I constantly find myself trying to draw parallels between my work life and personal life in almost everything I do and while I work in Quality and Regulatory for medical device manufacturers, I enjoy spending downtime playing fantasy football. Being that this weekend was the Championship round for the NFL I began some reflection. I found myself realizing that fantasy football has similarities to writing a technical file for a medical device.

Going back to my humble fantasy football beginnings, I truly thought fantasy football was nonsense and a waste of time. Then the next thing I know my best friend from college "needed" a 10th owner for his league. Reluctantly, I agreed to join his league, but only for this season. I was adamant about being one and done. Then I began researching. Magazines, the internet, television, all were researched in the name of fielding a quality team. I had to assess the risks associated with taking one player over another and formulate a strategy of when I was strong enough with one aspect of my team, and I needed to round out another portion. All in the name of having the strongest and most risk adverse team possible.

My humble beginnings with fantasy are similar to my humble beginnings with regulatory affairs for medical devices. I was asked to create a technical file (something that I had never done before, but had some experience working with others on). As I began work on writing a technical file for a medical device I found parallels with my fantasy football beginnings. Where I listened to podcasts for fantasy advice, I researched the Maude Database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm). Where in a fantasy draft I needed to assess Arian Foster vs. Adrian Peterson, writing a technical file requires research in what the competition has experienced in the way of reportable events. In my fantasy draft I strategized whether a Quarterback is more valuable than a running back, the technical file required an understanding of what Verification and Validation testing is required based on the intended use of the product and the risks associated with not performing the testing. Where I strategized what player to draft in a particular round knowing that if I don't select them now they will not be there when it was my turn the next time around, I learned to work with the client on what risks are acceptable to take and which should be mitigated by taking a more conventional route. Both fantasy football and regulatory affairs involve understanding risk, formulating a strategies and executing to the plan.

Medical devices technical files and Fantasy Football both require tons of research and hard work, but if you execute correctly you will be rewarded with a winner, whether that be a championship or a marketable medical device. Both are fun and can be extremely gratifying if you just take the time to look at it as something that parallels something you enjoy in your own life. That's what I did with treating the technical file as preparing for a fantasy draft. Now only if my fantasy teams would have performed as well as the technical file...

- MJB

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