Contextual Inquiry for Medical Device Design - 1st Edition - ISBN: 9780128018521, 9780128018743

Contextual Inquiry for Medical Device Design

1st Edition

Editors: Mary Beth Privitera
eBook ISBN: 9780128018743
Paperback ISBN: 9780128018521
Imprint: Academic Press
Published Date: 1st June 2015
Page Count: 310
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Description

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.

Key Features

  • 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

Readership

Medical device industry professionals in design, engineering, marketing and regulatory; students in industrial design, design research, and biomedical engineering.

Table of Contents

  • 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

Details

No. of pages:
310
Language:
English
Copyright:
© Academic Press 2015
Published:
Imprint:
Academic Press
eBook ISBN:
9780128018743
Paperback ISBN:
9780128018521

About the Editor

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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