AUTHOR: Thomas Stokes, PhD – Human Factors Engineer – EG-GILERO
When it comes right down to it, if you are making medical devices, performing good user research and formative studies in addition to validation studies is the smart choice. User research and formative studies give you valuable insights about your users, their tasks, the environment that your device will be used in, and how early prototypes might perform in that user/task/environment combination. Without a good understanding of these qualities you cannot properly design for your end users, and are far less likely to have a product that performs well in validation tests.
For some there seems to be reservation about doing this ‘extra’ research. It seems that a lot of these hesitations are based around misconceptions that user research and formative studies are difficult to conduct, and/or potentially expensive endeavors. In reality these research activities don’t have to be complicated, can be done using discount methods, and have good return on value.
Research doesn’t have to be difficult or expensive
Research does not have to be expensive or complicated to give you valuable information about your users. With both user research and formative human factors studies the requirements (e.g. sample sizes, choice of methods) are looser than validation studies; this gives a product team flexibility to run studies less formally, more quickly, and using discount methods.
User research (research into target users, key tasks, and task environment) methods are designed to gather a great amount of information very quickly (e.g. surveys can get statistically meaningful numbers of results in as little as a day), and sometimes with very few participants (e.g. interviews and focus groups can garner rich qualitative information using as few as 5-8 target users). Using these methods, a project team can develop user profiles and user needs requirements that guide product ideation, and develop meaningful design considerations.
Similarly, formative studies (human factors/usability studies on products still being designed) can be done informally, with smaller sample sizes. Using a small number of participants, one can find many of the usability problems with an in-development device; the quick feedback from these small-n studies allows a product team to iteratively improve devices, and reduce usability issues with relatively low cost.
They key is remembering to keep your research lean, and knowing how to focus your research efforts so that they yield results with actionable outcomes and design inputs.
User research is worth the investment
User research and formative studies are a low cost (and extremely effective) way of driving development of a usable product but the benefits are not limited to actionable design inputs. This type of research has a track record of returning value on investment1,2,3. A few reasons for this include:
More likely to pass summative evaluation– Medical devices need to be able to pass a summative, validation human factors assessment. Devices that have been carefully designed with respect to usability are more likely to pass summative evaluation. If a design team opts to skip user research and formative testing they run the very real risk of failing, and having to re-run a summative study. Would you rather run two expensive summative studies, or run a cheaper, formative study and only summative study? In the end skipping user research and formative studies to cut corners in your budget can end up costing you more than if you had made room for them to begin with.
Reduction of litigation– Poor usability can lead to errors with a device, and these errors can lead to costly lawsuits for a device manufacturer. Conducting proper usability testing and designing based off well-conducted user research reduces your likelihood of errors in market and, in turn, reduces likelihood of a lawsuit on your hands.
Usability increases adoption– There are several factors that influence a person’s decision about what technologies or products they use, usability being a particularly notable one 4. Usable devices are more likely to be adopted and used relative to less usable devices. So, increased usability can improve the market success of a product, and ultimately make the difference between which product succeeds between competitors.
In summary, if you aren’t performing user research, and/or don’t have budget allocated to formative usability studies you should change that. These research activities are proven methods of developing a better product that is more likely to help your target-users, and have an established track record of returning good value on investment. Both you and your users will be happy that you made a commitment to user research.
 Nielsen, J. Return on investment for usability. Nielsen Norman Group. https://www.nngroup.com/articles/return-on-investment-for-usability/
 Nielsen, J. Usability ROI declining, but still strong. Nielsen Norman Group. https://www.nngroup.com/articles/usability-roi-declining-but-still-strong/
 Wiklund, M.E. (2005). Return on investment in human factors. Medical Device & Diagnostic Industry, 27, 48-55.
 Davis, F.D. (1985) A technology acceptance model for empirically testing new end-user information systems: Theory and results. (Doctoral dissertation, Massachusetts Institute of Technology).