05658nam 2200649 450 991079713300332120200520144314.00-12-801852-6(CKB)3710000000418685(EBL)2060808(OCoLC)910662589(SSID)ssj0001535979(PQKBManifestationID)11860617(PQKBTitleCode)TC0001535979(PQKBWorkID)11508643(PQKB)10717576(MiAaPQ)EBC2060808(Au-PeEL)EBL2060808(CaPaEBR)ebr11062010(CaONFJC)MIL792438(PPN)198687079(EXLCZ)99371000000041868520150619h20152015 uy 0engur|n|---|||||txtccrContextual inquiry for medical device design /Mary Beth Privitera, University of Cincinnati and Know Why Design, LLC Cincinnati, Ohio, USA ; contributors, Tor Alden [and six others]First edition.Amsterdam, [Netherlands] :Academic Press,2015.©20151 online resource (307 p.)Description based upon print version of record.0-12-801874-7 Includes bibliographical references at the end of each chapters and index.""Front Cover""; ""Contextual Inquiry for Medical Device Design""; ""Copyright Page""; ""Contents""; ""List of Contributors""; ""Foreword by Thomas Fogarty""; ""Foreword by Peter Curry""; ""Foreword by William S. Ball""; ""Foreword by Arthur Pancioli""; ""Preface""; ""Acknowledgments""; ""1 Introduction to Contextual Inquiry""; ""1.1 Background and Introduction""; ""1.1.1 CI or Ethnography?""; ""1.1.2 Purpose and Rationale""; ""1.1.3 Background of MDD""; ""1.1.4 When is CI Completed in MDD""; ""1.1.5 Uses of CI in MDD""; ""CI can Determine Usability Objectives through the Study of Behaviors""""CI can Assist in Developing Business Strategy""""Similarities and Differences to a Clinical Trial""; ""1.1.6 Arguments for or Against Conducting CI""; ""â€œWe Know Our Customer. We Do Not a Formal Study to Tell Us What We Already Knowâ€?""; ""â€œIt Is Too Costlyâ€?""; ""â€œParticipants are a Painâ€?""; ""â€œThe Data Collected Is Overwhelming and I Have No Idea What to Do with Itâ€?""; ""â€œIt Takes Too Long and We Cannot Afford the Time for a Studyâ€?""; ""1.1.7 Starting Off with a CI Study Makes Sense""; ""References""; ""2 Planning a CI Study for Medical Device Development""""2.1 Overview of CI Study""""2.2 Preparation and Setting the Background""; ""2.2.1 Beginning where Others Left Off""; ""2.2.2 Conduct Secondary Research""; ""2.3 Kick-Off Meeting""; ""2.4 Determine Appropriate Target Sites and Participants (Inclusion Criteria)""; ""2.4.1 Sample Size""; ""2.4.2 Clinical Site and Potential Participant Determination Process""; ""2.5 Internal Review Board Requirements for CI""; ""2.6 Protocol Development""; ""2.6.1 Contents of a Protocol""; ""2.6.2 Background and Overview""; ""2.6.3 Objectives""; ""2.6.4 User Profile or Inclusion/Exclusion Criteria""""2.6.5 Methods for Data Collection""""2.6.6 Study Materials Required""; ""2.6.7 Data Management Plan""; ""2.6.8 Target Schedule""; ""2.6.9 Protocol Template Example""; ""2.6.10 Toward Rational Design of the Humanâ€?Device Interface in Catheter-Based Interventions: A CI Study""; ""Unmet Need""; ""Project Description""; ""Milestones""; ""Resources""; ""2.7 Conducting a CI Study OUS""; ""2.8 Best Practices""; ""References""; ""3 Contextual Inquiry Methods""; ""3.1 Contextual Inquiry Methods""; ""3.1.1 Overview""; ""3.2 Approaches to Observation""; ""3.2.1 Overt Observation Approach""""3.2.2 Think Aloud Approach""""3.2.3 Use Simulation with Reflection""; ""3.2.4 Role-Playing Approach""; ""3.2.5 Note Taking: Specific CI Observational Measures to Consider""; ""3.3 Interviews""; ""3.3.1 Interviewing Approaches""; ""3.3.2 Semi-Structured Approach""; ""3.3.3 Unstructured Approach""; ""3.3.4 Narrative Interview""; ""3.3.5 Good Interview Techniques""; ""Establish a Rapport with the Study Participant""; ""Know what Questions to Ask""; ""Avoid Asking Leading Questions""; ""Only ask one question at a time and then wait patiently""; ""Avoid Questions that are too Open""""Include Questions of HOW, WHY, WHEN, FOR WHAT PURPOSE"" Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technologyHelps users Medical instruments and apparatusDesign and constructionContext effects (Psychology)Medical instruments and apparatusDesign and construction.Context effects (Psychology)610.284Privitera Mary Beth1581619Alden TorMiAaPQMiAaPQMiAaPQBOOK9910797133003321Contextual inquiry for medical device design3863264UNINA