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Contextual Inquiry for Medical Device Design
1st Edition - May 29, 2015
Editor: Mary Beth Privitera
Language: English
Paperback ISBN:9780128018521
9 7 8 - 0 - 1 2 - 8 0 1 8 5 2 - 1
eBook ISBN:9780128018743
9 7 8 - 0 - 1 2 - 8 0 1 8 7 4 - 3
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…Read more
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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 technology
Helps users understand the everyday use of medical devices and the way their usage supports the development of better products
Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process
List of Contributors
Foreword by Thomas Fogarty
Foreword by Peter Curry
Foreword by William S. Ball
Foreword by Arthur Pancioli
Preface
Acknowledgments
Chapter 1. Introduction to Contextual Inquiry
1.1 Background and Introduction
References
Chapter 2. Planning a CI Study for Medical Device Development
2.1 Overview of CI Study
2.2 Preparation and Setting the Background
2.3 Kick-Off Meeting
2.4 Determine Appropriate Target Sites and Participants (Inclusion Criteria)
2.5 Internal Review Board Requirements for CI
2.6 Protocol Development
2.7 Conducting a CI Study OUS
2.8 Best Practices
References
Chapter 3. Contextual Inquiry Methods
3.1 Contextual Inquiry Methods
3.2 Approaches to Observation
3.3 Interviews
3.4 Best Practices
References
Chapter 4. Executing and Documenting a CI Study
4.1 Overview
4.2 Expectations in the Field
4.3 Anticipated Challenges and Potential Solutions
4.4 Program Management
4.5 Considerations before Entering the Field
4.6 Developing a Data Management Plan
4.7 Field Etiquette
4.8 Best Practices
Reference
Chapter 5. Data Analysis
5.1 Overview
5.2 Tools for Data Analysis
5.3 Data Condensation
5.4 Ethics
5.5 Best Practices
References
Chapter 6. Developing Insights
6.1 Developing Insights for Design
6.2 Review, Share, and Organize
6.3 Best Practices
References
Chapter 7. Data Visualization and Communication
7.1 Overview
7.2 Types of Data Visualization
7.3 Communicating Findings
7.4 Best Practices
References
Case Study Introduction
A CI Study in Cerebral Angiography for Product Development Strategy and Clinical Training Mary Beth Privitera & Andrew Ringer, MD
BioMarker Strategies SnapPath® Case Study: CI Study to Integrate a Breakthrough Diagnostic System into the Clinical Environment Tor Alden
Contextual Inquiry as a Tool for Medical-Device Development: The Case of Harmonic Focus Stephen B. Wilcox, PhD, FIDSA
Using CI to Inform Design Development of an Incision and Drain Packing Tool for Use in Emergency Medicine Mary Beth Privitera
Chapter 8. A CI Study in Cerebral Angiography for Product Development Strategy and Clinical Training
8.1 Background
8.2 Methodology
8.3 Data Analysis and Findings
8.4 Designing the Information for Analysis and Communication
8.5 Determining Product Development Opportunities
8.6 Clinical Involvement and the Development of Seminar-Friendly Training Manuals/Interactive Tool
8.7 The Challenges and How They Were Met
8.8 Conclusions
Chapter 9. BioMarker Strategies SnapPath® Case Study: Design Research Program to Integrate a Breakthrough Diagnostic System into the Clinical Environment
9.1 Introduction
9.2 Process
9.3 User and Environment Immersion
9.4 Verifying Assumptions
9.5 Summary
Acknowledgments
Chapter 10. Contextual Inquiry as a Tool for Medical-Device Development: The Case of Harmonic Focus
10.1 Introduction
10.2 Methodology
10.3 Conclusion
Acknowledgments
References
Chapter 11. Using CI to Inform Design Development of an Incision and Drain Packing Device for Use in Emergency Medicine
11.1 Introduction and Background
11.2 Methodology
11.3 The Results
11.4 Conclusions
Acknowledgments
References
Chapter 12. Quick Reference and FAQ
12.1 Introduction
Index
No. of pages: 310
Language: English
Edition: 1
Published: May 29, 2015
Imprint: Academic Press
Paperback ISBN: 9780128018521
eBook ISBN: 9780128018743
MP
Mary Beth Privitera
Privitera’s research focus is in collaborative medical device design and the application of human factors in design. She is a member of the Association for the Advancement of Medical Instrumentation Human Factors Committee and has coauthored various sections in HE 75 and recently a TIR on Contextual Inquiry. To date, she has been associated with more than 40 product releases, holds several patents and provisional patents, and has published and lectured on a variety of topics including design research, transdisciplinary/collaborative design, innovation methodology, and surgical techniques.
Affiliations and expertise
Director, Medical Device Engine, University of Cincinnati Medical Center, Cincinnatti, OH, USA
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