Usability Testing of Medical Devices (Record no. 39716)

MARC details
000 -LEADER
fixed length control field 07317nam a22001937a 4500
003 - CONTROL NUMBER IDENTIFIER
control field OSt
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781466595880
082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 621.381548 WIK-U
100 ## - MAIN ENTRY--PERSONAL NAME
Personal name Wiklund, Michael
245 ## - TITLE STATEMENT
Title Usability Testing of Medical Devices
250 ## - EDITION STATEMENT
Edition statement 2nd
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc London
Name of publisher, distributor, etc CRC Press
Date of publication, distribution, etc 2016
300 ## - PHYSICAL DESCRIPTION
Extent 455p.
500 ## - GENERAL NOTE
General note Introduction<br/>What is usability testing?<br/>What is a medical device?<br/>Why conduct usability tests of medical devices?<br/>What is a use error?<br/>What is a close call?<br/>What is a difficulty?<br/>What are common regulator comments on summative (i.e., validation) test plans?<br/>Is usability testing of medical devices required?<br/>Do you have to test minor design changes?<br/>How do you defend usability testing methods to market researchers?<br/>References<br/><br/>Risk management and usability testing<br/>What is the relationship between usability testing and risk management?<br/>Can usability testing identify use-related hazards?<br/>What is a dangerous use error?<br/>Is usability testing a reliable way to assess the likelihood that a dangerous use error will occur?<br/>Do you have to evaluate every risk mitigation?<br/>References<br/><br/>The commercial imperative<br/>How does testing affect the development schedule?<br/>Does usability testing offer liability protection?<br/>Can you develop marketing claims based on test results?<br/>Reference<br/><br/>Testing costs<br/>What should a request for quotation for usability testing include?<br/>What does a usability test cost?<br/>What is the return on investment?<br/><br/>Anatomy of a usability test<br/>What are the common elements of a usability test?<br/>What is the proper duration of a test session?<br/>Do you have to be a usability specialist to conduct a test?<br/>Does it take a "brain surgeon" to evaluate medical devices?<br/>Why test if you cannot change the design?<br/>How do you set expectations?<br/>What can postpone a usability test?<br/>What ethical dilemmas might arise?<br/>Reference<br/><br/>Types of tests<br/>What is the difference between formative and summative usability testing?<br/>What is a benchmark usability test?<br/>What is an "out-of-the-box" usability test?<br/>Can a test session include more than one participant?<br/>Can you conduct a group test?<br/>How do you conduct a "quick-and-dirty" usability test?<br/>Are there special considerations when testing a "legacy" device?<br/>References<br/><br/>Writing a test plan<br/>What should a test plan include?<br/>Does usability matter to regulators?<br/>Do usability test plans require IRB approval?<br/>How do you protect intellectual property?<br/>Must a regulator approve a summative usability test plan?<br/>References<br/><br/>Choosing a participant sample and recruiting participants<br/>What is an appropriate sample size?<br/>Can advisory panel members play a role in usability tests?<br/>Should children participate in usability tests?<br/>Should seniors participate in usability tests?<br/>How do you test a device used jointly by a child and parent?<br/>How do you conduct a usability test involving people with impairments?<br/>How do you recruit test participants?<br/>How do you recruit physicians?<br/>How do you recruit nurses?<br/>How do you recruit laypersons?<br/>How do you prevent no-shows?<br/>References<br/><br/>Test environments<br/>What does building a usability test laboratory entail?<br/>What is the benefit of testing in a medical simulation facility?<br/>How do you test in actual use environments?<br/>How does testing a home health care device differ from testing a device used in clinical settings?<br/>Should you test in a participant’s workplace?<br/>Can you conduct a usability test over the Web?<br/>Can you test a device while it is in actual use?<br/>How do you conduct a nocturnal test?<br/>What if a device cannot be moved?<br/>Reference<br/><br/>Adding realism<br/>Why and how do you distract test participants?<br/>What use is a mannequin?<br/>What role can a standardized patient play?<br/>How do you simulate surgical procedures?<br/>How do you simulate blood?<br/>How do you simulate skin and injections?<br/>How do you simulate impairments?<br/>How do you simulate hardware interactions?<br/>How do you simulate other medical devices?<br/>References<br/><br/>Selecting tasks<br/>Do you have to test everything?<br/>What tasks should test participants perform?<br/>How do you make tasks flow naturally?<br/>Why focus on potentially dangerous tasks?<br/>How do you choose tasks when evaluating use safety?<br/>What if there are no high risks?<br/>How do you assess risk control measures associated with very unlikely use errors?<br/>How do you assess effectiveness?<br/>Should tests include maintenance and service tasks?<br/>Can you test long-term usability?<br/>How do you test alarms?<br/>How do you test warning labels?<br/>How do you test instructions for use?<br/>How do you test symbols?<br/>How do you test legibility?<br/>How do you evaluate packaging?<br/>How do you test the appeal of a device?<br/>How do you prioritize tasks?<br/>Is there value in directing participants to repeat tasks?<br/>References<br/><br/>Conducting the test<br/>What is the value of pilot testing?<br/>Who should observe the test sessions?<br/>What kinds of usability problems arise during a usability test?<br/>What can go wrong before, during, and after a test?<br/>What risks do test personnel assume?<br/>Are there times when the testing staff should be all female or all male?<br/>Should user interface designers conduct usability tests of their own designs?<br/>When and how should you assist test participants?<br/>Can you modify a test in progress?<br/>Can you reliably detect use errors?<br/>Can you deliver training to test participants?<br/>Should you provide access to learning tools?<br/>References<br/><br/>Interacting with participants<br/>When is it appropriate to ask participants to think aloud?<br/>What is the proper way to pose a question?<br/>Is there a place for humor in a usability test?<br/>How do you minimize participant fatigue?<br/>How do you protect participants from harm?<br/>What if the test participant gets hurt?<br/>References<br/><br/>Documenting the test<br/>What data should you collect?<br/>What use are task times?<br/>What is a good way to video record a session?<br/>How do you video record participants’ interactions with a moving device?<br/><br/>Analyzing test data<br/>What kind of statistical analyses are most useful?<br/>How do you handle outliers?<br/>What role does root cause analysis play?<br/>References<br/><br/>Reporting results<br/>What makes a good test report?<br/>Should test reports include design recommendations?<br/>Can usability test results be misleading?<br/>How do you deliver bad news?<br/>How do you explain a lack of statistical significance?<br/>What makes a good highlight video?<br/>References<br/><br/>Validation testing<br/>How does design validation differ from design verification?<br/>Do you need to conduct a test prior to filing for an investigational device exemption?<br/>Can a clinical trial supplant summative usability testing?<br/>Can you conduct a usability test in parallel with a clinical trial?<br/>Can you conduct a summative usability test without conducting a formative usability test?<br/>References<br/><br/>Instructors<br/>We provide complimentary e-inspection copies of primary textbooks to instructors considering our books for course adoption.<br/><br/>Share this Title<br/>
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Applied physics
856 ## - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="https://books.google.co.in/books?id=DB5CH9U0Zp0C&printsec=frontcover&dq=usability+Testing+of+Medical+Devices+by+wiklund&hl=en&sa=X&ved=0ahUKEwiJ_uLRuszhAhXx7nMBHQ6yCk4Q6AEIKDAA#v=onepage&q=usability%20Testing%20of%20Medical%20Devices%20by%20wiklund&f=false">https://books.google.co.in/books?id=DB5CH9U0Zp0C&printsec=frontcover&dq=usability+Testing+of+Medical+Devices+by+wiklund&hl=en&sa=X&ved=0ahUKEwiJ_uLRuszhAhXx7nMBHQ6yCk4Q6AEIKDAA#v=onepage&q=usability%20Testing%20of%20Medical%20Devices%20by%20wiklund&f=false</a>
901 ## - LOCAL DATA ELEMENT A, LDA (RLIN)
Acc. No. 27419
942 ## - ADDED ENTRY ELEMENTS (KOHA)
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    Dewey Decimal Classification   Not For Loan Reference Amity Central Library Amity Central Library Biomedical 10/05/2018 SBA 5469.00 SBA / 12160 31/03/2018   621.381548 WIK-U 27419 10/05/2018 https://epgp.inflibnet.ac.in/UploadedContent.php 10/05/2018 Reference Book
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