The Power of Heuristic Analysis Early in Medical Device Development
How conducting a heuristic analysis can unlock early insights and prevent costly design rework
In the development of medical devices and combination products, identifying and addressing usability issues is paramount to ensure patient safety, user satisfaction, regulatory compliance, and ultimately, commercial success.
While usability studies are a cornerstone of Human Factors (HF), they are not the only tool in our HF toolkit. One particularly powerful, yet often underutilised method is heuristic analysis: a structured, expert-led review of a device’s user interface (UI) against established usability principles.
In this article, Laura McDowall and Annmarie Nicolson, Principal HF Consultants at We Are Human, spotlight the real-world impact of conducting heuristic analysis early in the design process, sharing insights from a recent case study that highlights its value in identifying critical usability risks before they become costly to fix.
What is Heuristic Analysis?
Heuristic analysis is a method where experts evaluate a user interface (UI) against established usability principles (“heuristics”) to identify potential usability issues.
Jakob Nielsen developed the original 10 usability heuristics (see Figure 2) in the 1990s. When combined with Shneiderman’s eight “Golden Rules” of interface design, practitioners often expand the set with four additional heuristics: Memory, Feedback, Clear Close, and Language. This combined set of 14 heuristics provides a comprehensive framework for evaluating design effectiveness and usability.
Although heuristic analysis is not a substitute for usability testing with actual end users, it offers a valuable, expert-led diagnostic approach. By systematically identifying potential usability issues early in the design process, teams can address concerns proactively, before entering more time-consuming and costly phases of development and testing.
What makes heuristic analysis particularly powerful is the breadth of experience brought by HF professionals. Drawing on insights from a wide range of users and products, they provide an unbiased, cross-contextual perspective that helps reveal design pitfalls that might otherwise be overlooked.
Case Study: Evaluating a Combination Product User Interface
One of our trusted clients, a global medical device manufacturer, approached us early in the development of a new combination product. With an eye toward future clinical studies and FDA submission, they wanted to proactively evaluate the usability, safety, and effectiveness of the product’s UI.
We Are Human kickstarted the project by developing a tailored Human Factors Engineering Plan (HFEP) aligned with applicable standards and regulatory guidance. This roadmap outlined a series of HF activities, including user research, heuristic analysis, expert reviews, intended use specification, use-related risk analysis (URRA), including perception, cognition & action (PCA) analysis, known use problem analysis (KuPA), and both formative and summative usability studies.
One of the first activities we undertook was to conduct a heuristic analysis of the device’s UI. Over just 2–3 days, two of our HF specialists carried out an independant heuristic review including:
- Walkthroughs of key intended use scenarios
- Detailed assessment of device UI including labelling and instructions
- Collated and aggregated the key findings
The outcome? A list of prioritised usability issues with the potential to impact safe and effective use. These were presented in a visual, actionable report complete with annotated visuals, severity ratings, and design recommendations.
The heuristic analysis represented just 5% of the total preliminary HF investment* for this project.
(*Note: preliminary HF spend included HFEP, heuristic analysis, intended use specification, KuPA, URRA incl. PCA, and a formative usability study.)
Several Months Later: Formative HF Study
Several months later, we conducted a simulated-use formative usability study on the same UI, with intended users, at our research venue in Atlanta. This comprehensive effort included planning, protocol development, Institutional Review Board (IRB) submission, participant recruitment, usability testing across multiple user groups, and detailed data analysis, reporting and presentation.
This phase lasted four months and represented 65% of the overall preliminary HF investment.
Experienced HF professionals know that the value of a formative study extends well beyond identifying use problems. It’s about exploring how users interact with the device, assessing risk mitigations, uncovering root causes and informing design decisions.
That said, what we found particularly noteworthy in this case was how effective the preliminary activities (including the heuristic analysis) were in anticipating the issues later confirmed in testing. Specifically:
- 30% of the usability issues observed during the formative study had already been identified during the heuristic analysis.
- When reviewed in combination with the known / foreseeable use problems identified in the KuPA and URRA (including PCA analysis), 86% of the total issues encountered in the formative study had been identified in advance.
Put simply, only 14% of the use problems revealed during the formative testing were truly new, meaning the vast majority had already been predicted through preliminary, lower-cost HF activities.
Figure 4 below shows where the use problems identified in the formative study were originally detected, by percentage.
The Case for Heuristic Analysis: 5 Key Takeaways
1. Early Insight, Minimal Investment
With just a small fraction of the overall budget, our client gained early awareness of key usability concerns. These insights gave the team time and flexibility to iterate and refine the UI before reaching more resource-intensive phases, such as clinical trials and regulatory submissions.
2. Design Iteration Becomes Easier and Cheaper
Identifying and addressing potential issues early allows for low-cost design modifications. Waiting until later can lead to costly rework across hardware, software, packaging, labelling, training materials, and testing protocols.
3. Regulatory De-Risking
Regulators increasingly expect medical device developers to demonstrate a robust, well-documented HF process. Heuristic analysis is a recognised method, cited in key standards and guidance documents including:
FDA Human Factors Guidance (2016) – Section 6.3.2
IEC 62366-1:2015 (R2020) – Section 3.27
IEC/TR 62366-2:2016 – Section 16.2.2
ANSI/AAMI HE75:2009 (R2018) – Section 9.3.7.4
AAMI TIR59:2017 – Sections 2.43, 7.2, and 9.2
Incorporating heuristic analysis early in your HF process can reduce the risk of late-stage usability surprises, strengthen regulatory submissions, and demonstrate due diligence in identifying and addressing use-related risks.
4. Strategic Resource Allocation
Early expert reviews help organisations identify and mitigate use-related risks earlier in development, enabling formative usability testing to focus on assessing design improvements and demonstrating the effectiveness of risk controls, rather than surfacing issues that could have been prevented.
5. A Smarter Way Forward
Heuristic analysis isn’t a replacement for formative studies. Each serves a unique purpose within the HF process.
We’re seeing increasing interest in heuristic reviews as an early-stage screening tool: an efficient, cost-effective way to screen designs, improve UI early, and shape smarter HF usability (and clinical) studies.
In a time where speed-to-market and cost efficiency are more important than ever, integrating heuristic reviews into your design control process is a smart, evidence-backed move.
Final Thoughts
The data from this project speaks volumes:
- 30% of the use problems encountered in the formative usability study had already been identified during the heuristic analysis (See Figure 4)
- The heuristic analysis represented just 5% of the preliminary usability investment (See Figure 6)
- It took just 2-3 days to complete the heuristic analysis
When deep in the details of development, it’s easy to overlook usability issues hiding in plain sight.
A well-executed heuristic analysis can help teams see the forest for the tees and provide a fresh, structured perspective, highlighting actionable insights that lead to better, safer products without requiring significant investment.
Up Next: Stay tuned for our next article, where we explore how use-related risk analysis (including PCA analysis) shaped the development process for this very same product.
Need help spotting potential usability risks early?
We Are Human can help you: Identify key usability challenges early, reduce costly redesign, accelerate development timelines and create safer, more effective products
Sources
Thyvalikakath, T.P., Monaco, V., Thambuganipalle, H. and Schleyer, T., 2009. Comparative study of heuristic evaluation and usability testing methods. Studies in health technology and informatics, 143, p.322.: https://pmc.ncbi.nlm.nih.gov/articles/PMC2736678/
Zhang, J., Johnson, T.R., Patel, V.L., Paige, D.L. and Kubose, T., 2003. Using usability heuristics to evaluate patient safety of medical devices. Journal of biomedical informatics, 36(1-2), pp.23-30. :https://pubmed.ncbi.nlm.nih.gov/14552844/
Jeffries, R. and Desurvire, H., 1992. Usability testing vs. heuristic evaluation: was there a contest?. ACM SIGCHI Bulletin, 24(4), pp.39-41.): https://dl.acm.org/doi/abs/10.1145/142167.142179
Nielsen, J. and Molich, R., 1990, March. Heuristic evaluation of user interfaces. In Proceedings of the SIGCHI conference on Human factors in computing systems (pp. 249-256).: https://dl.acm.org/doi/abs/10.1145/97243.97281
Nielsen, J., 1994. The theory behind heuristic evaluations. Nielsen Normal Group: https://www.nngroup.com/articles/how-to-conduct-a-heuristic-evaluation/theory-heuristic-evaluations/
U.S. Food and Drug Administration. (2016). Applying human factors and usability engineering to medical devices: Guidance for industry and Food and Drug Administration staff https://www.fda.gov/media/80481/download
IEC 62366-1:2015 (R2020): Medical devices—Part 1: Application of usability engineering to medical devices
IEC/TR 62366-2:2016: Medical devices—Part 2: Guidance on the application of usability engineering to medical devices
ANSI/AAMI HE75:2009 (R2018): Human factors engineering—Design of medical devices
AAMI TIR59:2017: Integrating human factors into design controls
