Analyzing How Devices Are Used

Contextual Inquiry for Medical Device Design, 1st Edition

Edited by Mary Beth Privitera, Academic Press, 2015, ISBN 9780128018521, xxii + 284 pages, US$106 paperback.

As a former design instructor, the title of this text interested me because I had not personally used the term contextual inquiry in my teaching, nor had I read it in literature. I found, from the back cover of the text, that “contextual inquiry, or CI, is a method of gathering information from a clinical setting on how devices are used, and what potential pain points there might be with what is currently available.” This was enough for me to be interested in reviewing it to see what I had been missing and how the text might be used in industry or the classroom.

The text consists of 12 chapters, most of which were written by the primary author, M.B. Privitera of the University of Cincinnati. The introductory chapter defines CI as “the analysis of interactions involving devices and people and the workplace,” and dates the initial use of the term to work published by Beyer and Holzblatt in 1998 or 1999. The focus in this chapter is the immersion, as far as possible, of the observer or designer in the milieu of use for the device being considered, either an initial design or a redesign, rather than in the noninteractive office of the device manufacturer. The primary objective of the immersion is to remove biases in a design or redesign process via an open study of the use of current devices and their shortcomings. Planning for such studies typically involves developing a team, estimating sample sizes and number of sites needed, possible Institutional Review Board approval processes, protocol and methodology development, data collection definitions, schedules, management, etc. (chapter 2). Data collection techniques often include collection of data observation of the user during a procedure, solicitation of verbal output from the user during a procedure, roleplaying after a procedure, interviews, etc. (chapter 3).

Chapter 4 covers some of the physical details that may be involved in a study, such as camera placements, confidentiality concerns, sterility considerations for the OR and other work, and honoraria. Data analysis considerations, such as descriptively coding events and properly placing data in a procedure time line, are discussed in chapter 5. This is the pivotal chapter for the text. Here, if done properly, data can be sorted so that observations may be noted, possibly mitigating problems in an ensuing analysis and design process. A caveat here is that the data are best analyzed as soon as possible, rather than at a later date.

Chapter 6 then suggests techniques for developing insights from this data and codifying it into design requirements and specifications. Chapter 7 explores data visualization (images, maps, templates, and sketches) and communication techniques (e.g., use of procedure maps for education). Chapters 8–11 are case studies (two involving the author) of angiography products, a cell testing system, a surgical tool, and a wound packing system (recommended). Finally, chapter 12, serves as a summary, quick reference, and frequently asked questions chapter.

For a designer in the medical device industry, this reviewer suggests this text if the reader has not been trained properly in the techniques used. It gives good insight into techniques that can be used to avoid bias in the design or redesign of medical devices.

For undergraduate biomedical design courses, this text is a useful reference, but needs much more effort from the publisher to serve as more. There are no color plates in the text: thus Figure 7.5, for example, which is purported to show back-bleeding, is virtually worthless. Multiple procedure maps, which in “real life” are 3 ft × 4 ft or more, are reprinted here at 3 in × 4 in, rendering them unreadable. The inclusion of color in the text, a CD, or website for the maps and storyboards would be helpful.