By Corinna Proctor, MS
The FDA and ANSI/AAMI/IEC 62366-1 provide guidance on the device design process and where human factors formative studies fit in, and what is expected. If the agency sees your submission with no Formative usability work, your submission may be ‘flagged.’
After many years in the business, we are still seeing go-to-market timelines without sufficient time carved-out for Formative studies and making necessary updates (to the device or labeling or the training program) prior to the proposed Validation Test time frame. Sometimes we hear: “We’ll run a quick Formative prior to Validation” – but this mindset can be problematic. We think of your Formative studies as your training ground for the marathon (the Validation Test); and most people would not run a marathon without training.
We all understand the goal – to show safe and effective use of your product or system. The Human Factors Engineering (HFE) file tells the story of where you started and where you landed, based on user research input (Formative studies, early design studies and exploratory research) and the iterative changes you’ve made to incrementally enhance safe and effective use. Your Formative studies are the main tool for measuring and demonstrating success along the way.
“But how many Formatives will we need?” It depends of course, but plan for two and put some space between them. If you don’t need two, fine, no one complains about shortened time frames, but the converse is typically not true. You may need more than two. But the program timelines could shift if Formative studies are not accounted for up front. How many you “really need” depends on several factors including: results from the Formative studies, the timing of and feasibility of updates, and changes and readiness of features at various timeframes. Some companies run six or seven (or more) Formative studies prior to the Validation Test because they are studying and updating the design along the way.
“And when do I do these?” The first Formative study should be planned as the first developmental models of your product or system are ready. You don’t need high fidelity perfection for your first Formative. You’re here to ask yourself is this [system], generally, the right one for our users? And are we even on the right path?
Formative study results will drive inputs to your Use-Related Risk Analysis (URRA) and second (or third or fourth) Formative studies are often required as updates to the URRA, the design or labeling or new user groups are defined.
Bottom line: lean on and plan-out your Formatives in your program schedule. In our eyes, Formative studies are some of the most important tools you can apply during your development process.