As new medical devices are introduced to the market in ever-increasing numbers, it becomes increasingly critical for clients to have effective, and 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 manufacturer’s brand identity becomes more difficult and challenging. This is 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-effectiveness, and compliant labeling systems.

Functionality and Compliance

Years ago, functionality and compliance were the main 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 information per inch and patient labels required three lines. One of the first attempts at making a label for a medical device that actually had intricate graphics was the Medtronic Spectrax line of pacemakers circa 1980. It was a considerable challenge for flexographic printers because not only was the harvest/sunset motif printed in a 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 this, getting input from label suppliers on what exactly can be achieved using the current technology is critical.  

Make It Pretty

As brand identity becomes more sophisticated and important, it also has more of an impact on labeling – particularly when real estate is at a premium. Detailed corporate branding standards 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. With a device package, the “finish” is usually when the shelf carton lands in the garbage in pre-op and the device is discarded from the tray or pouch into the sterile field. Several nurses’ panels have proven that many operating room nurses only look at whether they have the correct device and that the package integrity is maintained. If we take a step back, hospital warehouses first need everything clearly marked and legible for storage. If we look a further step back and consider hospital sourcing, we’ll see how brand identity is integral to differentiate between competing devices, and how putting the device manufacturers’ expertise and reputation is at the forefront. Legibility and ease of picking a product are paramount as well. 

Another important consideration is when devices come back from hospitals for restocking.  A robust and well-designed tamper indicating label on a package can save money 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.

A Team Approach

Design for a new device label should involve the design engineers, packaging engineers, marketing and branding, regulatory affairs, and the (sometimes forgotten) people who actually execute the design – the label printer. If label printers have access to a complete corporate style guideline, they can help to incorporate those guidelines into a functional package. One effective technique to create room within corporate guidelines 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. 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.

When project managers, engineers, and marketers at the device manufacturing company work together with our AWT experts, the outcome is ideal. We have ]a successful, proven process, and we are ready to help create a cost-effective and timeline-sensitive terminally sterilized device package.

AWT labels & Packaging
Attn: Blake Insteness
binsteness@awtlabelpack.com
(612) 706-3775