The Importance of Medical Device Packaging

Face Shield Cleanroom
November 5, 2021

Traditionally, packaging is the last thought in a medical device’s development process. Packaging engineers focus on the actual design and functionality of the device itself before thinking about the packaging.

Rightfully so, as the device itself is going to be used on a patient, so it needs to function as intended. However, packaging should not be overlooked. Instead, it should be considered at every stage in the development process of the medical device.


Medical Device Protection


Packaging for medical devices does a lot of heavy lifting to support the product. One of its most important functions is it acts as protection for the device from physical damage and biological contamination, in addition to other external factors that could sacrifice the integrity and sterility of the device.


FDA Compliance


Keeping devices protected is not the only function of the packaging. Device companies need to meet certain regulatory requirements that are laid out by the Food and Drug Administration (FDA). Packaging falls under these requirements as well. Staying compliant with the FDA requires specific sterilization methods, packaging materials, labeling, and traceability.

Medical Device Labelling


Labeling is another important aspect of medical device packaging. Not only is it important for displaying device specifications for consumers, but it’s another area of the medical device that falls under FDA requirements.

The FDA specifies that:

Any word, statement, or other information appearing on the immediate container must also appear ‘on the outside container or wrapper, if any there be, or the retail package of such article, or is easily legible through the outside container of wrapper.

Thus, packaging plays an important role for label display to ensure medical device compliance. 

Medical Device Cost


Finally, the design and materials used in medical device packaging can also greatly affect the cost of the device.

The cost of the packaging can be greatly affected by the materials used. For instance, packaging can be manufactured from any of the following materials whose cost all vary:

  • PETG
  • PP
  • PC
  • HDPE
  • HIPS

Selecting the right material is critical not only to ensure that packaging stays under budget constraints but also to meet regulations and performance requirements.


Packaging considerations should be top of mind during the medical device development process. While device engineers may not have the time to think about packaging, we do. Our in-house team of designers specialize in designing simple and complex medical device trays for any application. Not only can we handle the manufacturing of your device packaging, but our team also offers part design, process design, tooling, and quality planning.

Need help with your medical device packaging? Contact us today for support from a team of unparalleled packaging experts.


1 Comment

  1. Victoria Addington

    I’m delighted you mentioned that protecting the device from physical harm and biological contamination is one of the most crucial roles that medical device packaging plays. I had no idea that so many factors would be taken into account when packing medical devices. Considering this would be essential because it cannot be viewed as a last-minute fix and must be strong and sturdy to protect its contents. Businesses would benefit from investing in strong packaging for something as essential as this.


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