During the development cycle of a medical device, it’s easy to think about packaging last.
After all, packaging isn’t a functional part of the device. It’s the last process you’ll apply to your product before it’s ready for market, and it’s just going to get thrown away in the end anyhow. There are so many other concerns that need to be addressed before product development can progress.
But delaying this crucial step can be a serious and costly mistake. Here’s why, and what you need to keep in mind during the medical device packaging design process.
For many manufacturers, there’s only one reason they need to care about medical device packaging: they need to pay attention to packaging design in order to remain compliant. The Food and Drug Administration (FDA) requires medical device packaging to be sterile, resilient and labeled in a specific way to enable tracking.
But staying in compliance with the FDA isn’t the only reason to focus on medical device packaging, or even the biggest reason. The most important? Ensuring your device arrives intact and sound after shipping.
If you find a defect in a non-medical device or if the product breaks sooner than expected due to rough shipping and handling, you can simply return it and get a refund. Medical devices can’t always be returned, and when they can, they are returned at the cost of those devices’ use. Patients depend on medical devices for crucial, sometimes life-saving functionality; if a hospital receives a shipment of defective equipment, that’s equipment that can’t be used to keep a patient healthy.
It’s important to recognize, too, that damaged medical devices don’t always show visible defects. They could be in full use or even implanted in a patient when they fail.
Thus, quality packaging is about far more than just meeting the regulatory compliance required to bring a product to market — it’s about:
To the fullest possible extent, packaging design should be included in the product design phase. Ideally, OEMs will be able to use a similar device or a prototype to test the initial packaging design, take note of any problem areas and continue to work on these issues as design and development moves forward.
As the device evolves throughout development, it’s crucial that designers take note and consider whether these modifications will affect the packaging. Every element of a medical device is going to impact its packaging. Its weight, material, texture, accessories, shape — these characteristics interact with the packaging, sometimes breaking sterile barriers, overwhelming retaining elements and so on. Intermittently testing the medical device packaging after major design changes is an excellent way to prevent any last-minute headaches.
Once the product is complete, the designer will need to spend some time refining the packaging one last time. If packaging design has been a consistent element of the product development process up until this point, this final stage shouldn’t take too long. Soon, your product will be ready for market.
It’s impossible to know the exact environment that your device is going to be exposed to during shipping. Repeatedly running your packaging through a battery of tests is critical to ensuring that it functions correctly. These include:
The exact nature of the tests you perform will depend on both the final product and packaging design. Thus, building an understanding of your packaging needs early on in the process can help reduce testing lead times.
If you’re uncertain about what tests your device needs, or just want to gain a clearer understanding of the testing process in general, you can review the ISO standard 11607. This standard discusses the requirements and test methods for materials, sterile barriers and general packaging systems.
Regardless of whether an OEM conducts manufacturing in-house or with a contract manufacturer, the design of the product’s packaging will need to come from the OEM.
Beyond that, the medical device packaging process depends on the relationship between the contractor and the OEM. Some OEMs prefer to perform the final packaging process in-house, while others have their contract manufacturer handle all packaging. Depending on the specific manufacturer’s capabilities, they may handle the packaging themselves or contact a member of their network that specializes in medical device packaging.
As in all aspects of medical device manufacturing, make sure you have a good relationship with your contract manufacturer when relying on them for medical device packaging services. As we’ve covered, this stage of the medical device development lifecycle is crucial, yet often overlooked. It’s important to have trust in your contract manufacturer’s capabilities when handing off packaging responsibilities.
This should serve as a primer to the medical device packaging process, but there’s always more to learn. If you’d like to discuss your packaging process, get in touch with one of our experts.
