Editor's note: Tom Donnelly is vice president, head of medtech, at research firm Branding Science. Jason Mandelbaum is senior research executive at Branding Science. Hiba Rahman-Vyas is research executive at Branding Science.
This past year has been a challenging one for conducting research in person. While many types of projects have been successfully converted to virtual approaches with relative ease, observational research and hands-on work with medical devices and technology have proven to be more difficult. In this article we will: discuss traditional observational research approaches; mention the standard web-assisted telephone interview approach; detail advantages and disadvantages of three virtual observational approaches; and review two case studies: home health infusions and preparing/administering IV chemo. In our conclusion, we reflect on the need for observational research, point out the strengths of conducting research in phases and provide tips for success.
When designing a new medical device or modifying an existing one, observational research is used to observe workflows, workarounds and unmet needs. In market research, we may use the term ethnographic research, while in human factors we may call it contextual inquiry (CI). Regardless of what you call the approach, the idea is to watch health care practitioners or patients using the medical device. Using an observer-as-participant approach,1 there is an emphasis on observation, interjecting questions as needed for better understanding, as compared to active moderation during the use.
Trained medical moderators enter a medical environment – such as a hospital, an ambulatory surgery center or a pharmacy – to follow and observe medical personnel performing the procedures of interest. When the device is self-administered, patients are observed to better understand how they use their medical device. Moderators go to the patients’ homes...