What is Human-Centered Design?
Human-centered design plays an important role in designing packaging for the end user, impacting how we approach the development of medical products and pharmaceuticals. In an era where complexity in healthcare solutions continues to grow, human-centered design emerges as a critical framework, guiding the integration of technology, regulatory insights, and user behavior.
Human Factors and Use-Related Risk Analysis
An important piece of human-centered design is the volume of dual therapies hitting the market. Combo kits integrate both a medical device and a medication—and possibly other components. Last year’s final guidance from the FDA calls out the importance of applying human factors (HF) through two lenses: holistic for safe and efficacious end-use and by piece, to ensure understanding of each component for proper assembly and dispensation.
With its July 2024 draft guidance, the FDA sought to “increase the safe use of drug products by minimizing use error that is related to the naming, labeling, packaging or design of drug products.” Specifically, the initiative aims to design a use-related risk analysis and a human factors validation study protocol. The tools provide a framework to address potential hazards and user errors that exist in combination products as a unit (not individual components). In addition to combination products, new drug application non-prescription drugs are also addressed. For now, the agency did not include specific guidance on HF studies and analysis. What they did express is the hope that the Use-Related Risk Analysis will provide a strong foundation throughout product development that will reveal relevant HF validation data.
Human Factors and The American National Standards Institute
Where the FDA’s use-related risk analysis guidance seeks to improve and oversee quality relating to pharmaceutical combinations, medical device makers are on watch for the pending ANSI/AAMI HE75:2024 human factors standard update. The 2018 revision to the original ANSI/AAMI HE75:2009 standards offered MDMs the basics of HF engineering and design for medical device development. As we’ve noted, the role, breadth, and depth of HF engineering has transformed in recent years. Some of the pending HE75:2024 update focuses on use error risk and on-device labeling. It also contains new sections to align with the FDA’s 2024 guidance regarding integrated systems and combination products. Overall, this substantial revision is expected to provide clearer alignment with the FDA and to also offer HF engineering specifics.
Human Factors and AI
Next in HF evolution is something that every industry and enterprise is grappling with, for better or for worse: the role of artificial intelligence in medical product packaging and design. Because AI can process data with incredible speed and efficiency, there are clear opportunities to streamline and expedite design processes—and contribute to risk assessments, including use-related risk analysis. There will be a lot of discourse ahead on AI for our industry. Do regulatory agencies look to AI for advice? What about data privacy? Can AI be applied without exhibiting accidental bias?
With impressive predictive analytics capabilities, AI could also be a valuable tool to process data on patient/user behaviors as they interact with medical product packaging. Not only could this speed up the iterative design process, but it could also identify potential risks before the product hits the shelf.
Technology and Human Interaction
With technology significantly impacting the direction of HF engineering in medical packaging, it would be remiss not to mention how smart packaging is playing into the field. Particularly for pharmaceuticals. HF is integrating near-field frequency chips (NFC) into packaging to help patients confirm the medicine is authentic and alert to possible tampering. The tags can even work with a patient’s phone to track dosing and time-sensitive medication alerts.
Similarly, QR codes continue to evolve in practicality as the day-to-day use of technology is engaging even senior populations thanks to HF understanding of effective, simple actions. The codes are a cost-effective means of giving clinical and at-home users fast access to educational content or scientific details.
Understanding and applying the realities of human interaction with a package and its contents may seem more like psychology than engineering. Yet, in the end, it is just that human interaction that tells us exactly what the packaging design process must accomplish for success. Human-centered design, as defined by human factors is not only here to stay, but to lead the way.
