Improve medical device safety with these packaging design tips

June 2, 2021

Packaging is often one of the last pieces to come together in R&D activities, yet it is often the first experience users have with a new product. The design of a product’s packaging can set the tone for the entire user experience.

Within the medical device space, considering the human factors requirements with respect to packaging earlier in the design process has been shown to help improve the safety and effectiveness of device use. Furthermore, recent updates to medical device guidance from the EU and China have suggested that agencies are placing a stronger emphasis on well-designed packaging ahead of regulatory submissions.

Whether the packaging is a simple envelope or multi-step unboxing with several layers of instructions, there are a multitude of areas to consider to ensure the packaging experience is straightforward and effective for users.

1. Identify & balance needs of multiple end user groups

First and foremost, it is critical to define the users who will be interacting with the packaging and understand their specific needs. Often with medical devices, there will be multiple end user groups, such as health care providers (HCPs), patients, and caregivers, who interact with the same device. When designing the packaging, it is important to differentiate how the experiences of the different end users will overlap and/or work together. For example, will the medical device be shipped with both patient-facing materials and HCP / trainer-facing materials within the same packaging? Or will these be shipped separately? If shipped together, is it clear who is the intended audience for each part of the packaging?

It is also important to understand the previous experience, training, and ability of end users so the packaging and relevant labeling can support the appropriate mental models of the users.

2. Understand context of use: sterilization, transportation, re-packaging, and storage needs

Depending on the use environment, the packaging may serve different needs for the end users. For example, HCPs working in sterile conditions may have several layers of packaging to help maintain sterility of a device prior to a surgery. It is common to have both “inner” (i.e., sterile) and “outer” (i.e., non-sterile) packaging in these instances. The packaging must also clearly label the sterilization needs and how to inspect the integrity of the package to verify it has not been tampered with.

Other devices where sterility is less of a concern, may be packaged and repackaged several times, or even transported in between use via the packaging components. For example, if a patient is prescribed an insulin pump by their HCP, they may take the device home in the packaging after receiving training. In this case, well-designed packaging would need to be able to be repackaged easily and protect the device during transportation from the healthcare clinic to the patient’s home.

It is important to consider where and how the product will be stored as the storage environment can also have implications for the packaging footprint and materials composition. For example, space requirements may differ if the package is typically stored on a crash cart vs. a refrigerator vs. a pharmacy shelf. Packaging stored in a refrigerator may need to withstand very cold temperatures and/or condensation upon warming without degrading the materials vs. other storage locations.

3. Guide the experience through labeling & physical components

Packaging has the unique opportunity to help support and reinforce training and design mitigation controls for safe and effective use by guiding users through the correct use steps. For example:

  • A medical device with multiple parts that needs to be assembled in a particular order, could incorporate labels and individually packaged components to help instruct the users on the proper order for assembly (e.g., step 1: open part TRADENAME).
  • Clear plastic screen overlays can also be used as a first introduction to an interface, providing helpful tips, such as “press button to turn on!”) prior to being discarded.
  • Packaging can also be used to protect users, such as to provide warnings (e.g., “STOP! Read instructions prior to opening”) and as physical blockades intended to prevent hazardous use (e.g., additional packaging to help prevent needle stick prevention).
  • Labeling on cartons can be a prime location to communicate storage requirements, customer support information, or other critical information that users might need to reference.
  • Quick reference guides printed on cartons, as well as dosing or titration calendars are also examples of materials that could be leveraged through packaging to help reinforce proper use.

4. Differentiate similar packaging

Particularly when a medical device, medication, or combination product is similar to an existing item on the market, it is important to ensure that users can appropriately differentiate the relevant products for the type of drug, formulation strength, indication(s), and/or delivery mechanism (e.g., pre-filled syringe vs. autoinjector). Size, color-coding, and shape are all common ways to differentiate packaging designs. Clearly labeled packages with easily representative product imagery can also help reinforce product differentiation. In addition to the physical packaging, careful consideration should be given to the naming of products to prevent confusion between types of similar products.

5. Design packaging to be inclusive for all

Well-designed packaging follows best practices for universal design, where the design is inclusive of the needs of users with varying levels of vision, dexterity, and/or cognitive abilities. For example, a medication carton may be designed so that it could be opened with one hand without the contents spilling, which is particularly important for users who have arthritis, neuropathy, or other dexterity limitations. In a pharmaceutical setting, where differentiation of packaging is of critical importance, packaging should be assessed for contrast for those with color and low vision needs so that they are still able to successfully identity and differentiate the package from other available options. It is also recommended to use large, high-contrast fonts and symbols, and terms that are deemed common and easy to understand for the end user group(s).

These are a few high-level areas to explore when designing appropriate medical device packaging, many of which can be applied beyond the medical space. Depending on the specific needs of your users and your product, there may be other areas to explore, such as cultural differences for products with multi-country launches, translation and labeling needs, and other items related to use-related risk. Regardless of the specific needs, it is recommended to start these conversations early in the design process to help think about how that first user experience unboxing the device can be a positive one.