It Just Might be a Medical Device

If you are among the one or two people on this Earth who’ve never heard of Jeff Foxworthy, I guess I’ll need to clue you in.  I didn’t think there was anybody in that category, but, as you’ll see in a minute, I was wrong.

I’m a huge Foxworthy fan.  He’s funny!  And never demeaning…well, unless you need to be demeaned.  Jeff is the guy who came up with the “You might be a redneck if…” jokes.  Like, “If you’ve ever been too drunk to fish, you just might be a redneck”.

The connection between Jeff Foxworthy and this blog came about when our company was asked to provide training/consulting for a large research university.  We were to assist their commercialization department with new medical devices that their researchers were developing.  They wanted to make sure that the development of these devices complied with FDA regulations.

I had to admit that regulatory training could be deadly boring.  There had to be a way to keep people awake during the videos that we were recording.  I was racking my brain trying to figure out a way to explain that whether FDA regulations apply to a new device depends on the application.  If the intended use is to treat or diagnose a disease, it’s a medical device and FDA has to be involved.   If not, then no.

About that time, I turned on the TV and saw a Foxworthy rerun.  The light went on.  The solution was clear.

The next week I’m in the university recording studio giving my schpiel.  The studio was small but professional.  The manager of the commercialization department was in the soundproof booth along with the engineer.  I felt like I was doing about as well as a retreaded chemist could do, looking into the camera, enunciating clearly, and advancing my slides.

Then I got to my favorite part:  “So, how do you know whether the new device that you’re developing needs to be approved by FDA?

“Well, here’s an example.  Let’s say you have invented a new device:  The Key.  Now, if the purpose of The Key is simply to open doors, it’s not a medical device and FDA does not get involved.  But, if the intended use of The Key is to clean wax out of your ears, it just might be a medical device!

At that point the door to the soundproof booth exploded open and the manager burst into my face.  Much to my surprise, she was not rolling on the floor laughing.  “You can’t say that.  You have to re-record it.”

“Why,” I said.  “Did you think it was inappropriate?  I was just channeling Jeff Foxworthy.”

“My boss never heard of Jeff Foxworthy.  You have to re-record that!”

I glared at my customer for far too long before finally agreeing to re-record the segment.  There is no doubt that few, if any, of the researchers who had to endure that training remained conscious to the end.

We all live in our own little worlds, I guess.  To this day I’m still trying to wrap my mind around the concept that somebody had never heard of Jeff Foxworthy.

How about you?  Do you have a similar story?  Can you suggest a good way to teach critical thinking?  Comment below.

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