Human Factors in Translation: Turning Research into Actionable Design for MedTech
Successful medical device development thrives on the seamless collaboration of multidisciplinary experts across various domains. In the field of engineering alone, mechanical, electrical, industrial and human factors (HF) specialists all play separate–but–related roles in the creation of a superior health product.
The discipline of HF (also known as “usability engineering”) focuses on designing for known human capabilities and limitations to increase safety and effectiveness by improving usability. Foundational HF activities include early research on an intended user’s attributes (physical/cognitive limitations, size/strength, literacy level, etc.) to inform design. Throughout product development, simulated use studies are conducted to verify that the product is tailored to fit the user’s physical and situational needs, culminating with a summative validation study to prove the product is safe and effective for use.
In the world of healthcare and medical technology development, the importance of HF work is compounded. Directly impacting patient outcomes and healthcare professional workflows, systems must be intuitive, safe and efficient to ensure best results and avoid adverse reactions. But you don’t have to take our word for it. The U.S. Food and Drug Administration (FDA) and other regulatory bodies require adherence to human factors processes in medical device development (e.g., IEC 62366-1, FDA HFE Guidance, ISO-14971).
Building a Better Blueprint
Effective HF research provides a deeper understanding of users and helps identify design opportunities that can address safety risks and/or differentiate a product. One of the challenges in integrating HF research is effectively interpreting and communicating subjective or nuanced human responses — the key to understanding real-world use — to downstream engineering teams. Due to this complexity, HF is often treated as a separate workstream. This siloed technique leads to limited integration of HF input, undermining how its data is used to optimize the usability and effectiveness of a final product.
A consistent HF presence throughout the development process yields a high return on investment (ROI) — allowing teams to identify and address critical use risks early before changes become costly at the end of the product development cycle. At EPAM Continuum, our HF input is continuous, from early generative research through regulatory submission. As a result, we’ve developed — and put into practice — three impactful techniques to improve collaboration among multidisciplinary design teams and maximize the value of usability research.
Technique #1: Facilitating Collaborative Iterative Testing
Downstream engineering and design teams often wait weeks or months before receiving HF research insights in a formal report. Without seeing observed issues or user feedback first-hand, downstream teams must rely on this report to understand the full context of insights, which can lead to misunderstandings and/or miscommunications.
Solution:
Integrating engineering and design teams into the research process helps bridge the gap between research insights and actionable changes by reducing opportunities for miscommunication. One such approach that has proven successful is designing HF studies that include rapid iterative prototype testing. A physical or digital product design is evaluated by users on the first day with the entire cross-functional team observing, rapidly redesigned based on users’ feedback and an expedited team debrief, and then reevaluated with new users on the next day (followed by another design iteration).
Value-Add:
Supported by in-house observation and prototyping labs, this practice allows engineering and design teams to collaboratively observe and discuss design-related insights in real time, reducing the typical burdens related to handoff and streamlining the overall development process.
Technique #2: Ensuring Actionable Root Causes
Root cause analysis is a powerful tool in HF research that allows practitioners to understand the exact design features and behavioral influences that lead to user issues with a device. Failure to sufficiently communicate root causes to downstream teams can lead to significant complications, ranging from ignored device flaws to misdirected design efforts.
Root causes that place blame on the user or fail to identify an underlying issue with the system’s design do not provide any actionable information. Alternatively, issues can arise when reported root causes overstep by prescribing a solution to an observed issue instead of providing a sufficient description of the nature of the issues themselves.
Solution:
Write effective and actionable root causes, capturing three key elements: relevant context to the use error or difficulty, identification of a specific design feature of the product system and a succinct description of the underlying issue observed.
Value-Add:
By integrating these elements into root causes, downstream teams are provided with sufficient context to drive impactful design changes for a device. Similarly, they have a wealth of actionable information to make their own expert decisions on what’s best for the design, rather than having solutions prescribed to them.
Technique #3: Prioritizing Findings Using HF’s Risk-Based Approach
Design improvements can often get lost in the prioritization of research results. While a particular HF study may yield many potentially helpful insights, the mere presence of multiple findings can lead downstream teams to focus their attention in the wrong places and/or assign priorities without appreciating the full context.
Solution:
HF researchers can help prevent these issues by clearly and proactively prioritizing research findings based on the severity of potential harm (and not by frequency of occurrence). Often, success with this technique involves additional coaching of downstream stakeholders on said risk-based prioritization approach — particularly on the relative impact of “critical” versus “non-critical” tasks (including a deeper nuance of how “critical” tasks include various harm severity categories). Prioritized findings should be included in a highly visible area of a study report, such as the executive summary.
Value-Add:
With an understanding of task criticality, focus can be placed on design improvements that eliminate the most severe usability issues. Prioritized findings ultimately reduce potential harm to users.
This research was presented at the Human Factors and Ergonomics Society (HFES) 2025 International Symposium on Human Factors and Ergonomics in Health Care — view our full poster here.
Putting Humans at the Center of Design
Integrating HF research and improving the transfer of information to downstream teams is essential for fostering innovation in life sciences and healthcare. Successful information sharing and multidisciplinary collaboration ensure that medical technology designs are not only functional but also safe, user-centered and aligned with the needs of regulatory bodies and other stakeholders. HF research is the reason our design teams have helped clients enhance care, improve outcomes and set new quality standards for the medical industry.
At EPAM, and in our EPAM Continuum studio in Boston, several setups and spaces make this collaborative research possible. Learn more about EPAM’s MedTech practice and in-house Physical Technology Development and human factors expertise.