Contextual Inquiry for Medical Device Design
- 1st Edition - June 1, 2015
- Latest edition
- Editor: Mary Beth Privitera
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 0 1 8 5 2 - 1
- eBook ISBN: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
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 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
Medical device industry professionals in design, engineering, marketing and regulatory; students in industrial design, design research, and biomedical engineering
- 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
- Edition: 1
- Latest edition
- Published: June 1, 2015
- Language: English
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Mary Beth Privitera
Dr. Mary Beth Privitera, M.Design, FIDSA, is internationally known as an expert in medical product design, specifically in the area of applied human factors. She is a Professor at the University of Cincinnati’s Department of Biomedical Engineering and works collaboratively among the Colleges of Medicine, Engineering and Design. She is a consultant to the medical device industry with expertise in user interaction design and human factors. Additionally, she serves as faculty and co-chair of the Association for the Advancement of Medical Instrumentation’s Human Engineering Committee.
As a Professor at the University of Cincinnati’s Department of Biomedical Engineering, she is a Co-Founder of the Medical Device Innovation and Entrepreneurship Program. Her previous academic appointments include industrial design and in the Department of Emergency Medicine.
She has worked on devices which are intended for use across the practice of medicine and in home health situations. Her current research focuses on applied ergonomics and design interpretation. She has conducted contextual inquiry studies throughout the hospital with results intended to inform the design of devices, including physiologic monitoring and clinical decision making, software-based tools including intraprocedural augmented reality. In addition, she currently has had research funding supported by the Gates Foundation and US FDA CDER Division. She is a Fulbright Scholar in collaboration with the University of Nottingham.
Affiliations and expertise
Director, Medical Device Engine, University of Cincinnati Medical Center, Cincinnatti, OH, USARead Contextual Inquiry for Medical Device Design on ScienceDirect