Is more design research putting the cart before the horse?

Design research can shorten the development process by making your FDA submission quicker and easier. Plus, you are making it more robust by doing the work now as opposed to later. Too many people wait until later in the process for this work and end up guessing on things or adding “filler” to their required usability data, which oftentimes the FDA can easily sniff out and flag. But by then it takes more time and money.

The point of design research is to provide the right information up front, so you can develop the best ideas early on. But nobody wants to spend the money to do it. It’s a Catch-22. Frank Lloyd Wright said: “You can use an eraser on the drafting table or a sledgehammer on the construction site.” The sledgehammer is a bit more expensive.

Design research actually minimizes project risk if you approach it correctly. What developers are ultimately trying to do with this research is understand what a user needs to do to be successful with the device. This helps create a thorough list of design criteria, but people seldom realize the immense value of this work. This criteria list can be leveraged to create design inputs, which is a necessary item for the eventual FDA submission. Also, if design research is documented correctly during the process, it becomes a robust formative study – another feather in the FDA hat. Here are some useful approaches for design research that will help drive success:

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