Packaging Design Considerations to Ensure a Safe, Sterile Medical Device

Choosing the right packaging configuration for a medical device is critical to ensure safety and sterility to the end user. With so many competing priorities and elements to consider when getting a medical device ready to hit the market, even a significant factor like packaging could fall under the radar. Patient protection, device sterility, clear instructions, and hygienic presentation all play important roles in ensuring quality packaging and a successful and functioning medical device.

In some cases, companies opt for standard offerings, but this can be limiting. Tailoring the packaging to the device ensures it is working for the product—not the other way around.

To ensure manufacturers pass their packaging evaluation and end users receive a fully functioning, sterile, and presentable device, companies must understand potential risks and prioritize packaging design early in the device development process.

Avoiding Compromised Sterilization
Ensuring a medical device remains sterile until the end user needs it is imperative to patient safety and overall user satisfaction. Device packaging serves as an important barrier against unwanted exposure to bacteria and other potential contaminants. If the packaging design falters and allows a seal to break, the sterile barrier is compromised and the device is not useable. This mishap puts patients at risk and leads to the waste of what would have been a perfectly functioning product.

Identifying risks that could lead to a compromised sterile barrier is something a testing partner can help with—however, there are factors to watch out for when designing packaging. Certain elements in packaging, such as any folds or channels in a heat-sealed poly packaging pouch, could lead to exposure and jeopardize the sterile barrier. Additionally, heavy or unnecessary packaging may lead to tears or dents in the material, causing issues with the integrity of both the sterility of the package and the device. Manufacturers can minimize the likelihood of a broken sterile barrier by designing the packaging with these risks in mind.

For any sealed areas of the package system, a testing partner can confirm the accuracy of the manufacturer’s heat sealer using a bubble emission or a dye penetration test. These tests will detect if a package’s integrity is vulnerable. A testing partner can also put packaging through drop, compression, and vibration testing to assess whether the packaging configuration will negatively react to different distribution environments. Shipping and handling can be unpredictable, so it is crucial to ensure the packaging is up for the journey and will arrive to the end user fully intact with a functioning device inside.

Prioritizing Protection
To guarantee patient safety, make certain the packaging materials, enclosures, usability, and presentation are configured to the highest quality. The package design should strike a balance between providing adequate medical device protection with as few components as needed to conserve costs.

To safeguard the medical device’s integrity and sterility, a well-versed testing partner with experts in packaging can help manufacturers determine an ideal packaging configuration by leveraging their vast exposure and historical expertise. While a standard, single-package configuration across multiple products might be appealing to streamline the decision and implementation processes, selecting the correct amount of packaging a device requires is essential to establish packaging quality. This is typically not a one-size-fits-all situation.

Involving a testing partner will help manufacturers determine a reliable packaging strategy and save time. If the initial test results are less than ideal, testing partners can share their perspective on which factors to consider adjusting and provide support moving forward.

The Role of Aesthetics
In addition to ensuring optimal packaging performance, manufacturers also need to consider the experience component of delivering a device. The overall look of the packaging might not be as high of a priority as efficacy and safety, but visuals of a product can be just as important to the end user when selecting a product.

Over the counter or in the operating room, aesthetics still play an essential role in medical device packaging. Sizing accurately can avoid crinkled or tattered packaging that, while technically sterile, look dingy and unappealing.

Apart from the risk of a dented package deterring an end user, labeling also must be intact and clear for patient safety. Regulations set by the U.S. Food and Drug Administration (FDA) state that “all labels must be designed and applied to devices and containers so that the labels will remain in place and legible during the customary conditions of distribution, storage, and use.”

Damage-prone material might not only result in poor user experience, but could also impact medical device usability. To confirm a device meets these expectations, a testing partner may also use simulated distribution to help manufacturers predict whether the label would rub off, become illegible, or move out of place under normal handling conditions.

When designed strategically, manufacturers can guarantee safety for both the device and the patient. Fortunately, they don’t have to face this challenge alone. Medical device testing partners can guide manufacturers in choosing the proper packaging configuration for their device based on the product’s nature, planned sterilization methods, and intended use. Whether a company intends to use a standard configuration or take their own approach, taking the many factors at play in designing and testing packaging into consideration is critical to delivering a safe and successful medical device. 

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Britt Jones is the manager of package testing services for devices, biologics, and combination products at WuXi AppTec Medical Device Testing. He serves on the ASTM Committee on Packaging (ASTM D-10) and is a member of and certified by the International Safe Transit Association (ISTA) and the Institute of Packaging Professionals (IoPP). He can be reached at [email protected].