Medical Device Labeling Design

The medical device company I work for has a hands off CEO who is also in charge of marketing, because of this I got put in charge of labeling. The text is mostly straightforward, just follow the FDA labeling guidance and requirements. The design is not so much straightforward, other company's labels provide inspiration, but I suspect if things get serious the labels will be redesigned quickly enough. In fact, a couple of the labels we sent out with the validation load for sterilization had the wrong product name, the company decided to rename the product four months before planned 510(k) submittal. This doesn't matter because they were samples and we are testing if the ink runs and do the labels stick through sterilization, things which are independent of the design. Although if push came to shove, the standard label materials have been through sterilization millions of times, so you could probably justify not sterilizing them for validation.

These labels aren't cheap and there are more of them around than you think. Most small medical device companies don't print their own labels and there are plenty of label printers around. I've used three label companies lately, all are fairly similar, the one not in California is a bit cheaper, but really they're all close. Save yourself some money and get a copy of Adobe Illustrator right off the bat, some label companies will do some (usually minimal) work for free, but others will charge you. Chances are if you can draw it in another program, you can draw it just as easy in Illustrator. For each label there is a setup fee that is about $35-$100 and maybe a dye charge of $50-$100. Each color adds cost, so make sure you really want the full color logo with the green and yellow star or whatever in it. Small quantities makes for some goofy pricing. For labels for disposables you'll end up with something like 1,000 labels for $600 or 10,000 labels for $650. Permanent labels for multiple use devices can also add up quickly and start at $20 each and you don't want to order less than ten or you'll pay the setup fee again later on. On the start up project I'm working on I'll probably end up spending more than $10,000 all told on the first batch of labels (not including the printer)- a cost that will probably be the same next year for things like moving and redesigns.

One of the complaints I have about labeling is that I can't get anyone to look at anything before the printing company sends a proof. I'll send around a label eight times and everyone will say its great, then once they get a proof in their hands its can we change that from "Battery Light" to just "Battery" and make everything in all capital letters. This is a style pet peeve of mine and I am in a constant war with the all caps people at my company. In some guidance document that I probably linked above it says one of the ways to make labeling stand out is to have it in all caps, however it is my belief that if EVERYTHING is in caps it negates this and thus only very important information should be all caps, plus I think it just looks bad. Anyway, caps rant aside, the label makers seem to understand, but I can change something in four minutes, waiting for a new proof takes more time.

The most challenging aspect of labeling is labeling control, which I'll save that for another post (now posted here).