Ethnographic Field Research (recommended in the FDA Guidance)—also called contextual inquiry or observational research—involves real-world observation to determine the facts on the ground regarding product users, use environments, and procedures or processes. It establishes a factual record of what actually takes place to inform product development and provides unique insights into user needs.

Design Science conducts ethnographic research in a variety of environments, including:

  • Clinical environments, including procedure labs, patient floors, operating rooms, and more.
  • Home environments, including studying people during sleep as well as in waking hours.
  • Public places, including use environments such as restaurants and recreation areas, as well as retail environments.
  • Workplaces, particularly for the development of tools that people use to perform their jobs.

Design Science’s ethnographic research is characterized by:

  • Extreme rigor, to go beyond anecdotal data to real actionable information, including various types of quantitative, as well as qualitative, data.
  • In-context interviews to yield insights beyond those afforded by observation alone or by more conventional interviews.
  • Information graphics to present complex information in ways that are easily accessible and actionable and that illuminate patterns.

Tools:

  • Proprietary portable, high-resolution, multi-camera video recording systems.
  • Unique video systems for capturing hard-to-obtain footage, including head-mounted cameras, portable overhead cameras for dynamic plan views, infrared cameras for recording in dark conditions, and hidden cameras for recording in public places (of course, with participants’ permission).
  • A system for conducting video conferencing in people’s homes.
  • Physiological measurement devices for capturing, for example, stress levels during procedures.