Sep 15, 2007

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).


Rolande said...

You and I have had similar experiences in the packaging and labelling arena.
Keep writing, I enjoy reading your blog.

Labelling Terminology (and spelling) sometimes changes when we cross the Atlantic.

In the UK and Ireland a Permanent label is one which is - Typically not designed to be removed without tearing the label stock or using solvents.
Our label permanency applies to the method of securing the label. Can you confirm that when you refer to a 'Permanent Label' this is a form of tag or plate that remains as identification of a piece of equipment throughout its working life?

JCK said...

My terms are a little sloppy.

I'm referring to permanent labels as labels that will be permanently on a long term device- such as a computer or other electronics.

Labels for disposables are designed to last the life of the product but obviously don't require the ability to go through washings and the like.

JCK said...

I changed the wording around to clarify some!

Andrew Dallas said...

Interestingly labeling now carries over to user interface elements of medical devices. Among other things, it's very important to get vocabulary correct for device display such that there is no confusion about whether or not the device is making a diagnostic claim. Thankfully there are many techniques available. For instance, it may be considered diagnostic to show a green or red icon whereas a yellow or blue icon would be considered indicative but not diagnostic. It's important to take these into account when designing user interfaces as color schemes can get pretty ugly when color changes need to be made later in the process.

Cassie said...

Thanks for the posts on medical device labels. Do you have any advice for labels that have stickers integrated? The stickers could be printed with barcodes and product ID to be peeled off and stuck onto patient records? I'm looking for a company that can produce something like that.

Thanks for your help!

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Stewart said...

I am sure that working and having responsibility in labeling is really difficult. We must be creative in labeling especially in creating labeling design, mustn't we? Do you design the label design on your own?

Charles said...

It seems to me that most of the problems you're encountering would be solved by having a printer in-house. Specifically the latter points about the reviewing of received labels. With an in-house printer couldn’t you just print off a label and show it to your higher-ups that day? The initial cost of label printer may be high, but the savings in time over time are certainly worth the investment. Not to mention your cost-per-label is high. 600 for 10000 labels is above average, and 600 for 1000 labels is simply astronomical. That would be significantly reduced with an in-house printer.