Design & User Research
Design and user research lead to the catalysts that make innovation possible. Research helps us “defuzz” the front end of product development.
Early in the design process, insights into unmet needs expose opportunities. This is Generative Research. Evaluative Research plays a major role later on, when we test concepts using a variety of methods. Research drives distinct, effective decision-making and improvements at every juncture.
A high-level overview of a selection of research methods used during the design process.
Generative Research
The goal of research at the front end, or beginning, of the product development process, is to understand customers’ needs, wants, and frustrations, and how they might be better served by a product or service. These generative research methods uncover tangible, useful information that quickly becomes opportunities.
Generative Research Methods:
- Contextual Inquiry / Ethnographic Research: Contextual inquiry, also known as ethnographic research, is the study of users in their natural environment (home, office, hospital, etc.). Ethnography typically involves both observation without interruption and face-to-face interviews to clarify the observations. Contextual inquiry allows our researchers to view how the user’s environment impacts their performance and to observe work processes the user may not consciously be aware of, or able to verbalize. Being there is powerful, because it allows our researchers to see what people do — as opposed to what they say they do, or even what they think they do.
- Workflow Mapping: Workflow mapping identifies the steps and sub-steps users take in order to capture a holistic view of a task or process. Once completed, a workflow map can be used to identify pain points, bottlenecks, and ways that efficiency can be optimized.
- Diary Studies: Diary studies are a form of qualitative longitudinal research, where users self-report their activities, thoughts, and feelings at pre-determined intervals. Diary studies can include photos and videos and offer the advantage of being able to collect data in a user’s natural environment over several days or weeks, rather than at a single testing session. Diary studies designed around mobile platforms can be a very efficient way to connect to hundreds of users across broad geographies in a very short time.
All projects benefit — both in effectiveness of solutions and eventual time to market — when a team’s designers and engineers participate in the research process. In our multidisciplinary teams, all disciplines working on a project are kept abreast of new insights to newly inform and inspire ideation.
Evaluative Research
The concept testing and usability testing we do throughout product definition and development is part of our cross-disciplinary process, with continuous interplay between researchers, designers, and engineers. We rely on our in-house usability lab when we need quick, high-quality user feedback during generative to mid-stage evaluative research. Our in-house research, design, prototyping, and testing capabilities result in rapid and effective improvements. Storyboards, simulations, models, and mockups are created, evaluated, and matured, leading to higher fidelity models and building confidence in the right solution.
Evaluative Research Methods:
- Formative Usability Studies: Formative studies help inform the design of a device by gathering input from users before the design is finalized for production. Formative testing is typically conducted using product prototypes with representative users to identify strengths, weaknesses, and potential use errors that may occur while using a product. Sometimes various design options are tested against one another. Formative testing can be conducted as often as desired, with even just a few users, to better inform the design process. Conducting formative testing early and often is especially helpful in medical device design, where companies stand to save significant time and money before investing in creating final prototypes.
- Validation / Summative Usability Testing: Human factors validation testing might be done for submission to the FDA or other regulatory bodies (i.e., if the product is a medical device), or it might just be part of the product development process. Sometimes it is also called “summative testing,” and it is required to demonstrate that the production-ready product can be used by the intended users, for the intended uses, and under the expected use conditions. During medical device development, summative testing is needed to demonstrate that all the above can be done without causing harm or degrading medical treatment. A minimum of 15 users per user group (a set of users with distinct characteristics) must use the final product to perform critical tasks (tasks that could lead to medical harm) in a representative use environment. Any use errors or close calls observed are probed to understand the root cause and inform the risk management process to determine if further design changes are needed.
In general, evaluative research is especially vital for mission-critical, Rugged & Portable, and Medical Products where safety, efficacy, and performance can be a matter of life or death. The rigorous approach we’ve established for developing products in these specialty categories informs our consumer work. Similarly, our focus on usability and user experience for consumer products rubs off on our Medical Products development.
Research for Medical
Our researchers employ a wide array of techniques to help clients in medical and healthcare industries navigate the FDA’s human factors regulatory process, from initial product design to final validation testing. The FDA requires human factors and usability engineering to help maximize the ease of use, efficiency, and user satisfaction of every medical product. Medical device designers must conduct human factors validation testing to demonstrate that the intended users of a device can use the product to perform the intended uses in the intended use environment. The goal is to ensure that the device has been optimized to eliminate, or reduce to the furthest extent possible, use errors that could cause harm to a patient.
We have extensive experience executing user research that aligns with regulatory guidance and are well-versed in standards requirements, including: FDA Guidance 1757: Applying Human Factors and Usability Engineering to Medical Devices; AAMI/ANSI HE75:2009 Human Factors Engineering — Design of Medical Devices; AAMI/ANSI/IEC 62366-1:2015, CE marking (Europe); and Medical Devices Directive 93/42 EEC (Europe). Find out more about our research expertise in Medical Product Design.
