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.
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:
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.
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:
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.
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.