We attended a medical device manufacturing event in San Antonio a couple weeks back.  The organizers were either smart or sadistic when they chose the venue, depending on your point of view.  We were held captive in a golf resort northwest of town, a $40 cab ride (one way) from the earthly pleasures of Riverwalk.  Early morning attendance was greatly increased but unless you wanted some high end retail experiences the location was a bit sterile.

When we arrived on Sunday we were also informed that, on a NFL Sunday, the bar did not open until 4pm and did not have NFL Sunday Ticket.  It was a sullen and demoralized crew that watched the exciting Jacksonville/Jets game.  Still, we were there for the advancement of medical device manufacturing knowledge and intelligent discourse on the issues.  It was a fairly high level group, yours truly excepted, but most of the attendees were well aware of labeling issues for terminally sterilized packaging and one of the issues that everyone has is the lack of  label real estate.

Our record at Advanced Web is 27 languages on one label.  My guess is that it will increase rather than decrease in the future.  Symbols, both EN 980 and ISO 15223 can help with the space management, translation costs, and lengthy lead times associated with the translation process. As most people know, a company can create and use its own symbols as well as long as they are explained, in 27 languages of course, in the IFU.

The printed IFU itself might go away when E Labeling is finally allowed in the EU, a rare instances where the FDA is ahead of the innovation curve on this type of issue.  As the Medical Device Directive and the Packaging Waste Directive trade body blows, toe to toe in the EU arena, I can’t help but wonder the impact on labeling when this logical, cost effective, and green alternative to pitching a 48 page booklet in the dumpster is authorized.  My guess would be that with the information being electronic or on a disk, more information will be needed on the package labeling.

Unique Device Identification is another requirement that is coming down the pike. The Global Harmonization Task Force released its final rule on global UDI about 2 weeks ago. No matter how the program is implemented it will require valuable label real estate to implement.  Other standardization efforts are in the works as well.  There is an initiative in ASTM to come up with a standard labeling format for arthroplasty.  A guy I know even wrote an article in PMP News on the topic this month.  Once again the content of the label will need to be manipulated, in both instances for well thought out and progressive reasons, but nonetheless it’s certain to use up more label space.

So what’s the answer?  Heck, I don’t know, I’m just a label guy who kicks out a blog now and then.  One thing would be more symbols and more standardized symbols.  There are plenty of things that are consistent across the board whether you are making pacemakers or spinal implants.  Size matters as well.  All of the devices I’m discussing are used by medical professionals; grandma doesn’t have to read the verbiage with her +4.00 cheaters.  Six point type is readable, especially if you use a good, readable font such as Helvetica.  Stay away from the serif typefaces, the cute little fonts favored by more artistic types, with curly Q’s and lines that vary in thickness throughout the stroke of the character.

Adding real estate is another solution.  ‘They ain’t makin’ any more land’ is the common wisdom when you’re complaining about the cost of real estate acreage but it’s not true with label acreage.  The size of the label on the package can be maxed out.  On a four foot long introducer lead this is not a problem, on a relatively small pacemaker package it can be, which is a key issue with any standardization that is applied across the board.

Things such as expanded content labels, the little accordian fold booklets seen on many small packages, are one way to increase space for label verbiage.  Lots of questions but minimal answers at this time.  Varying package sizes need to be considered when developing standards that apply to everything.  Symbols should be the first ‘go to’ solution, and well designed and laid out labels should be the norm.  Think of your living room when guests are coming, not the closet you just threw all the crap from the living room into.  Finally expanded content or even simple two sided printing of the labels helps add real estate.  No matter how much you need now, it’s pretty apparent that more will be needed in the future. It’s not too early to begin strategizing.