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Usability Testing of Medical Devices [Kietas viršelis]

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  • Formatas: Hardback, 412 pages, aukštis x plotis: 234x156 mm, weight: 726 g, There will be a 16-page color insert fo follow page 202; 23 Tables, black and white; 126 Illustrations, black and white
  • Išleidimo metai: 20-Dec-2010
  • Leidėjas: CRC Press Inc
  • ISBN-10: 1439811830
  • ISBN-13: 9781439811832
Kitos knygos pagal šią temą:
  • Formatas: Hardback, 412 pages, aukštis x plotis: 234x156 mm, weight: 726 g, There will be a 16-page color insert fo follow page 202; 23 Tables, black and white; 126 Illustrations, black and white
  • Išleidimo metai: 20-Dec-2010
  • Leidėjas: CRC Press Inc
  • ISBN-10: 1439811830
  • ISBN-13: 9781439811832
Kitos knygos pagal šią temą:
To paraphrase a popular saying, usability testing should be done early and often. However, it doesnt have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devices provides 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.
Acknowledgments xi
How to Use This Book xiii
The Limitations of Our Advice xv
Who Could Use This Book? xvii
About the Authors xix
Chapter 1 Introduction
1(24)
What is Usability Testing?
2(5)
What is a Medical Device?
7(3)
Class I General Controls
8(1)
Class II Special Controls
9(1)
Class III Premarket Approval
9(1)
Why Conduct Usability Tests of Medical Devices?
10(2)
What are Common Regulator Comments on Test Plans?
12(4)
Is Usability Testing of Medical Devices Required?
16(3)
Do You Have to Test Minor Design Changes?
19(2)
How Do You Defend Usability Testing Methods to Market Researchers?
21(1)
Notes
22(3)
Chapter 2 Risk Management and Usability Testing
25(14)
What is the Relationship between Usability Testing and Risk Management?
26(2)
Can Usability Testing Identify Use-Related Hazards?
28(2)
What is a Dangerous Use Error?
30(5)
Is Usability Testing a Reliable Way to Assess the Likelihood That a Dangerous Use Error Will Occur?
35(1)
Notes
36(3)
Chapter 3 The Commercial Imperative
39(10)
How Does Testing Affect the Development Schedule?
40(3)
Does Usability Testing Offer Liability Protection?
43(3)
Can You Develop Marketing Claims Based on Test Results?
46(2)
Note
48(1)
Chapter 4 Testing Costs
49(14)
What Should a Request for Quotation for Usability Testing Include?
50(4)
What Does a Usability Test Cost?
54(6)
What is the Return on Investment?
60(3)
Chapter 5 Anatomy of a Usability Test
63(26)
What are the Common Elements of a Usability Test?
64(6)
What is the Proper Duration of a Test Session?
70(3)
Do You Have to be a Usability Specialist to Conduct a Test?
73(2)
Does it Take a "Brain Surgeon" to Evaluate Medical Devices?
75(4)
Why Test if You Cannot Change the Design?
79(2)
How Do You Set Expectations?
81(3)
What Can Postpone a Usability Test?
84(4)
Note
88(1)
Chapter 6 Types of Tests
89(18)
What is the Difference between Formative and Summative Usability Testing?
90(3)
What is a Benchmark Usability Test?
93(3)
What is an "Out-of-the-Box" Usability Test?
96(2)
Can a Test Session Include More Than One Participant?
98(3)
Can You Conduct a Group Test?
101(3)
How Do You Conduct a "Quick-and-Dirty" Usability Test?
104(1)
Notes
105(2)
Chapter 7 Writing a Test Plan
107(14)
What Should a Test Plan Include?
108(2)
Does Usability Matter to Regulators?
110(4)
Do Usability Test Plans Require Institutional Review Board Approval?
114(4)
How Do You Protect Intellectual Property?
118(1)
During Test Planning
118(1)
During Recruiting
118(1)
During the Usability Test
118(1)
Notes
119(2)
Chapter 8 Choosing a Participant Sample and Recruiting Participants
121(30)
What is an Appropriate Sample Size?
122(2)
Can Advisory Panel Members Play a Role in Usability Tests?
124(2)
Should Children Participate in Usability Tests?
126(3)
Should Seniors Participate in Usability Tests?
129(3)
How Do You Conduct a Usability Test Involving People with Impairments?
132(5)
How Do You Recruit Test Participants?
137(1)
Set an Appropriate Compensation Level
137(1)
Ensure a Good Cross-Section
138(1)
Make the Activity Sound Worthwhile
139(1)
Avoid Frauds
139(2)
How Do You Recruit Physicians?
141(2)
How Do You Recruit Nurses?
143(2)
How Do You Prevent No-Shows?
145(2)
How Do You Recruit Laypersons?
147(2)
Notes
149(2)
Chapter 9 Test Environments
151(22)
What is the Benefit of Testing in a Medical Environment Simulator?
152(4)
How Do You Test in Actual Use Environments?
156(4)
Should You Test in a Participant's Workplace?
160(4)
Can You Conduct a Usability Test over the Web?
164(4)
Can You Test a Device While it is in Actual Use?
168(2)
What if a "Device" Cannot Be Moved?
170(3)
Chapter 10 Adding Realism
173(30)
Why and How Do You Distract Test Participants?
174(3)
What Use is a Mannequin?
177(4)
What Role Can a Standardized Patient Play?
181(2)
How Do You Simulate Invasive Procedures?
183(3)
How Do You Simulate Blood?
186(3)
How Do You Simulate Skin and Injections?
189(3)
How Do You Simulate Impairments?
192(5)
How Do You Simulate Hardware Interactions?
197(2)
How Do You Simulate Other Medical Devices?
199(2)
Notes
201(2)
Chapter 11 Selecting Tasks
203(40)
Do You Have to Test Everything?
204(2)
What Tasks Should Test Participants Perform?
206(3)
Why Focus on Potentially Dangerous Tasks?
209(2)
How Do You Choose Tasks When Evaluating Use Safety?
211(2)
Should Tests Include Maintenance and Service Tasks?
213(2)
Can You Test Long-Term Usability?
215(3)
How Do You Test Alarms?
218(2)
How Do You Test Warning Labels?
220(3)
How Do You Test Instructions for Use?
223(3)
How Do You Test Symbols?
226(3)
How Do You Test Legibility?
229(6)
How Do You Evaluate Packaging?
235(3)
How Do You Test the Appeal of a Device?
238(2)
Notes
240(3)
Chapter 12 Conducting the Test
243(40)
What is the Value of Pilot Testing?
244(2)
Who Should Observe the Test Sessions?
246(4)
What Kinds of Usability Problems Arise during a Usability Test?
250(6)
What Can Go Wrong before, during, and after a Test?
256(3)
What Risk Do Test Personnel Assume?
259(3)
Are There Times When the Testing Staff Should Be All Female or all Male?
262(2)
Should User Interface Designers Conduct Usability Tests of Their Own Designs?
264(2)
When and How Should You Assist Test Participants?
266(3)
Can You Modify a Test in Progress?
269(3)
Can You Reliably Detect Use Errors?
272(2)
Can You Give Test Participants Training?
274(4)
Should You Provide Access to Learning Tools?
278(3)
Notes
281(2)
Chapter 13 Interacting with Participants
283(16)
When is it Appropriate to Ask Participants to Think Aloud?
284(3)
What is the Proper Way to Pose a Question?
287(2)
Is There a Place for Humor in a Usability Test?
289(2)
How Do You Minimize Participant Fatigue?
291(2)
How Do You Protect Participants from Harm?
293(3)
What if the Test Participant Gets Hurt?
296(2)
Notes
298(1)
Chapter 14 Documenting the Test
299(12)
What Data Should You Collect?
300(4)
What Use are Task Times?
304(2)
What is a Good Way to Video Record a Session?
306(3)
How Do You Video Record Participants' Interactions with a Moving Device?
309(2)
Chapter 15 Analyzing Test Data
311(10)
What Kind of Statistical Analyses are Most Useful?
312(5)
Case 1
312(1)
Case 2
312(1)
Case 3
312(1)
Case 4
313(1)
Case 5
313(4)
How Do You Handle Outliers?
317(2)
Note
319(2)
Chapter 16 Reporting Results
321(18)
What Makes a Good Test Report?
322(4)
Should Test Reports Include Design Recommendations?
326(3)
Can Usability Test Results Be Misleading?
329(3)
How Do You Deliver Bad News?
332(1)
Example 1
333(1)
Example 2
333(1)
How Do You Explain a Lack of Statistical Significance?
334(2)
What Makes a Good Highlight Video?
336(2)
Notes
338(1)
Chapter 17 Validation Testing
339(12)
How Does Design Validation Differ from Design Verification?
340(1)
Design Verification
340(1)
Design Validation
340(2)
Can a Clinical Trial Supplant Summative Usability Testing?
342(2)
Usability Evaluations during Clinical Use
344(2)
Can You Conduct a Usability Test in Parallel with a Clinical Trial?
346(2)
Can You Conduct a Summative Usability Test without Conducting a Formative Usability Test?
348(1)
Notes
349(2)
Resources
351(4)
Books and Reports
352(1)
U.S. Food and Drug Administration (FDA) Publications
352(1)
Standards
353(1)
Web Sites
353(1)
Webinars on CD
353(1)
U.S. Courses
354(1)
Tools
354(1)
Index 355
Wiklund Research & Design, Inc., Concord, Massachusetts, USA Wiklund Research Design, Concord, MA