Human factors engineering (HFE) determines human behavior, abilities, limitations and other characteristics of medical device users and is utilized in the design of medical devices. It involves mechanical and software-driven user interfaces (UI), systems, tasks, instructional documentation, packaging, labeling and user training.
The movement to develop more innovative and advanced devices for in-home and the clinical environment makes device packaging more instrumental in improving the user experience and clinical outcomes. And you can expect more packaging innovations in the future, such as 2-D barcodes with unique numbering/serialization, UV identification codes, holograms and hidden text printed using security or magnetic ink to safeguard against counterfeiting.
While the early focus of HFE tends to be more product-design-intense, it also defines how the device can be packaged safely and efficiently for end-users and validation by regulatory authorities.
Regulatory packaging and labeling compliance
Requirements from agencies like the FDA consider safe packaging and labeling a significant part of the user interface. Regulators require a validation process demonstrating safe and effective use. Thus, the packaging is a principal design consideration, and HFE principles ensure user acceptance and successful validation.
Medical device packaging influences user satisfaction and significantly impacts user safety. HFE harmonizes ease of use and safety for an optimal user experience and a positive clinical outcome for both the patient and the clinician.
Usability and risk management
Packaging and labeling are difficult to separate since labeling is often seen as part of the packaging, and both are medical device user interfaces. Typically, medical device packaging incorporates labeling information as part of the package, such as equipment, control, directions for use and maintenance manuals. The displays on CRTs and other electronic display panels are also considered labeling if they provide instructions, prompts, cautions or parameter identification information.
In applying HFE, the mechanical and industrial design of the packaging can have a tremendous impact on usability from both a risk management and ease of use perspective. Packaging can deliver a positive experience for intended access by using an intuitive sequence aligned with a purposeful workflow. The packaging can accentuate labeling of criticality through the physical arrangement of the device in the packaging and associated labeling. Additionally, labeling can minimize contamination by directing users to remove surgical instruments from packaging in the purest way into the sterile field.
In quality assurance (QA) programs, manufacturers must incorporate several elements that relate to labeling to meet the good manufacturing practice (GMP) requirements of quality system regulations. It must ensure that labeling meets the GMP device master record requirements with respect to legibility, adhesion and placement, and ensure that the correct labeling is always issued and properly applied.
Medical device packaging influences
Understanding and addressing how packaging can influence device preparation and deployment is important due to the potential for use in different environments.
For example, medical device usage at home is growing exponentially. The home medical device market could reach $57.1 billion in 2028 with a compound annual growth rate (CAGR) of 7.0% from 2021 to 2028, according to Insight Partners. It makes sense that the $29.8 billion medical device packaging market would follow with a CAGR of 6.4% from 2020 to 2028, according to Grand View Research.
Looking at the many aspects of the packaging design of medical devices, it’s clear that HFE can help direct packaging development processes beyond conducting usability after design development. For instance, when the HFE team analyzes the workflow for care delivery using task analysis, it assesses the user’s interaction with the packaging, including all its layers (primary and secondary packaging), which is one of the initial tasks in the analysis.
The value of task analysis
HFE task analysis often reveals design packaging opportunities to enhance workflow efficiency by designing functionality that does more than protect the device during shipping and storage.
Medical device manufacturers use HFE task analysis to outline the device kit contents and their purpose as well as how to deliver safer passage for a device from its packaging to the sterile field. It prioritizes the device kit contents in the order of use. The task analysis provides a staging area for device usage and deployment that enables better access to labeling (like a quick reference guide), more efficient storage and better access to stored packaging.
The task analysis typically will not increase the recurring production cost of the packaging. Adding features to a thermoformed tray to organize and stage the contents may increase design and testing time, but the packaging production cost stays the same if the overall dimensions of the tray have not changed.
Start packaging and labeling HFE earlier
To alleviate stress and minimize risk and costly surprises, factor medical device packaging and labeling early in the development process. Prioritizing packaging and sterilization at the onset of the design process facilitates commercialization and can accelerate time to market.
Packaging design and development used to happen during the last few stages of the medical device development process. But now, using HFE early on when designing the packaging system and selecting the appropriate materials, stress is alleviated during the commercial launch.
A packaging design process started early will not only create a more effective product but will reduce timeline risks and any cost surprises of the packaging materials.Sean Hägen is a founder, principal and director of research and synthesis at BlackHägen Design, an R&D consultancy focused on medical device innovation. He has over 30 years of research and production development experience and serves in the management of user research and insight translation phases of product development for BlackHägen’s clients in medical device and other industries.
Editor’s note: Hägen died Feb. 25, 2022 after a brief illness.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.