Even though packaging for medical devices occurs when manufacturing is complete, planning for packaging must be applied at the very beginning of the product design and carried on throughout the development process. Human factors engineering (HFE), also known as usability engineering (UE), is an integral component of product design as it identifies human behavior, abilities, limitations, and other characteristics of medical device users that are utilized in the design. Those characteristics, among other considerations, are also important when considering packaging alternatives for medical devices.

Developing the foundation for how people interact with a proposed technology or device is a critical principle of HFE. While the focus of HFE may be more design-intense, it is also important to realize its impact on how a device should be packaged for both end-users and regulatory validation. Therefore, packaging must be a focus at the early stages of product design and considered throughout each phase of the development continuum.

Meeting Compliance Regulations

Regulatory requirements from agencies like the U.S. Food and Drug Administration (FDA) consider safe packaging and labeling as a significant part of the user interface for a device. Packaging and labeling go through a validation process, where safe and effective use must be demonstrated. This is why the usability of the packaging is a principal design consideration as well as why the proactive use of HFE principles ensures user acceptance and a successful compliance outcome.

The healthcare industry significantly emphasizes getting packaging and labeling factored in early in the medical device’s product development cycle to alleviate stress, minimize risk, and eliminate costly surprises. Packaging has substantial influence on user satisfaction but can also greatly contribute to user safety. The FDA isn’t concerned that a device manufacturer reaches its commercial objectives and marketing outcomes, but rather its focus is solely on risk management and eliminating any potential use errors that could result in harm during clinical care outcomes. Therefore, the objective of HFE is to harmonize both use safety and ease of use. If evaluated early in the development process, the result is a more optimal user experience and a positive clinical outcome for both the patient and clinician.

Ease of Use and Risk Management

Often, packaging and labeling are difficult to separate from each other since labeling is often seen as part of the packaging, and both are seen as medical device user interfaces. Typically, medical device packaging has incorporated critical labeling information as part of the package such as equipment labels, control labels, package labels, directions for use, or maintenance manuals. Additionally, electronic display panels are considered labeling if instructions, prompts, cautions, and parameter identification information are given to assist users with using the product as intended or as a use-related risk control measure.

With the application of HFE, it is important to note labeling is not the only impact on usability. The mechanical and industrial design of the packaging can cause tremendous impact on usability from both a risk management and ease of use perspective. For example, the packaging can cause a positive experience for intended access by using an intuitive sequence that is aligned with a purposeful workflow. The packaging can also accentuate labeling of particular criticality through physical arrangement of the device and associated labeling in the packaging.

Additionally, packaging and labeling design can positively direct users’ behavior toward the intended use or act as a use-related risk control measure (e.g., to remove surgical instruments from packaging in the purest way possible into the sterile field to minimize contamination or encourage a first-time user to read instructions). Deficiencies in packaging design can be a detriment, introducing potential use errors that may have a significant impact on risk management in relation to user safety.

Medical device manufacturers must also incorporate the design in their quality management system (QMS), which entails several elements relating to labeling to meet the Good Manufacturing Practice (GMP) requirements of quality system regulations. The quality of the packaging and labeling must be adequate to ensure labeling meets the GMP device master record requirements with respect to legibility, adhesion, and placement, as well as to ensure that manufacturing operations are controlled so the correct labeling is always issued and properly applied.

Medical Device Packaging Influences

There can be numerous scenarios that occur in the medical device space, which is why understanding and addressing how packaging can influence device preparation and deployment is so important. Medical device usage in a home care setting is growing exponentially due to such reasons as Baby Boomers aging, awareness, and acceptance among the population for more in-home devices. Packaging will become an even more integral part of the overall medical device design because it is seen as helping to ensure the safe and successful execution of care activities.

Usage scenarios regarding 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 in a very controlled clinical environment, like an operating room or an ICU.

HFE can help direct device packaging development processes beyond conducting usability after the design has been developed. For instance, when the HFE team analyzes the workflow for care delivery using task analysis, the user’s interaction with the packaging, including all of its layers (primary and secondary packaging), is one of the initial tasks in the analysis.

Task Analysis is Essential

HFE task analysis often reveals design packaging opportunities where workflow efficiency is enhanced by designing functionality that does more than simply protecting the device during shipping and storage. Medical device manufacturers use HFE task analysis to outline the device kit contents and its purpose as well as to deliver safer passage for the device from its packaging to the intended use and in the intended use environment: Transfer into the sterile field, sequential unpacking to prioritize the device kit contents intended order of use, etc. When the intended tasks, and use environment(s), are understood early in design and development, process enhancements to packaging and labeling can be incorporated to better support users with using designs as a manufacturer intends as well as other aspects like more efficient storage, including better access to, and retrieval of, the stored packaging.

Depending on feature complexity and functionality, the task analysis typically will not increase the reoccurring production cost of the packaging—rather, it will provide insights for better supporting the users. 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 stays the same.

Optimum Packaging Designs with HFE

Packaging design improves when deploying HFE principles early in the process, as it delves deeper beyond usability evaluations during product development cycles, ultimately delivers a better user experience, and ensures safe execution. Expect to see more packaging innovations in the future, such as 2D barcode with unique numbering/serialization, UV identification codes, holograms, or hidden text printed using security or magnetic ink to safeguard against product counterfeiting. As there continues to be momentum in developing more innovative and advanced technology devices for both the home and clinical environments, packaging will become more instrumental to enhance the user experience and help ensure user experiences result in positive clinical outcomes. 

Prioritizing packaging and sterilization at the onset of the design process facilitates commercialization and can accelerate time to market by providing a more comprehensive understanding of intended use and what use-related risks to control. Previously, packaging design and development would often occur during the last few stages of a medical device development process. By deploying HFE processes early, packaging options can be designed using the appropriate materials and user interfaces, which reduces timeline risks and cost surprises. In this competitive medical device development market, HFE can make a substantial difference in ensuring a smoother validation process and quicker time to market. 

Article Source：Medical Product Sourcing