Usability Testing of Medical Devices

ISBN-10: 1439811830
ISBN-13: 9781439811832
Edition: 2010
List price: $53.99
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Book details

List price: $53.99
Copyright year: 2010
Publisher: CRC Press
Publication date: 1/28/2011
Binding: Hardcover
Pages: 412
Size: 6.00" wide x 9.00" long x 1.00" tall
Weight: 1.584
Language: English

Wiklund Research Design, Concord, MA

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

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