In recent years, usability evaluations have been a significant step forward in assessing medical and pharmaceutical packaging. Unlike traditional packaging tests that focus primarily on material durability and ensuring the sterile barrier remains intact, usability evaluations are meant to get end user feedback on the packaging. The purpose is to ensure that packaging performs as intended in real-world use, not just under laboratory conditions.
For many pharmaceutical products, the intended user and use environment differ significantly from those associated with medical devices such as surgical implants or scalpels. Pharmaceuticals are often handled by patients themselves. This means people with varying levels of dexterity, strength, vision, and medical knowledge all need to be able to safely open and use these products. With the help of Johnny Kieu, Senior Packaging Engineer at PCL, we’ll break down what usability evaluations are, how they differ for pharmaceutical products, and why they are important.
What Does a Usability Evaluation Consist Of?
A usability evaluation assesses how effectively and safely a package can be used by its intended users in its intended environment. Rather than focusing solely on package integrity, the evaluation looks at the interaction between the user and the packaging system.
Typically, a usability evaluation is looking to define three things:
- Intended Use
- Intended End User
- Intended Use Environment
The goal is to identify potential use errors or design failures that could impact patient safety. Findings from usability evaluations can then be used to improve the package design before the product reaches the market.
How Are Usability Evaluations for Pharmaceuticals Different?
The most important difference in pharmaceutical usability evaluations is the intended user. For most medical devices, the intended user is typically a trained medical professional such as a surgical nurse, technician, or physician. These users are familiar with sterile techniques and medical terminology.
For pharmaceutical products, however, the intended user is often a member of the general population with no professional medical experience. This group may include:
- Elderly patients
- Individuals with limited dexterity or vision
- People managing chronic conditions
- Caregivers administering medication to others
Because of this, pharmaceutical packaging must accommodate a much broader range of abilities and expectations. A package that is difficult to open, confusing to use, or poorly labeled is a risk to the end user.
The Importance of Usability in Everyday Life
Many pharmaceutical products are part of a person’s daily routine. Whether it’s a blister pack, vial, prefilled syringe, or bottle with a child-resistant closure, ease of use is critical. Patients should be able to:
- Open the package without excessive force while being child safe
- Clearly understand dosage instructions
- Access the medication without damaging it
- Reseal or store the product safely if required
Clear labeling, intuitive design, and thoughtful packaging features help ensure that patients can safely and consistently access the treatments they need. Usability evaluations help validate that these expectations are met across a diverse user population.
From a patient perspective, good usability means confidence, independence, and better health outcomes. When packaging is easy to use and understand, patients are more likely to take medications correctly and consistently.
Key Takeaways
As pharmaceutical products continue to move beyond clinical settings and into patients’ homes, usability evaluations are becoming increasingly important. By focusing on real users and real-world scenarios, manufacturers can design packaging that not only protects the product, but also supports safe and effective use. With a growing emphasis on human factors in standards like ISO 11607, usability evaluations are no longer something that can be overlooked, they are an essential part of the pharmaceutical packaging design validation process.
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