We all love to celebrate wins and milestones, while we hide, ignore, or bemoan our failures. That is unfortunate because failures are a necessary part of growth and success. The same is true with designing MedTech and Devices.
With careful observation in the field, we can spot workarounds that lead to new approaches to solve a problem. What is a workaround? It has been defined as “circumvent or temporarily ‘fix’ perceived workflow hindrances to meet a goal or to achieve it more readily.” In a 2018 study by ECRI Institute, workarounds were #4 in their Top 10 list of patient safety concerns.
Workarounds may be hard to spot, even when they are in plain sight. First, you need careful observation of patients or HCPs engaged in the treatment, breaking it down into simple steps. Actions that are not in line with the DFU are potentially a place for a new solution or an updated design. This may result from the use occurring in a different environment than intended, such as a patient’s home instead of a medical setting.
Of course, devices are designed iteratively. Often the 1st user testing is a reaction to a paper concept, or an animation. After an initial device is designed, a prototype can be tested, which may be non-working, partially working, or fully working. In the user testing, the problems encountered lead to a better design. The next design version can be tested to examine how well it works and what other problems are encounter. This design-test-redesign iteration may go on for a few rounds. Of course, after launch, new versions can be created that add new features and enhanced design.
Mistakes and workarounds are the fertile ground for better design and innovation! We should celebrate failures that lead to better solutions. Obviously, we want to be sure that a medical device is safe and effective before it is in the hands of end-users, and that is why the FDA mandates validation studies.