Human Factors in biomaterials: a practical advantage for product development and regulatory success

Christina Mendat, Vice President, Eurofins Human Factors MD

Why this matters now

Biomaterials are sometimes treated as “straightforward” to evaluate because performance testing and biocompatibility data do so much of the heavy lifting. In practice, however, real world outcomes also depend on how clinicians interpret labeling, choose application techniques, and integrate a biomaterial into established standards of care. For product developers, human factors (HF) methods provide a structured way to surface these use-related variables early, supporting design decisions, strengthening risk management, and building clearer regulatory rationale.

Human factors isn’t just for active devices

HF engineering is often associated with active medical devices, delivery systems, and combination products, but the same principles strengthen biomaterials programs. Even when the intended user is a trained healthcare professional, variability in experience, time pressure, and site practices can influence whether the product is applied as intended—and whether key limitations are recognized at the point of use.

As biomaterials diversify in mechanism and handling requirements, HF studies can confirm that the “product system” (packaging, labeling, instructions, and workflow fit) reliably supports correct use across care settings.

The Role of Human Factors in biomaterials evaluation

Traditional biomaterials testing focuses on material properties, sterility, degradation, and biological response. HF complements these evaluations by addressing how users interpret the instructions for use, make choices during application, and incorporate the biomaterial into existing clinical workflows.

In biomaterials programs, HF evaluations can include:

• Understanding of intended use and limitations
• Interpretation of labeling and instructions
• Application techniques and dosing assumptions
• Compatibility with existing standards of care
• Recognition of contraindications and warnings

This perspective is especially useful when formal training is limited or inconsistent, or when products are used across multiple sites of care.

Labeling as a high value risk control

HF testing often shows that the most important information—contraindications, application limits, and compatibility considerations—needs to be easy to find, easy to scan, and clearly differentiated. Content that is technically present but hard to locate (or embedded in dense text) is less likely to be used at the moment it matters.

Because training approaches can vary by site and over time, HF practice encourages designing the full product system (including packaging, labeling, and instructions) to support safe and effective use without relying on memory or specialized experience. In wound care, where users may range from highly specialized clinicians to generalists working in diverse settings, this design-for-clarity approach is particularly impactful.

What to do with this: practical takeaways

For developers and regulatory teams, HF offers a practical bridge between design intent and real world use. It strengthens your usability related risk analysis, clarifies labeling rationales, and generates evidence to support safe and effective use in the intended environment.

• Build HF checkpoints into development: evaluate use steps, decision points, and workflow fit before design is “locked.”
• Treat labeling and instructions as design outputs: test for findability and comprehension, not just completeness.
• Use HF results to support regulatory narratives: connect observed use needs to mitigations and risk controls in your documentation.

By incorporating human factors testing early and iteratively, developers can identify and mitigate use related risks that may otherwise go undetected until post market use. This approach supports regulatory expectations, product adoption, correct usage, and patient outcomes. For more information, visit: Human Factors MD - Human Factors, Medical Devices