Building a Better Medical Device Overlay

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Building a Better Medical Device Overlay


The process of manufacturing medical devices is complex and intricate. With so many details to consider, the product overlay, or label, is often an afterthought. However, it’s critical not to neglect them. They influence the user’s ability to access all the product features and affect the equipment’s functionality. Here are some factors to analyze if you want to create better labels for medical devices.


Information Requirements

As you design your overlay, consider what information needs to appear on it. Will you need to include barcodes, QR codes or serial numbers? Will the equipment label require a unique device identifier for the FDA GUDID? Will you include instructions in tiny print? If your overlay needs such information, the substrate and printing process you choose can affect its quality and readability.

For small print, consider metal photo printing or digital printing. For variable data such as barcodes, your best printing methods are:

  • Metal photo developing
  • Hot stamping
  • Laser etching
  • Digital printing


Overlay Material

Depending on your device, the substrate, or material, on which your label is printed should be taken into account. A cost-effective, durable choice is vinyl. It is also easy to clean. Lexan, a polycarbonate material, is quite versatile for labels. It is durable and affordable, and it’s easy to emboss. Lexan is considered a go-to material for device overlays. If your equipment produces a lot of heat, though, Lexan is not the ideal choice. Mylar or another polyester can withstand extreme heat.

The substrate finish can affect your label’s readability and functionality. A glossy finish attracts attention but isn’t the best choice if your device gets bumped and scratched. A more matte finish hides daily wear and tear while enhancing readability.


Expected Device Usage

Medical equipment endures a lot of hard wear, even though it is typically used and stored in a climate-controlled environment. Cleaning chemicals can cause adhesive to loosen and print to wear off. Field devices, such as those used in ambulances, are subject to additional wear. If the device’s overlay is replaced during maintenance, you may be able to use something less durable, but if the label needs to last the lifespan of the equipment, you may need to invest in something sturdier.


The Effect of Color on Readability

Your overlay’s primary job is to give information, so legibility is a requirement. Three factors will affect your label’s readability:

  • Font size
  • Color
  • Contrast

The larger you can make your font, the easier the label is to read. The same is true for a high-contrast overlay — the more contrast between the words and background, the better.

A yellow background with black type is an excellent high-contrast combination, as is black on a white background. Reversing these combinations — using yellow or white type on a black background  — also works well. If you prefer to use blue, it contrasts nicely with white.

Red can be used to draw attention to critical information. As for QR codes and barcodes, they scan most efficiently if they are black on a white background.


Information Positioning

Your most crucial label information should be the easiest to find and read. Use large print, put it at the top or make it stand out with color. The fine print can go near the bottom or wherever it fits best, allowing the primary information to stand out.

Your overlay is also an important branding tool. Users want to know the company name and contact information if they have questions about the device or need to order replacement units or parts. You can consider adding a QR code that users can scan to find your contact information. A phone number is essential, as they may want to speak to someone about the device.

The overlay on a piece of medical equipment plays a prominent role in its use. It is often the first information a health care provider has about the device. A well-designed label helps people use the equipment to its maximum capacity and serve patients well.

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