By Tom KraMer, president and CEO, Kablooe Design
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:
- Make sure you watch what users do, and not just listen to what they say. A lot of good information regarding user needs can be gleaned through user interviews, but that only goes so deep. So much more is learned by watching what they do, then asking “why?” after they have done it. Record these activities, and you will begin to uncover some important user needs.
- Find the little needs surrounding the big need. We can easily focus on the single, big need, but we must do more than that to deliver a truly innovative solution in the end. For instance, your big need might be to improve the performance of a certain minimally invasive surgical tool. Focusing on that tool is obvious. But what about the environment it’s used in, the table it is on, the nurses and techs that interface with it, the setup and maintenance, and the perceptions and expectations of all these users and the constraints of those environmental factors? Paying attention to these things in research will help you to uncover many small needs surrounding that initial big need. Addressing these will lead to innovative solutions.
- Look at the procedure as a series of chronological task blocks. Don’t just watch the whole procedure as one event. Ask yourself what the users need to do to be successful in each of those blocks and look for things that trip them up. These things can be turned into the user needs that you must address. We have found that you can focus on and find many more things if you are looking at sections of a procedure and procedures in themselves, instead of viewing the whole procedure as one event.
Once your new fabulous medical device is further down the development road and you have a designed concept, you can match your design outputs to these inputs and if they match, you have just completed your design verification step! It’s a three for one: If you smartly conduct your design research, you can then get design inputs, a formative study, and design verification results. Matching the outputs to the inputs is the main activity of your design verification testing and is done by evaluating the use of your design to determine if all the features of your designed device are delivering the intended results that the requirements defined. These tests are part of your design controls process, and they involve testing the functional activities of your device with users and recording the results. Using your early design research to act as a formative study and provide design input data can save you weeks of development time versus waiting to do more formal formative studies later down the road to gather that data.
Shaving time off development schedules is nice, but the rewards for this kind of thinking and practice go deeper than that. By developing design inputs from early research activities like this, deeper insights are formed earlier in the process that show what kinds of things may make the device or system more successful with users. These things can be tested in more early design research and that insight deepens, enhancing the chances for continued, deeper innovation. This is also helping to de-risk the process early by making sure the concepts being pursued are more closely matched to the users’ needs. And if the users’ needs are met at a higher level, the chances for success in the marketplace are increased.
Be smart. Properly document a deep, robust design research process. And reap the rewards.
About The Author:
Tom KraMer, president and CEO of Kablooe Design, has been a product innovator for over 30 years. He holds a certificate in master of product development from Northwestern University and a bachelor’s degree in industrial design from the Minneapolis College of Art and Design (MCAD), as well as a certificate from Stanford University’s Cardiovascular System in Health and Disease program. KraMer has created revenue for countless customers by delivering innovative product solutions to their portfolios. He spearheaded the D3 Process (Design Driven Development), a vehicle to provide these results to customers, and he teaches this process by traveling as a lecturer and speaking about innovation and development processes.