Company insight
Is your die-cut lid right for your device?
As medical devices become more sophisticated and valuable, packaging decisions are becoming increasingly nuanced. Medical Device Developments speaks with Charlotte Mavor, senior product portfolio manager at Oliver Healthcare, about how manufacturers can evaluate die-cut lid solutions and why there is no one-size-fits-all approach.
What are the most important factors when choosing a packaging solution and has that changed? Charlotte Mavor: Honestly, the fundamentals haven’t changed much; ISO 11607 still sets the bar. The packaging must protect the device, keep the sterile barrier intact through sterilisation, storage and distribution, and allow aseptic presentation when it is opened at the point of use. What has changed is the complexity surrounding those requirements. Medical devices are becoming more sophisticated and often higher-value, and there is far more focus on sustainability and usability than there was ten years ago. As a result, manufacturers are increasingly viewing packaging as part of the overall device system and user experience, rather than just the thing that keeps the device sterile.
How does this relate to die-cut lids? A die-cut lid can’t be thought of in isolation. What matters is the interaction between the lid, tray and device as a complete system. Manufacturers need to understand how materials seal together, how they perform through sterilisation and transportation, and how the package opens and presents in a clinical environment. Successful packaging designs consider the entire journey from the production line to point of care.
, one of the key choices is how the coating is applied: fully coated or zone coated. A fully coated lid has an adhesive coating across the whole web and is a proven versatile solution for many medical device applications. With a zone-coated lid, the coating is applied only where it is required for sealing, while other areas remain uncoated. This can be beneficial when the device or package
Can you talk us through the different types of die-cut lids? Die-cut lids vary in material, shape and how they seal. For coated lids, particularly porous materials like medical-grade paper and Tyvek®
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With a zone-coated lid, the coating is applied only where it is required for sealing.
design creates a reason to minimise potential interaction between the device and the coating. It can help with sterilisation too. Coating less of the lid means you keep more of that porous surface open, which can improve breathability. Depending on the package design and validated cycle, this can support gas exchange and degassing during EO sterilisation.
Are there applications where zone-coated lids are valuable? It is often less about the device category and more about the specifics of the application. Larger or heavier devices, products with complex geometries or packaging configurations where the device can move during transit are all worth a closer look. Breast implants are a good example. Because of the implant material, if it touches the lid during sterilisation or distribution, there is a risk it could interact with the coating. By applying coating only in the seal area, the part of the lid sitting over the implant stays uncoated, which reduces the chance of the device sticking to it.
What are common misconceptions surrounding lid selection? One common misconception is that more coating automatically means a better package or a stronger seal. Seal performance depends on using the right coating in the right location and validating it
against the specific tray design and manufacturing process.
Another is that zone-coated lids are superior. Neither option is inherently better. The right solution depends on the application, the packaging system and risks that you are trying to manage. People also sometimes assume a lid always needs to be porous. That is essential for gaseous sterilisation, but devices sterilised by gamma or e-beam may not need a breathable lid, and moisture-sensitive products may actually need the barrier of a foil or film lid with a peelable sealant.
What advice would you give for developing packaging for sensitive or high-value devices?
Start with the device and the risks rather than a material specification. The most effective approach is to think about everything the pack goes through and evaluate the lid, tray and device as an integrated system. Then choose the solution that best fits the application. Especially for sensitive or high-value devices, involving packaging experts early can help identify potential risks before the packaging configuration becomes fixed. Throughout the process, the question I always come back to is: what problem are we really trying to solve? ●
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