Packaging usability describes the extent to which a package can be used by the intended users in the intended context of use safely, effectively, and efficiently to identify, open, provide, and, where applicable, aseptically present a medical device. It considers not only the protective function of the packaging but the entire interaction between user and packaging system.
Why packaging usability matters
With many medical devices, the user's first interaction is not with the product itself but with its packaging. Difficulties in opening, interpreting, or removing can impair safe use and lead to use errors. Packaging thus influences not only logistics and product protection but also the usability and safety of a medical device, especially under demanding clinical conditions such as time pressure, sterile gloves, limited visibility, high cognitive load, or emergency situations. Under these conditions, even small weaknesses in the packaging design can have considerable effects on the safe provision of the product.
Packaging usability as part of the user interface
According to IEC 62366-1, the user interface comprises all elements through which users interact with the medical device. This includes not only displays or controls but also the accompanying documentation such as labeling and instructions for use, as well as the packaging that users handle when opening and removing the product. From a human factors perspective, user interaction does not end at the packaging: It often forms the first step in the entire use path of a medical device.
Typical usability problems with packaging
The most common challenges include hard-to-recognize opening points, unclear opening directions, high or inconsistent peel forces, unfavorable product orientations, hard-to-read labeling, risk of confusing similar variants, and insufficient support for aseptic presentation. Such problems often lead users to develop workarounds or to use packaging differently than intended. From a human factors perspective, such behaviors are usually indications of design deficiencies, not primarily of user misbehavior.
Connection to use-related risks
Not every packaging weakness is an immediate risk. Packaging problems usually become critical only in the concrete interaction with the user. This can give rise to use-related risks: contamination of sterile products, damage to the product during opening, incorrect removal, incorrect orientation, mix-ups, delays in the clinical workflow, or increased cognitive load. Packaging usability is therefore closely linked to risk management and to the use-related risk analysis.
Regulatory requirements
ISO 11607-1 requires a documented assessment of the ability of users to recognize the opening point, open the packaging correctly, and present the product aseptically. At the same time, IEC 62366-1 requires the identification of safety-related characteristics of the user interface as well as potential use errors. Interactions with packaging elements can fall under this, provided they influence safe use.
Consideration in the usability engineering process
Packaging usability should be integrated early into the development process: The use specification clarifies which users open the packaging in which context of use; the context analysis, which environmental conditions and stresses are present; the task analysis, which steps are required for safe provision; the use-related risk analysis, which packaging interactions can lead to hazardous situations. Formative evaluations identify design weaknesses early, while the summative evaluation provides objective evidence that the packaging interaction can be carried out safely. Typical evaluation questions are: Is the opening point recognized intuitively? Can the packaging be opened safely with gloved hands? Does the product remain correctly oriented? Does the packaging support aseptic presentation?
Packaging usability forms the interface between packaging engineering, human factors engineering, risk management, and regulatory affairs. With many medical devices, the packaging is the first, not the last, point of contact with the user.
Workarounds during opening are usually an indication of design deficiencies, not a matter of individual user behavior.
Frequently asked questions (FAQ)
Is packaging usability the same as sterile barrier testing according to ISO 11607?
No, but they overlap. Sterile barrier testing ensures technical integrity; packaging usability additionally considers whether users can actually open the packaging safely and provide the product as intended. A technically flawless sterile barrier system can still fail because of poor packaging usability.
Why do workarounds arise when opening packaging?
Usually as a reaction to design weaknesses such as hard-to-recognize opening points or excessive peel forces. From a human factors perspective, such workarounds are a reliable indication of design problems, not of individual user misbehavior.
When should packaging usability be evaluated in the development process?
As early as possible, starting with the first packaging concepts in the formative evaluation, not shortly before market release. Changes to the packaging design are much easier to implement early in the process than after technical verification has been completed.
Do you want to know whether your packaging can really be opened safely and intuitively in everyday clinical practice? We evaluate packaging usability as part of the entire user interface.
More about our usability engineeringSources
- IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
- ISO 11607-1:2019, Packaging for terminally sterilized medical devices, Part 1: Requirements for materials, sterile barrier systems and packaging systems