How to use the FDA Process to Deliver a User-Friendly Medical Device
Seasoned medical device developers know that the FDA cares about safety and effectiveness, and nothing more. And because of the intense focus required to meet stated FDA expectations, it’s easy to put on blinders regarding issues outside the immediate frame of reference.
Device developers that fall into this trap are surely missing a key element that will drive marketplace success: the vital need for their product to ensure a delightful user experience.
Let’s think for a minute about what the FDA asks of you. Safety and effectiveness are just table stakes, the price of admission. EVERY medical device on the U.S. market is presumably safe and effective. Your only competitive advantage and point of differentiation is how much more you can make someone like your device over a competitor’s.
No doubt, some will perceive this notion to be controversial. There’s a common mindset that medical devices are serious products, to be used by highly skilled serious professionals, and getting the job done is all that matters. In my opinion, users are just people, whether they are wearing a sweater or scrubs. They want to enjoy what they are doing and they want it to be as easy and painless as possible.
A New Way of Thinking
I offer a path forward for those that do agree or are at least open to a new way of thinking. A new way to use the FDA medical device standards you are accustomed to already.
The term “use error” is used throughout many standards and it’s the manufacturer’s responsibility to reduce the chances (read: risk) of a user making a mistake that could harm anyone involved. The process requires you to imagine all the ways a person might interact with your device, and reduce the chances (read mitigate the risk) of them making an error.
The FDA is basically requiring you to spend hundreds or thousands of hours in a very specific way, to avoid errors and guarantee safety. The problem is that no one is required to spend any time at all to avoid frustrations and guarantee a great user experience.
Unfortunately, a user experience standard or requirement doesn’t exist. If it did, it might look something like IEC 62366 (Part 1 application of usability engineering in medical devices) but it would focus on mitigating the risk of frustrations instead of use errors.
The phrase “use error” can be found 115 times in the standard. By simply substituting the phrase “use error” with “frustration” and “hazardous situation” with “bad experience,” the standard takes on an entirely new meaning. Here are three examples of how it might read with those changes:
Based on the identified user interface characteristics and use specification, the manufacturer shall identify the use errors frustrations that could occur and are related to the user interface.
The data from the summative evaluation shall be analyzed to identify the potential consequences of all use errors frustrations that occurred. If the consequences can be linked to a hazardous situation bad experience, the root cause of each use error frustration shall be determined. The root causes should be determined based on observations of user performance and subjective comments from the user related to that performance.
Some user interface designs contribute to user errors frustrations because they employ non-intuitive, counter-intuitive or hard-to-learn displays or controls. The consequences of such design flaws often only become apparent when the user is using the medical device in an emergency or stressful situation, is fatigued, or uses the medical device only rarely.
Summing Up
There is so much more to designing a successful medical device than ensuring the safety of people that encounter it. The all-consuming regulatory approval processes and never-ending technical challenges during the medical device design process make this difficult to remember.
I challenge you to expand your horizons. It’s not enough for you to know the FDA standards, speak the lingo and blindly follow stated requirements.
If you follow my prescription to use the FDA process as an opportunity to deliver a superior experience, your customers and the marketplace will take note and reward you accordingly.
