Ethnographic Research & Medical Devices Design

Used correctly, ethnographic research can provide hard data for guiding a device company’s business decisions.

Ethnographic research, such as observing the setup of a catheter, often leads toideation. But it can also lead to significant device design.In 2001, William Reese and I wrote an article about the use of ethnographic research for the development of new medical devices.


In that article, we described what ethnographic research is and why it is a useful tool for identifying user wants and needs for medical devices. The article looked at the limitations of device users’ descriptions of what they do and what they need, and it explored how ethnographic research can transcend those limitations. It also discussed how ethnographic research differs from conventional market research in employing direct, real-world observation of device use.
That article examined how ethnographic interviews, which take place in the environment of device use, can yield richer and more-accurate information than interviews conducted at a neutral site (and usually conducted long after the behavior of interest has taken place). Finally, it described some of the characteristics of ethnographic research, such as spending significant amounts of time in the environment of use, working to develop rapport with informants, and carefully considering the context in which procedures take place.
The use of ethnographic research has since become much more common in medical device development. However, its relative ubiquity raises an important issue: How can ethnographic research achieve validity? By validity, I mean the degree to which the research findings accurately describe the real-world facts that they purport to describe.
The issue of validity does not always apply to ethnographic research, at least not to all research to which the term ethnographic is applied. Much so-called ethnographic research—perhaps most of it—is designed simply to generate ideas, that is, to stimulate creativity. Inevitably, when members of device-design teams go into the field and see directly how their devices and other devices are used, it generates insight and stimulates new ideas. This is certainly a reasonable and productive purpose for field research.
However, there is another, perhaps more ambitious, purpose to which ethnographic research can be applied—to guide business decisions regarding new product development, e.g., to determine what new devices are needed, what characteristics new devices should have, and so on. What “guiding business decisions” amounts to, of course, is providing information to determine how millions, or tens of millions, or even hundreds of millions of R&D dollars can be most productively spent.


Observing activities such as the note-taking process can reveal crucial steps in a user’s methods.


Much of what people do is largely unconscious, and, ironically, this is more true as one becomes more skilled. For example, novice surgeons may be conscious of the position of their hands at a particular point in tying sutures. Experienced surgeons are more likely to be thinking about the next step of the procedure or even where they are going to have lunch. Also, it is well known that people tend to answer questions in ways that reflect positively on themselves or that tell the questioner what he or she appears to want to hear, often at the expense of strict accuracy.
There is plenty of room for observational research of device users that does not purport to yield a true picture of reality, but rather simply provides interesting and useful fodder for ideation. However, when the research is intended to be used to guide device-development decision making, particularly in the medical area, it is crucial that the validity of the research be carefully addressed.


* Stephen Wilcox is the founder and a principal of Design Science (Philadelphia). He can be reached at sbw@dscience.com.


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