Conducting Effective Post-Market Surveillance for Health Technology Companies

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Key topics in this article…

  • What is post-market surveillance and why it matters
  • Regulatory requirements for health tech companies
  • Methods to collect real-world user experience and outcomes data
  • Using peer and clinical reviews to validate product performance
  • Best practices for implementing effective post-market surveillance

The Imperative for Ongoing Monitoring

This article explores why post-market surveillance is essential, outlines the methods companies can use to gather meaningful post-market evidence, and highlights how this process drives not only compliance but also innovation and trust.

Post-market surveillance (PMS), also known as in-market surveillance refers to the collection and analysis of data about a product’s performance, safety, and user experience once it is commercially available. Regulatory frameworks globally, such as the EU Medical Device Regulation (MDR 2017/745) and the FDA’s Post-market Surveillance directives, make this mandatory for many classes of medical devices and digital health products.

The reasons for this requirement are clear:

  1. Patient Safety: Real-world use conditions can differ significantly from clinical trials and controlled pilot studies. Post-market surveillance ensures that unforeseen issues, adverse events, or new risks are detected promptly and mitigated.
  2. Regulatory Compliance: Regulatory bodies increasingly require demonstrable evidence that a product continues to meet safety and performance standards throughout its lifecycle.
  3. Safeguarding and Liability: Gathering robust in-market data helps companies prove that they have taken reasonable steps to identify and manage risk, which can protect against legal liability if something goes wrong.
  4. Continuous Improvement: Insights from real-world use drive design enhancements, usability improvements, and refinements to training and support, helping companies maintain competitive advantage and customer satisfaction.
  5. Market Trust: Companies that actively monitor and transparently report on product performance demonstrate a commitment to accountability, which is crucial for earning and retaining trust among clinicians, patients, and investors.

Key Methods for Effective Post-Market Surveillance

Effective in-market surveillance is multifaceted. Companies should build a strategy that draws on a mix of quantitative and qualitative data sources. Below are some of the most important approaches.

1. User Experience Monitoring

Gathering feedback directly from end-users—whether clinicians, patients, or caregivers—is essential. This can include:

  • User Surveys: Structured surveys that capture performance satisfaction/outcomes, usability challenges, and suggestions for improvement.
  • User Interviews and Focus Groups: These qualitative methods provide deeper insights into how products fit into workflows and everyday life.
  • Customer Support Logs: Analysing help desk tickets and complaints can highlight recurring issues that might otherwise go unnoticed.

2. Outcomes Data Collection

Where possible, companies should track health outcomes linked to product use. This might involve:

  • Electronic Health Record (EHR) Integration: For digital tools that interface with clinical systems, anonymised EHR data can provide evidence of impact on patient outcomes.
  • Patient-Reported Outcome Measures (PROMs): Collecting data directly from patients about their health status and quality of life.

For AI-based technologies, continuous performance monitoring against ground-truth data is particularly important to detect model drift or bias over time (Topol, 2019).

3. Performance and Safety Reporting

Systematic collection of safety and performance data should include:

  • Adverse Event Reporting: A process for recording, investigating, and reporting incidents to regulatory authorities in compliance with local rules.
  • Product Recall Systems: Plans for rapid action if serious risks are identified.

Companies should ensure they meet obligations such as the EU MDR’s vigilance reporting or the FDA’s Medical Device Reporting (MDR) requirements.

4. Peer and Clinical Reviews

Peer feedback adds an additional layer of validation:

  • Independent Studies: Encouraging independent researchers to publish findings on product performance can provide credibility and new insights.

5. Digital Monitoring and IoT

Modern health tech products, especially connected devices and wearables, can include built-in telemetry to capture usage data automatically. While privacy and data security must be rigorously protected under frameworks like GDPR or HIPAA, anonymised usage patterns can reveal valuable trends about how products are used in real-world situations.

Best Practices for a Robust Surveillance Program

To maximise the value of in-market surveillance, health tech companies should follow these principles:

  • Plan Early: Surveillance plans should be defined during product development, not as an afterthought. The EU MDR, for example, requires a Post-Market Surveillance Plan (PMSP) as part of the technical documentation.
  • Engage Stakeholders: Effective PMS involves collaboration across departments—clinical, regulatory, quality, marketing, and support teams all have a role to play.
  • Use Technology: Dedicated PMS software platforms can automate data collection, analysis, and reporting, saving time and improving accuracy.
  • Close the Loop: Surveillance is only useful if insights lead to action. Ensure feedback informs product updates, user training, or revised clinical guidance.
  • Communicate Transparently: Regulators, clinicians, and patients should know that your company takes post-market data seriously. Clear, regular updates build confidence.

The Bottom Line

In-market surveillance is not just a regulatory checkbox—it is a vital component of responsible innovation in health technology. Companies that take post-market surveillance seriously protect patients, comply with regulations, reduce liability, and gain invaluable insights to fuel product improvement.

In an age of accelerating digital health adoption, the companies that will see greatest adoption and impact are those that commit to transparency, evidence, and accountability at every stage of the product lifecycle.

This article was prepared by Evid Health, specialists in health technology user intelligence – User experience research that evaluates the real-world performance + value + impact of health technologies.

This content was created with the assistance of AI tools. However, it has undergone thorough human review, editing, and approval to ensure its accuracy, coherence, and quality. While AI technology played a role in its creation, the final version reflects the expertise and judgment of our human editors.