Human Factors Engineering (HFE), also referred to as Usability Engineering (UE), is the application of knowledge about human behavior, abilities, limitations and other characteristics of medical device users that are applied to the design of medical devices. These characteristics include mechanical and software-driven user interfaces, systems, tasks, instructional documentation, packaging, labeling and user training, all of which enable and demonstrate safe and effective use.
HFE is an integral component of the product-design initiative and thus should be integrated early on and throughout the entire development process. Creating the basis for how users interact with a proposed technology or device is the foundational principle. But, while the early focus of HFE may be more product design-intense, it is also a critical component in determining how that device will be packaged safely and efficiently for all targeted end-users and validated by regulatory authorities.
Packaging and Labeling Are a Regulatory Focus
From the regulatory perspective, packaging and labeling are considered a significant part of the user interface that ultimately must be validated to demonstrate safe and effective use. Therefore, the usability of the packaging has to be a primary design consideration. The proactive use of HFE principles can help ensure user acceptance and successful validation.
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In the healthcare context, device packaging and labeling have a great deal more impact than in other industries, such as consumer products. Indeed, medical device packaging can greatly influence user satisfaction, but it also has a significant effect on user safety.
Keep in mind that regulators, especially the FDA, are not concerned with the commercial objectives that influence marketing outcomes. The FDA is entirely concerned with risk management of potential use errors resulting in harm and poor clinical care outcomes. Ideally, the overall HFE objective is to harmonize safe use and ease of use, which results in an optimal user experience and a positive clinical outcome for both the patient and the clinician.
Usability and Risk Management
Since packaging and labeling are both considered medical device user interfaces, it is often difficult to separate them from each other, especially because the packaging is commonly the vehicle in which labeling is presented. Device packaging often presents critical labeling information for clinical usage, such as intended use, dosage, device size, expiration date and other critical user factors.
However, labeling is not the only component that impacts usability. The mechanical and industrial design of the packaging can have a profound effect on usability in regard to both risk management and ease of use. For example, packaging can enable intended access to individual components in a purposeful sequence that is aligned with a specific workflow. The packaging can also emphasize labeling of particular criticality by the physical arrangement of the device in the packaging and the corresponding labeling. It can also enable the sterile deployment of surgical instruments from the packaging into the sterile field to minimize contamination. Conversely, deficiencies in the packaging design can counter these positive HFE examples and introduce potential use errors that may have a significant impact on risk management in relation to user safety.
User Scenarios Vary Across the Continuum of Care
In the medical device space, understanding and addressing how packaging influences device preparation and deployment is an integral part of ensuring the safe and successful execution of a care activity. The usage scenarios, and therefore packaging requirements, vary greatly across the continuum of care. For example, there is a significant difference between a patient managing and operating a medical device themselves versus a trained clinician doing the same thing but in a very controlled clinical environment, such as an operating room or an ICU.
When the HFE team analyzes the workflow for care delivery, via a task analysis, the user’s interaction with the packaging, including all layers of it (i.e., the primary and secondary packaging) is often one of the initial tasks in the analysis.
Creating Positive Workflow Efficiencies with a Task Analysis
This HFE process can reveal packaging design opportunities that influence workflow efficiency by having additional functionality beyond just protecting the device during shipping and storage. Here are some packaging design examples that are the result of an HFE task analysis:
- Summarizes the purpose of the contents of a device kit
- Enables a safer device exchange from packaging into the sterile field
- Queues the contents in a device kit in the order of their use
- Provides a staging worksurface for device usage/deployment
- Provides a repository for collecting disposable parts, packaging bits and flushed fluids
- Enables better access to labeling, like a quick reference guide
- Enables more efficient storage and access to the stored packaging
Depending on the complexity of the additional features, the task analysis is likely not going to impact the reoccurring production cost of the packaging. For example, adding features to a thermoformed tray to organize and stage the contents may add design and testing time, but as long as the overall dimensions of the tray have not changed, the packaging production cost is the same.
By applying HFE principles early on, packaging design can evolve beyond usability evaluations in product development cycles to ultimately ensure a better user experience and safe execution. Furthermore, as more innovative and advanced technology devices are developed for both in-home and the clinical environment, packaging will continue to be more instrumental in the enhancement of the user experience helping to assure positive clinical outcomes.