When designing a new medical device, you may work with the mindset of, “It’s what’s inside that counts.” Sure, the inner workings and technology are essential to the product’s functionality, but external factors are also important. That includes an often-overlooked feature of medical devices – labeling.
Creating medical device labeling is very different – and more challenging – than printing labels for other non-regulated products. However, it’s a critical step in getting your device to market and into the hands of your customers.
Considerations of medical device labeling
If you’re not sure where to start with medical device labeling – or want to make sure you’re on the right track – here’s our list of seven areas to consider.
- Patient safety information – A critical aspect of a medical device label is the information for patients. Sure, some of this information is mandated, but the primary purpose is to ensure the safety and well-being of the users. There’s specific information that needs to be included, and there are common mistakes to avoid. Also, keep in mind that by FDA and ISO standards, medical device labeling isn’t just the label that goes on the device. So, you may need to carefully develop the instructions for all literature, including instructions and packaging, and potentially in multiple languages.
- Regulatory compliance – The FDA has specific labeling requirements for medical devices. Adhering to these complex regulations requires collaboration between your designers and compliance team. To ease the burden and reduce the risk of non-compliance, consider working with a manufacturing partner with experience in this field who can navigate you through the complexities. Also, you can look into labeling solutions that are ready-made to meet stringent industry requirements.
- Material consideration – Selecting the optimal materials for your medical device label is vital for regulatory compliance and ensuring the label is tough enough for its intended environment. For example, if your device could be exposed to liquids, chemicals, or other harsh factors, you will want to consider durable label materials suitable for these conditions.
- Printing methods – The printing process and ink selection also play into regulatory compliance and durability. In addition, the method (and equipment used by your printing partner) can open the door for functional printing techniques, including the next two points.
- Traceability – Most medical devices and products require a unique device identification (UDI) for traceability and patient safety. You can enhance the traceability of your device with variable data printing or RFID inlays.
- Brand protection – Techniques can be applied to your medical device label to prevent tampering, counterfeiting, or other actions that hurt your brand’s reputation and bottom line.
- Sustainability – You can source sustainable materials to minimize the environmental impact of your product.
A top player in medical device labeling
As you can see, developing a medical device label is no simple task – which is why it’s wise to lean on the expertise of a manufacturing partner. At Tapecon, we have decades of experience working with medical device and pharmaceutical companies to create high-quality labels that meet regulatory standards. We’re also proud to be included on the shortlist of “key players in the global medical device labeling market” by Transparency Market Research – a recognition held by only a few US-based contract manufacturers. With our materials expertise and converting capabilities, we have everything you need to design and produce your medical device label.
Let’s make something great
With over 100 years of manufacturing experience, Tapecon works with product teams to solve challenges, create products, and enhance lives. Learn more about our labels and decals applications.
