Medical Device Commercialization Overview
Conducting User Research
Who are your users?
Understanding user needs is critical in guiding medical device development. FDA regulations require, in fact, that the design of a medical device be tested to validate that the product conforms to defined user needs and intended uses.
Conducting research with users will identify the product characteristics that users consider most important. Done correctly, it will also provide the designers with an understanding of the various ways users might interact with the product in the environment and under the real conditions in which it will be used.
Can medical device development be undertaken without a user research study? Yes. But then what you think you know about users will simply be conjecture. That is a risk. Further, user research will often reveal surprises that challenge what you think you know about users. That can uncover learnings that can lead to valuable innovation.
Forma can help you gain an in-depth understanding of your users by employing various research methodologies such as focus groups, one-on-one interviews, dyad interviews, shadowing, and direct observation of procedures. We can help in all phases of a research project: For research preparation, we can design the study, develop research materials and aids such as questionnaires and facilitator guides, and recruit participants.
For conducting the study, we can develop product prototypes, models, product illustrations, instructions for use, concept sketches, and screen simulations.
For analysis of the research, we can review and analyze the data, utilizing our extensive experience to add insight to the research findings. Of course we can also conduct any follow up research that is required.
For presentation of the research results, we can develop communication materials that clearly and effectively explain the learnings from the research, and recommend opportunities and direction for product development efforts ahead.