As new medical devices are introduced to the market in ever-increasing numbers, it also becomes increasing critical to have effective, concise, brand identity-oriented messaging on their labels and packaging. Between sterile barrier issues, tamper indicating features, and FDA mandated label information, ensuring that the label and package both complement and advance a device manufacturers brand identity becomes more difficult and problematic. That’s why a label printer with industry experience and a team in place who knows how to balance the competing issues is critical for quality, cost effective, and compliant labeling systems.
When I first got started in the industry decades ago, function and compliance were pretty much the overriding features of many device labels. Much like the story of railroad tracks being almost the exact same width as Roman war chariot wheels, patient label sets are still almost all a half inch tall per unit. Why? Dot matrix printers printed 6 lines of info per inch and patient labels needed three lines. One of the first attempts of making a label for a medical device that actually had some decent graphics on it was the Medtronic Spectrax line of pacemakers circa 1980 or so. It was a stretch for we flexo printers because not only was the harvest / sunset motif printed in fairly complex (for the time) four color process, but it was also perforated and had pinfeed holes for the above mentioned dot matrix printers. Because of issues of that nature, getting input from your label supplier on what exactly can be achieved using the current technology is critical. A confession: At the time I may have not been the best guy to ask about color and marketing issues. In a meeting, a couple of the design / marketing types keep talking about the color teal. I will admit to having had no clue at that time as to what the hell color teal was and asked for help. When one of the incredulous designers said, “You don’t know what teal is?” I thought the question was posed in a bit too condescending of a manner and told him that I had harvested and eaten a number of blue wing and green wing teal ducks over the years and had to guess it was some sort of blue /green blend. This provoked a fairly even split of hilarity and incredulity among the meeting attendees, but it was actually kind of fun. I am still not the go-to guy by any means on that kind of thing, but we have the people on the aforementioned label team who are.
As brand identity becomes more sophisticated and important, is also has more and more of an impact of labeling, especially with real estate being at a premium. Corporate branding and thick guides that are published on correct and proper usage of logos on printed media are now the norm. ‘Making it pretty’ is not that simple even on food, hard goods, and consumer packaging but on terminally sterilized medical device packages it is significantly more complex. Sometimes I think it is instructive to think of certain processes backwards. When I teach rolling as a sea kayak instructor, I always begin with the position a person is in when they are coming out of the water and back to upright. It just seems to work better because if people know what it feels like to successfully complete the roll at the end, it becomes easier to visualize when going over into the water on the front end. With a device package, the “finish” is usually when the shelf carton hits the garbage in pre-op and the device gets dumped from the tray or pouch into the sterile field. A number of nurses panels have proven that the only thing the OR nurses really look at is whether it is indeed the correct device and that package integrity is maintained. Going back a step from that is the warehouse in the hospital that needs everything clearly marked and legible for storage. One more step back to hospital sourcing and we begin to find brand identity to differentiate between competing devices and put the device manufacturers expertise and reputation at the forefront. Going further back to stores or finished goods inventory at the med dev manufacturer and legibility and ease of picking product are important.
The other important item is when devices come back from the hospital for restock. A robust and well-designed tamper indicating label on the packages can save serious dollars by preventing unnecessary repackaging and resterlization costs. On the manufacturing floor, ease of adding variable data, be it via thermal transfer or laser printing, is very important for good throughput on the line. Which brings us to the genesis of the whole process, label design.
Design for a new device label should involve all the players from the design engineers, packaging engineers, marketing and branding, regulatory affairs, and (sometimes forgotten) the people who are actually going to have to execute the design, your friendly label printer. If we label printers actually have that 2” thick ‘corporate style guideline’ we can help to incorporate those guidelines into a functional package. If you want a good yet cynical overview of this process, read my Label Haiku blog post from about four years ago. Things have not changed much, but we have all learned how to operate and gain some elbow room in the haiku situation. Gordie Howe of the Detroit Red Wings would tell you he wasn’t mean or vindictive, he was just trying to create some room to operate efficiently. One of our more effective techniques to create room within corporate guidelines (other than elbows and butt ends) is the rapid prototyping process. With a combination of digital printing and magnetic die tooling, we can create samples of the label project on the exact material with the exact diecuts. This is both cost-effective and can compress the timeline of getting the finished product to market. Someone one told me those two things were fairly important, haha. Extended content labels can increase the amount of text and verbiage and create that needed extra space as well. Symbols, both EN 980 and ones created by the device manufacturer, can also be very useful for space conservation.
If the project managers, engineers, and marketing folks at the device manufacturers can put their heads together with the our AWT project managers, engineers, and prepress / press experts, the combination is pretty much as unstoppable as Gordie Howe planted in the crease in his prime. We have a process in place, a successful process over the years, and are ready to help create a cost-effective and timeline-friendly terminally sterilized device package.
