A manufacturer’s responsibility does not end with the launch of a medical device – it just begins. Post-market surveillance (PMS) plays a critical role in ensuring long-term safety, performance and compliance.
However, traditional PMS methods often fail to capture all relevant use patterns and risks. In this article, you will learn why user research is a valuable addition to traditional PMS data and how it can help you continuously optimize your product.
1. A quick recap: What is post-market surveillance and what do I need to do as a manufacturer?
Post-market surveillance (PMS) is a regulatory requirement that requires medical device manufacturers to systematically monitor their products after they have been introduced to the market. The goal is to ensure that products continue to meet safety and performance requirements and to identify potential risks early.
To do this, manufacturers must take a number of steps, including:
- Collect real-world data to identify potential safety and performance issues
- Periodically generate PMS reports to analyze the collected data and take action when necessary.
- Initiate corrective actions when problems are identified to ensure the safety and effectiveness of the product.
Many companies rely on traditional methods of data collection. But is that enough?
2. The limitations of traditional PMS data
Many manufacturers rely primarily on passive data sources to capture incidents. These include:
- Complaint systems: Documentation of customer and user complaints.
- Adverse event databases: Adverse event reports collected by regulatory agencies or hospitals.
- Hotlines and service portals: Users can report common problems, questions, or suggestions for improvement.
These sources are valuable because they provide continuous data. However, they have a major drawback: problems are only captured if they are actively reported. Many (so-called latent) problems go undetected because they are not perceived as serious or are simply not reported.
For many years, various organizations have called for the use of active methods in post-market surveillance. One example is the 2014 BSI white paper “Effective post-market surveillance” (source), which emphasizes the importance of early proactive PMS measures. The 2024 GAO report (source) also calls for increased use of active PMS methods, particularly through better use of data from real-world use situations.
The WHO “Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics” of 2021 (source) also mentions observing users during training as a complementary PMS method.
We also suggest systematically integrating user research into PMS to identify latent problems early. But why?
3. Why user research is a crucial complement
User research is a systematic approach that combines quantitative and qualitative methods to:
- understand users and their needs
- analyze the work environment, and
- study the interaction with the product.
The methods include:
- Observations: Analysis of user behavior in the real environment.
- Interviews: Direct conversations provide deeper insight into challenges and needs.
- Metrics: Quantitative metrics complement the understanding of usage.
In contrast to passive (reactive) PMS data, user research provides a more comprehensive insight into the usage situation. This makes it possible to identify latent problems at an early stage.
4. Concrete benefits of user research for PMS
As a UX agency that supports manufacturers in user research, we see the following benefits:
1. Early detection of latent problems
Example: A usability study revealed that users often skip a critical calibration step because it was not clearly communicated. Such errors often remain invisible in complaint systems.
2. Proactively implement corrective actions
Identifying problems early allows you to take preventative action before they have a serious impact. This saves money and protects the company’s reputation.
3. Increase customer loyalty
Involving users directly in the development process shows that their opinions are valued. This builds customer loyalty and helps ensure that products are perceived as tailored solutions that are optimized for their needs.
4. Sustainable improvement of product quality
In addition to safety aspects, usability weaknesses can also be uncovered. Improvements in these areas increase user satisfaction and efficiency.
5. Demonstrate compliance with regulatory requirements
User research verifies that a manufacturer not only meets the minimum requirements, but goes above and beyond. This makes it easier to argue with notified bodies in the PMS report and ensures that the company is on the safe side.
6. Gain “positive” data
While traditional PMS methods provide mostly negative data about failures or incidents, integrated user research allows for a broader collection of data. In addition to problem areas, manufacturers also receive feedback on the most successful aspects of their product, as well as suggestions for improvement that are not necessarily related to critical defects.
It can also provide valuable insight into how the product is used compared to competitive products. These insights are critical to the development of the next generation of products, as they show exactly which features are needed and which are not – saving time and money.
7. Direct recruitment for future usability studies
Regular contact with users in the context of user research creates a pool of potential participants for usability testing of future product generations. This makes the planning and execution of studies much easier.
5. Conclusion: User research as an essential part of post-market surveillance
Traditional post-market surveillance provides valuable data – but it is not enough to get a complete picture of how your product is actually used. Latent errors, optimization potential and real barriers to use often remain invisible if manufacturers rely only on complaint systems and reported incidents.
User research fills these gaps. It provides deeper insights, uncovers unrecognized problems, and helps target optimization early – before regulatory or safety challenges arise. In addition, it enables not only better product quality and customer satisfaction, but also a stronger market position through well-founded product improvements.
How does your organization integrate user research into the PMS? If you need support in this area, we can help you with our experience in usability studies, user interviews and realistic tests for medical devices and IVDs.
Contact us for a no-obligation initial consultation – we will show you how to integrate user research into your PMS in a meaningful way!
