As innovation blurs the line between drug and device, combination products are becoming increasingly common. These products—such as pre-filled syringes, autoinjectors, inhalers, or drug-eluting implants—must satisfy not only pharmaceutical standards but also those of medical device functionality. In this complex landscape, one aspect is often underestimated but critical for both safety and approval: human factors engineering. Regulatory agencies now view usability as integral to product design, and failing to account for human interaction can delay approvals, trigger recalls, or even compromise patient safety.
Human factors engineering (HFE) is the discipline of designing products that account for how users interact with them—physically, cognitively, and emotionally. In the context of combination products, this means evaluating how healthcare professionals and patients use the device component during drug delivery. Can the user intuitively operate it? Are the instructions clear? What happens if the product is used incorrectly? These are questions regulators want answered—and documented—before a product hits the market.
The FDA requires human factors data as part of the premarket submission for many combination products, especially when incorrect use could lead to serious harm. According to FDA guidance, a rigorous human factors validation study is necessary to demonstrate that critical tasks can be performed safely and effectively by the intended user population. This is particularly important for self-administered products, which are often used by patients with limited medical training or physical impairments. A poorly designed interface can result in dose errors, contamination, or even patient injury, all of which carry regulatory consequences.
In addition to user safety, human factors influence product adoption and market success. A drug-delivery device that is uncomfortable, confusing, or difficult to operate may suffer from poor patient adherence, even if the drug itself is effective. For manufacturers, this creates a dual challenge: designing for usability while meeting stringent regulatory requirements. This involves early-stage formative studies, iterative design improvements, and formal validation studies—all documented in a way that supports FDA or EMA approval pathways.
EMMA International provides comprehensive support to life science companies integrating human factors into their combination product development. Our team assists with usability risk assessments, study design and execution, and documentation that aligns with FDA’s Human Factors Guidance and IEC 62366 standards. Whether you’re submitting a New Drug Application (NDA) or a 510(k), we help ensure that your product not only works—but works for the people who need it most.
As combination products continue to transform the therapeutic landscape, human factors will play a pivotal role in their success. Integrating usability into the design process early on doesn’t just improve safety, it accelerates time to market and drives user trust. With EMMA International, you’ll have a partner that brings regulatory clarity and user-centered insight to every stage of your product’s journey.
Have questions about human factors integration for your combination product? Contact EMMA International at 248-987-4497 or email info@emmainternational.com to learn how we can help you ensure both usability and compliance.
References [1] U.S. Food and Drug Administration (2023). Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Medical Devices. Retrieved on 23 March 2025 from: https://www.fda.gov/media/80481/download
[2] European Medicines Agency (EMA) (2024). Guideline on the Quality Requirements of Drug-Device Combination Products. Retrieved on 23 March 2025 from: https://www.ema.europa.eu/en
[3] ISO (2015). IEC 62366-1: Application of Usability Engineering to Medical Devices. Retrieved on 23 March 2025 from: https://www.iso.org/standard/63179.html
