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A Review of Contextual Inquiry for Medical Device Design (Book Review)


Glass Cage book coverA review of

Contextual Inquiry for Medical Device Design

by Mary Beth Privitera

Book website


About this book

A good reference for Methods/How-To, Case Studies
Primary audience: Researchers and designers with some or significant experience with topic
Writing style: Matter-of-fact with equal parts text and images
Publisher Elsevier Academic Press, 2015, 284 pages, 12 chapters

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The United States Food and Drug Administration (FDA), as well as international regulators, now require manufacturers of certain types of medical devices to follow a rigorous user-centered approach to the design of their products. Over the past few years I’ve started to do more work with physical products and have developed an interest in medical device usability. Short of poring through reams of ponderous FDA regulations, it’s been hard for me to get a clear sense of the new guidelines. Thus, I was delighted to come across this book because it provides a comprehensive explanation of how to do usability research for medical devices in an interesting and absorbable way. Through good writing and well-designed diagrams this book demonstrates how to carry out and document user research during the formative stage of medical device design so your work synchronizes with the FDA Design Control Process.

The author, Mary Beth Privitera, is a professor at the University of Cincinnati and co-director of its Medical Device Innovation & Entrepreneurship Program. Privitera focuses on how to do user research for medical devices using Holtzblatt’s contextual inquiry (CI) approach. However, the CI techniques she describes could be applied to UX work in any industry. She argues that CI is the most appropriate method for user research for medical devices because the research is focused on product design and the process “enables the research team to observe and interact with all users and study the social and environmental dynamics that can play a role in new device development.”

Privitera provides an in-depth explanation of contextual inquiry, as well as how the results synchronize with the FDA requirements. If done right, CI will produce organized, traceable and defensible details on user needs, context of use, key tasks and risks.

The book’s content is organized into four sections: pre-study, data collection, data analysis, and organizing findings.

  • Pre-study: Pre-study work involves getting up to speed on the particular device via background research so that the CI inquiry can start at a more advanced level. During this phase the team also develops the protocol, recruitment strategy, and other aspects of the research design. The team gets certifications needed to observe procedures such as sterilization techniques needed to be in an operating room. Pre-study work also involves reaching out to Institutional Review Boards as well as key people from the sites they will visit.
  • Data collection: For data collection, Privitera describes how to interview medical staff and observe them during a procedure. This provides valuable detail, including where to position tools like video cameras. This section also contains templates and examples that you can adapt for your studies for tasks such as interviewing, note-taking, projective exercises and participant consent forms.
  • Data analysis: Data analysis, insights, and data visualization from a CI study happen simultaneously beginning with coding the findings to identifying a theme, which is a “dominant behavior, idea, or trend seen throughout a site visit.” These codes form the backbone of the analysis, which goes more quickly if you categorize them as “Initial Reaction” for observer impressions, “Descriptive” to flag themes related to tool use, “Emotional” and “Value and Belief” to identify when a participant expressed feelings or values around using the tool, and “Sequential” to identify insights connected to a particular task. In addition to coding approaches, the book includes examples of how to organize findings along a timeline.
  • Organizing findings: For reporting, user needs are condensed into individual “Theme Maps,” with each map focused on one need. Each Theme Map contains a photograph depicting the need, a description of the challenge, mitigation, and recommended design. The Theme Maps are assembled into a “Procedure Map,” which is a complete visualization of the results from the CI project.

Overall, this is one of the best-designed and most valuable UX books I have read. It successfully boils down a very complex topic and makes it easier to learn. I especially liked the “Quick Reference and FAQ” chapter at the end that summarizes the book’s content. Aside from fixing a few typos, the next edition could be made even better by also providing a Glossary of Terms and acronyms, as well as a companion website with templates and full-screen examples of Procedure Maps.

“Contextual Inquiry for Medical Device Design” serves as both a practical guide for field studies and a reference that I will return to for guidance again and again. I highly recommend this book to usability professionals and medical device designers. It should also be useful for anyone with an interest in medical devices or contextual inquiry regardless of whether they have a background in usability, consumer research, or product design.


Book Excerpt: About the FDA Design Control Process

The book begins with an overview of the FDA Design Control Process, which formalizes the user-centered approach to product design. The process begins with identifying user needs, which become the “design inputs” to the product specification. The “design outputs” are the product features and characteristics that map to specific user needs. The purpose of contextual inquiry is to identify user needs in enough detail to drive the product design. Formative usability assessment begins during the prototyping stage and ends when the product design is mostly complete. At this point the manufacturer validates the design through summative usability testing. Throughout the formative phase the manufacturer identifies and documents risks for potential use errors through the formative usability evaluations. The focus of the summative usability testing is to validate that the product design reduces or mitigates the potential for use errors.




Executing and Documenting a CI Study: Best Practices

  • Plan on arriving 15-30 minutes before a scheduled observation. Clinical sites are often a maze and difficult to navigate.
  • Ask if there is a dedicated place for belongings. Only bring what you absolutely need.
  • No one will wait for researchers; we cannot interrupt patient care.
  • If you feel faint or ill, tell someone sooner rather than later.
  • Passing out happens. No one expects it and everyone is embarrassed
  • by it. It is OK. You might end up being admitted to the emergency


  • Cases may get cancelled in last minute, be patient.
  • Cases can be mis-communicated. This is rare, but does happen. Try to

reschedule an appropriate case to observe.

  • Keep a dedicated bag with all the recording supplies.
  • Have each person be responsible for maintaining their own data:
  • collecting, transcribing, and coding.
  • Document all the visits in a standard manner, and possibly use standard

QMS procedures for maintaining the documents for inclusion of the

design history file.

  • Dress accordingly with comfortable shoes.