Imagine for a moment that you’re a patient preparing to apply a new insulin monitor, but when you look at the label instructions, you see—
a blurry patch of black ink. How can the device be distributed safely when the diagrams are subpar?
Medical device labeling is essential to product identification, application, and branding. After 38 years of manufacturing medical devices, Strouse’s team has the experience to meet label quality requirements.
Whether you’re struggling with label quality or simply anticipating the process, read on to learn about printing standards in manufacturing, setting your expectations, and how to obtain quality labels.
We’ve divided medical device label printing into two distinct categories: product information and logos/pictograms.
Printed codes must be readable by machines and/or human eyes. General labeling information will include the business and all of the relevant manufacturing information. It will also include variable data, such as the date of manufacturing, expiration date, and lot information. This information is required to meet FDA labeling regulations. These are typically done in black and white, and the important part is that the information is clearly conveyed.
Conversely, logos and pictograms are more about creating a brand image and identifying your company correctly on your product. They tend to be more colorful, fanciful, and include a lot more detail.
Logos represent your brand. Shaded backgrounds may require flood coating, which a reliable manufacturer can easily handle.
Pictograms are instructional diagrams that show the user what to do, including product application instructions (such as “Place on arm” or “Peel layers 1, then 2”).
Medical device labels possess different quality expectations depending on the label’s purpose.
For example, most labels only require standard legibility to be considered acceptable. Standard legibility is exemplified by “crisp” images that are legible without speckles, bleed, shadowing/ghosting, or smears.
Standard-level printing is slightly below retail packaging standards, which may involve photo-level realism. However, the text must still be readable, and data codes must be functional.
“[You should] expect text to be legible and logos to be reasonably crisp and discernible. Whether it’s a logo or a manufacturing date, it is important to your company’s reputation that the printing accurately represents your branding.” —Denny Tichnell, Quality Manager at Strouse
Note that your printing expectations will be higher if your print is a point of sale for customer-facing retail labels.
Certain medical labels must be manufactured in a Clean Room for patient safety. Clean rooms help minimize the risk of foreign particles, but they are not necessary for every product.
One of the things you might be asking yourself is, “What do I need to do to achieve a high print quality without driving up my price?” The answer is a combination of several factors that all work together.
Choosing the correct ink and substrate is one of the most critical factors in printing. You want to ensure that the ink you select sticks to the material you’re printing on without smearing or flaking off.
Auditing your materials allows you to test whether the ink can rub, scratch, or peel off. When in doubt, ask your manufacturing partner to check whether the ink and substrate are compatible.
A dyne level is the measurement for a material’s surface energy. In the case of label printing, the dyne level is used to represent how well ink adheres to the substrate. If the ink beads up, your surface energy is low; therefore, you may want to reconsider your choice of ink or materials.
An effective printing substrate’s dyne level will generally be around 42 dynes/cm or higher, although we have also seen acceptable materials at around 38 or so. If the dyne level is too low, the ink will not adhere to the material. Conversely, if the dyne level goes up dramatically, the ink will not wet out as it should. If your material’s dyne level is fluctuating, this can create a lot of additional cost and quality issues that have to be addressed.
If your text is extremely small, it can be challenging to print clearly. Flexographic printing, for instance, uses a soft rubber print plate that risks deforming tiny characters when pressed against the substrate, making trademark symbols like ® or ™ and subscripts harder to print with less white space.
Your technical design tolerances drive the tooling price and complexity. Designs with fewer accuracy requirements are manufactured using less costly printing tools, whereas designs needing tighter tolerances and better-controlled repeats require more expensive tools.
Designs with fewer colors are easier to manufacture and can significantly reduce printing costs.
A trustworthy partner will meet your medical label’s aesthetic and functionality requirements.
If you’re ready to discuss your design, contact us for a quote today. Our team will work with you to devise the most efficient labeling solution.
Reach out to get started, or you can learn more about Strouse’s printing capabilities.