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Packaging for Clinical Trials

With different users, logistics, regulations, and volumes, designing packaging for clinical trials brings its own challenges. Be sure to consider the following in your design phase.

Caution labels are critical before the device is cleared by the FDA.
Caution labels are critical before the device is cleared by the FDA.

Unlike commercial packaging, clinical trial packaging will never hit the shelves of retail stores. This packaging is for research purposes only, so aesthetics take a slight backseat to functionality and usability, which are of primary importance. In some cases, graphics might even be completely omitted as in the instance of a blind study where anonymity is critical to the success of the test. This also means that the purpose and target users of the packaging, regulatory requirements, packaging logistics and storage considerations might be different than those for the eventual commercialized product. Once that has been established, designers are able to focus accordingly and create concepts that fit the needs of the product. The process is generally a lot quicker than for commercialization packaging as it usually requires a lot fewer iterations and presentations between designer and client–it will not be market-facing and therefore can have a simpler aesthetic. One important thing to note during this process is the assembly of the device into the chosen packaging solution. For example, if the device is required to be assembled in a clean room, then fibrous materials such as cardboard cannot be used as any of the primary packaging materials for the product.  

Bio-compatible materials

When deciding on materials for packaging, in some cases, you might have to use biocompatible materials to be eligible for specific approvals and submissions. These include everything from the primary packaging materials to any adhesives or glues. Your suppliers will be required to provide the appropriate data sheets that certify biocompatibility; having these documents ready ahead of time is important for any regulatory submissions and approvals such as when seeking Institutional Review Board (IRB) clinical trial approval.

Labeling

Labeling is very important in packaging. Designers of packaging must collaborate with regulatory personnel and engineers on their team to gather a requirements list of symbols and text necessary for all of the device labeling. For example, if the device must be disposed of after each use, then the appropriate “single use” symbol must be visible on the packaging. However before the device is FDA cleared, it is critical that it bears the most important label: “CAUTION-Investigational Device. Limited by Federal (or United States) Law to Investigational Use.” (See accompanying image for an example.)  

Without this label the device can be easily mistaken for an FDA-cleared commercial device and therefore would not be allowed for any trial use. This would likely not pass any IRB approval process. Devices for clinical trials are strictly for research purposes only and are required to have that label. It must be affixed on the device in a manner that is clearly visible to the trial users.

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New e-book on Flexible Packaging