (FDA) Publications | p. 352 |
| Standards | p. 353 |
| Web Sites | p. 353 |
| Webinars on CD | p. 353 |
| U.S. Courses | p. 354 |
| Tools | p. 354 |
| Index | p. 355 |
