Research for Medical Product Design
User research is critical in medical product design due to the health and wellness implications of design decisions. It is also required by the FDA as part of its medical product design guidelines.
Conducting user research across the great variety of medical device users, tasks and environments requires a broad knowledge of methods and tools in the medical product design industry. This can range from field observation of a specialized procedure with world-leading surgeons to identify design opportunities, to surveying a broad base of healthcare consumers to evaluate an in-use medical product. Consequently, expertise in user research is essential for choosing and applying the right techniques in the context of medical product design and development. Bresslergroup’s medical research practice employs qualitative and quantitative methods, combined with state of the art technology for efficient data gathering, analysis and presentation which is vital in the medical product design process.
At the core of all our methods is the focus on studying the most appropriate end-user for the medical product design. A critical activity at the start of every medical device design project is the definition and recruitment of the research participants. This is accomplished through a review of current customer and market data, combined with expertise in human factors trends. For example, as a larger proportion of female surgeons enter the field, there is a need to accommodate relative differences in hand size in the medical product design of instruments. Consequently, female surgeons would need to be represented appropriately in ergonomic research activities.
We also consider different user levels in our participant recruitment including behavioral differences between novices and experts before implementation of the medical product design. We also consider lead users, who, while not representative, can demonstrate pioneering techniques that can subsequently influence the processes used by others in their field.
A frequent question in conducting qualitative research is “how many participants?” Rather than focusing on rigid sample sizes, Bresslergroup determines appropriate participant numbers through a combination of user characteristics, project goals and task complexity.
Our years of experience and long-term relationships with specialized medical recruiters, provides us with access to the appropriate end-users across specialties and medical conditions, both in the United States and internationally. User research participants play a huge role in determining how to proceed with the medical product design.
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