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.
Contents
Machine generated contents note: 1. Introduction to Contextual Inquiry / Mary Beth Privitera -- 1.1. Background and Introduction -- References -- 2. Planning a CI Study for Medical Device Development / Mary Beth Privitera -- 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 -- 2.5. Internal Review Board Requirements for CI -- 2.6. Protocol Development -- 2.7. Conducting a CI Study OUS -- 2.8. Best Practices -- References -- 3. Contextual Inquiry Methods / Mary Beth Privitera -- 3.1. Contextual Inquiry Methods -- 3.2. Approaches to Observation -- 3.3. Interviews -- 3.4. Best Practices -- References -- 4. Executing and Documenting a CI Study / Mary Beth Privitera -- 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 -- 5. Data Analysis / Mary Beth Privitera -- 5.1. Overview -- 5.2. Tools for Data Analysis -- 5.3. Data Condensation -- 5.4. Ethics -- 5.5. Best Practices -- References -- 6. Developing Insights / Mary Beth Privitera -- 6.1. Developing Insights for Design -- 6.2. Review, Share, and Organize -- 6.3. Best Practices -- References -- 7. Data Visualization and Communication / Mary Beth Privitera -- 7.1. Overview -- 7.2. Types of Data Visualization -- 7.3. Communicating Findings -- 7.4. Best Practices -- References -- Case Study Introduction -- 8. A CI Study in Cerebral Angiography for Product Development Strategy and Clinical Training / Andrew Ringer -- 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 Flow They Were Met -- 8.8. Conclusions -- 9. BioMarker Strategies SnapPath® Case Study: Design Research Program to Integrate a Breakthrough Diagnostic System into the Clinical Environment / Tor Alden -- 9.1. Introduction -- 9.2. Process -- 9.3. User and Environment Immersion -- 9.4. Verifying Assumptions -- 9.5. Summary -- Acknowledgments -- 10. Contextual Inquiry as a Tool for Medical-Device Development: The Case of Harmonic Focus / Stephen B. Wilcox -- 10.1. Introduction -- 10.2. Methodology -- 10.3. Conclusion -- Acknowledgments -- References -- 11. Using CI to Inform Design Development of an Incision and Drain Packing Device for Use in Emergency Medicine / Mary Beth Privitera -- 11.1. Introduction and Background -- 11.2. Methodology -- 11.3. The Results -- 11.4. Conclusions -- Acknowledgments -- References -- 12. Quick Reference and FAQ / Mary Beth Privitera -- 12.1. Introduction.
