Dec 3, 2007

Medical Device IFU and Manual

I mentioned previously that I was working on our Operator's Manual and this post is an extension of that. Our manual and Instructions for Use (IFU) are detailed and thorough and go above and beyond what others in the field have done for a number of reasons.

First off, there is patient safety to think about. A picture or sketch goes much further to describe something than plain text. I'm lobbying to get our software to include videos of various steps. I haven't gotten very far with this yet, sometimes its a struggle to not get everything written in all caps.

Second, we're eventually trying to make sales, why skimp on the manual? Frustrated users cost sales- saving the $5 by printing in black and white and limited documentation is not where you want to cut costs. Established devices can skimp, they've been around for years, everyone already knows how they work. Not us, we need to educate people, mostly everything works the same, but there are some subtle differences. Sure, no one may ever read the manual, but if they do, its only going to make them unhappier if they don't find what they're looking for.

Third, this is 2007, I can snap a picture, edit it, and stick it in the manual in about 3 minutes, likewise with sketches, everything has been drawn in Solidworks, it is not a problem to make a nice little line drawing of anything I could ask for. I can also format things exactly how I imagine them, not to take advantage of these capabilities would be foolish.

Fourth, it is something I enjoy for the most part, which helps.

I say go overboard with this stuff, someone can always remove part later if they find something disagreeable. In the past I was rather amazed at things clinical users did not know, now I am more cynical. We've talked to quite a few people that can't differentiate IV bag sizes. It was a decent struggle to tell a three liter bag from a one liter bag and even after explaining it was still not 100%. We solved this problem by going with one bag size.

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