When I was in high school, I was a speech geek. Every Saturday during the Forensics season I got up before the crack of dawn, met up with my speech and debate team, and drove to a different local school to compete in a public speaking tournament. The category I competed in primarily was Original Oratory, which required each student to write an original persuasive or informative 10-minute speech, memorize it (preferably before the tournament if you harbored any hope of escaping public humiliation), and deliver it in front of a room full of peers and judges. I know it sounds like torture, and every Saturday morning when I woke up at 5 AM, I asked myself why I couldn’t have a normal hobby like so many of my other friends. My brain doesn’t function well enough at 5 AM to have that conversation, so I ended up doing Forensics all 4 years of high school. I spent long hours doing research and crafting my speeches, but although they were coherently structured, well-substantiated, and (I thought) interesting, initially my scores were pretty disappointing. As I watched some of the more experienced students in competition though, I learned that how I presented my speech was just as important as what I was actually saying.

This concept has many broader applications if you think about it. If you’re designing a medical device that is meant to display information to the user, how that information is presented greatly impacts how the user will process it and react to it. As an obvious example, many infusion pumps have some form of air detector which will trigger an alert on the user interface if an air bubble over a certain size is detected. Usually the alert is both visual and audible, and it’s certainly attention grabbing! The LEDs that flash aren’t pastel colors and the warning tones aren’t exactly soothing. There are standards that govern the presentation of this alarm information so that the attending nurse is much more likely to recognize the air alert from the offending infusion pump and look into potential causes.

Submissions to the FDA or other regulatory bodies are another area where presentation of key information makes a big difference. Sending a copy of every document produced during development of your device might make FedEx your best friend, but burying your reviewers in documentation won’t make them very happy and will likely confuse them. If all of the necessary evidence (without extraneous documentation) is presented logically in the submission, reviewers will have a much easier time finding what they need and they’ll have fewer questions. Take the usability file for example. If your usability documentation clearly shows how you identified and mitigated use-related risks and then validated the effectiveness of those mitigations, the review process will be much simpler.

The power of presentation is only one of the valuable life lessons I learned as a member of the National Forensic League (that’s right, it’s the other NFL). I also learned to set multiple alarm clocks, but that’s another story…

-KB

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