Human Factors in Post Market Surveillance: Beyond Complaints and Adverse Events

By Yvonne Limpens 

When a medical device reaches the market, its launch should not be the end of its human factors (HF) journey. It is the start of a new phase where real-world use generates insights premarket usability studies cannot fully capture. Post-market surveillance (PMS) is the mechanism enabling manufacturers to gather those real-world insights, thereby enabling them to identify emerging risks, address usability challenges and act proactively to keep devices safe and effective throughout their lifecycle. 

The regulatory perspective 

Both the EU MDR and FDA place strong emphasis on PMS. Regulators expect manufacturers to demonstrate not only that devices function as intended upon submission, but that they continue to be usable and safe in practice over time. Integrating HF into PMS activities directly supports these expectations and strengthens the evidence for ongoing compliance. 

How HF enriches PMS efforts 

Traditional PMS efforts often focus on clinical outcomes, technical performance, or adverse events. However, many issues that arise from the field, as well as many that may never escalate to formal complaints, can stem from how users interact with the product. Missteps in handling, unclear instructions, or unmet user needs can all contribute to safety-related risks, inefficiencies and dissatisfaction. 

HF integration in PMS helps manufacturers not only collect issues that are difficult to spot but also understand why these issues occur. By integrating HF methodology and perspective into PMS efforts, manufacturers can: 

• Differentiate use errors from product failures through understanding when issues arise from design, instructions or user interaction rather than mechanical malfunction. 
• Identify additional and/or refine existing critical tasks by focusing on the interactions most essential to safe and effective use. 
• Spot use-safety trends early by analyzing complaints and adverse event data to detect usability issues before they escalate. 
• Optimize the fit between the device and users’ life or workstyles by understanding how devices are integrated into daily routines and where friction points occur. 

Activities like these generate meaningful feedback that can be translated into actionable insights, for example helping refine the use-elated risk analysis, improve instructions for use (IFU) and guide user interface (UI) updates.  

For manufacturers, this means stronger regulatory defensibility, fewer surprises and reduced risk of costly CAPAs or recalls. For users, it means safer devices, clearer instructions and products that better support their real‑world needs. For users, the value is improved safety, clearer instructions and devices that better support their real‑world needs. In short, HF‑informed PMS offers a strong return on investment by improving both product performance and user experience. 

A strategic opportunity 

Embedding HF into PMS fills a critical gap in understanding how products are actually used in the real world. Over time, devices may evolve, user populations may shift and use environments may change, often in ways that traditional PMS activities do not fully capture. By actively monitoring and responding to usability-related signals, manufacturers can adjust to these evolving patterns in a timely manner and better promote patient safety, user acceptance and long‑term satisfaction. 

As such, PMS should not stop at capturing complaints because even small enhancements to PMS processes, such as incorporating HF methods, can track shifts in user behavior, mental models and interaction patterns over time. HF-related post-market data could reveal that users may reinterpret or misremember instructions, develop workarounds or experience “usability drift” (i.e., the gradual evolution of user-device interactions in ways the design team did not anticipate). HF provides the why behind these patterns, not just the what. 

Methods such as post‑market usability studies, targeted surveys, structured interviews and contextual inquiry help uncover the underlying reasons behind these shifts, providing context that complaint data alone cannot capture. Moreover, proactive monitoring tools, such as QR-coded feedback portals and embedded user experience (UX) analytics, can offer continuous visibility into how diverse user groups interact with devices. Standard consumer sector metrics, such as task abandonment rates, dwell time or feature engagement, can reveal latent usability issues in medical devices and consequently inform (re)training strategies, IFU updates or UI refinements. 

Integrating HF and UX analytics into PMS creates a multidimensional “listening” strategy that goes beyond often poorly-captured adverse events and complaints. This proactive approach helps manufacturers spot emerging risks early on and, as needed, initiate corrective actions before harm occurs or design (next-generation) medical devices that evolve with both users and healthcare systems. 

Contact our team to learn more about integrating HF in your PMS efforts.  

Yvonne Limpens is a Managing Human Factors Specialist at Emergo by UL.