In the intricate realm of healthcare, the design of medical devices plays a pivotal role in ensuring patient safety and treatment efficacy. One often overlooked aspect of this design process is the packaging that houses these life-changing devices. Human factors engineering (HFE), also known as usability engineering, stands at the forefront of this endeavor, emphasizing the need for medical device sterile packaging to be meticulously crafted for ease of use.


HFE encompasses a profound understanding of human behavior, abilities, limitations, and other characteristics that directly impact the interaction between users and medical devices. It extends its influence to mechanical and software-driven user interfaces, instructional documentation, packaging, labeling, and user training, including the utilization of advanced medical device packaging machines. As an integral component of product design, HFE should be applied from the inception of a product-design initiative and should persist throughout the entire development process.


Regulatory bodies, such as the FDA, underscore the significance of packaging and labeling as integral parts of the medical device user interface. These components undergo a rigorous validation process to demonstrate safe and effective use. The usability of packaging becomes a critical design consideration, emphasizing the proactive application of HFE principles to ensure user acceptance and successful validation.


The healthcare industry places substantial emphasis on integrating packaging and labeling early in the medical device product development process which alleviates stress, minimizes risks, and eliminates costly surprises. Beyond user satisfaction, the proper design of medical device packaging significantly impacts patient safety. Regulatory authorities, particularly the FDA, prioritize risk management and the elimination of potential use errors that could result in harm during clinical care outcomes.


Packaging and labeling are intertwined aspects of medical device user interfaces, making it challenging to separate one from the other. While labeling is often considered part of packaging, both elements contribute to the overall usability of medical devices. Mechanical and industrial design of the packaging can profoundly influence usability from both a risk management and ease-of-use perspective.


For instance, the packaging design can enhance the user experience and patient safety by providing an intuitive sequence aligned with a purposeful workflow. On the contrary, deficiencies in packaging design may introduce potential use errors, impacting risk management and patient safety.


HFE task analysis plays a pivotal role in identifying opportunities for packaging design improvements. By outlining device kit contents and their purpose, task analysis ensures safe passage for a device from its packaging to the sterile field. Prioritizing device kit contents in the order of use, creating a staging area for device usage, and enabling better access to labeling are key outcomes of task analysis. This not only enhances workflow efficiency but also contributes to a better user experience.


Packaging design reaches new heights when HFE principles are integrated early in the process. Going beyond usability evaluations during product development cycles, prioritizing HFE from the onset delivers a superior user experience and ensures safe execution. Early involvement in the design process facilitates commercialization and can accelerate time to market.


Previously, packaging design occurred in the later stages of medical device development, but with the application of HFE principles early on, stress is alleviated during commercial launch. This proactive approach not only creates a more effective product but also reduces timeline risks and surprise costs associated with packaging materials.


As we step into the future, anticipate a wave of packaging innovations designed to further enhance patient safety and streamline healthcare processes. Technologies such as 2-D barcodes with unique numbering/serialization, UV identification codes, holograms, or hidden text printed using security or magnetic ink are expected to safeguard against product counterfeiting. These advancements underscore the ever-growing importance of sterile packaging in the overall success of medical device designs.


Human factors engineering is reshaping the landscape of medical device packaging, emphasizing the need for designs that prioritize ease of use. From regulatory considerations to the impact on patient safety and satisfaction, HFE principles are driving innovation and efficiency in the packaging of medical devices. The current and future innovations at Van der Stahl Scientific hold exciting possibilities as technology continues to intersect with healthcare, ensuring that medical device packaging remains a cornerstone in the quest for superior patient outcomes.



Human factors and packaging: Adventures in medical device usability. Medical Device and Diagnostic Industry. (2023, November 22). 

Human factors engineering considerations for medical device packaging. Human Factors Engineering Considerations For Medical Device Packaging. (n.d.).