When it comes to medical device development, post-market surveillance is often treated as a box to check after launch. But in today’s regulatory and clinical landscape, that mindset can cost you, both in compliance risk and missed opportunities for product improvement.
Building post-market surveillance capabilities like remote monitoring, automated error reporting, and usage analytics directly into your device software from day one isn’t just smart, it’s essential.
In this article, we’ll explore how embedding post-market surveillance capabilities early leads to safer, smarter, and more successful products.
What is Post-Market Surveillance and Why It Requires Early Consideration
Post-market surveillance (PMS) is the ongoing process of collecting, analyzing, and acting on data about a medical device after it has been released to the market. Its purpose is to ensure that devices continue to perform safely and effectively in real-world settings, capturing insights that may not surface during pre-market testing.
Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (under the EU Medical Device Regulation) mandate robust PMS systems as part of a manufacturer’s overall compliance strategy. Under EU MDR in particular, PMS is no longer a passive, optional activity—it’s a proactive obligation that must be built into the device lifecycle from the outset.
These regulatory drivers have transformed PMS from a back-end process into a critical design consideration. For medical device developers, this shift means that the systems, software, and infrastructure needed to support PMS must be anticipated—and built—long before a product reaches the market.
Common Misconceptions
Despite its growing importance, PMS is still commonly misunderstood, especially by developers newer to the medical device space. One major misconception is that PMS is purely reactive—something handled by the quality or regulatory team only after devices are in the field. In reality, PMS is most effective when it’s proactive, using real-time data and connected software to flag issues early and inform product updates.
Another misconception is that PMS capabilities can simply be added later in development or layered on post-launch. While some monitoring tools can be retrofitted, this often leads to incomplete data, delayed insights, and increased compliance risk. Effective PMS requires architectural planning, particularly regarding data flow, remote connectivity, and system integration.
Finally, too many connected device developers assume that PMS is purely a regulatory burden, overlooking the strategic value it offers. When thoughtfully implemented, PMS becomes a competitive advantage—enabling continuous product improvement, better patient outcomes, and deeper user insights.
Benefits of Considering PMS Early On
Integrating PMS planning into early-stage software and system design doesn’t just help meet regulatory requirements, it builds a foundation for product resilience, faster iteration, and long-term market success. By embedding PMS capabilities from day one, developers can:
- Ensure compliance from the start, aligning with FDA, EU MDR, and ISO 20416:2020 expectations for proactive surveillance.
- Improve patient safety through real-time monitoring and faster identification of device malfunctions or risks.
- Enable rapid, data-driven decision-making by capturing usage and performance insights in the field.
- Reduce the cost of late-stage changes by avoiding rework or patches needed to add monitoring features later.
- Support continuous improvement via integrated feedback loops that inform software updates and product refinements.
- Gain a competitive edge by demonstrating transparency, responsiveness, and long-term device support to clinicians and regulators.
Early PMS thinking isn’t just about checking boxes—it’s about building smarter, safer, and more future-ready devices from the ground up.
Key Software Features That Enable Built-in PMS
Building effective post-market surveillance into a medical device is about more than just the data you collect. It’s about how your software is designed to support ongoing monitoring, reporting, and improvement.
When PMS is considered from the start, your software can do much more than function—it can actively contribute to patient safety, regulatory compliance, and long-term product success.
Below are the core software features that enable this level of integration.
Remote Monitoring
Remote monitoring is the foundation of proactive PMS. By capturing real-time data from connected devices, developers and clinical teams can continuously assess device performance and patient outcomes in the field.
This feature allows for:
- Continuous collection of performance and physiological data
- Real-time alerts for out-of-spec behavior or safety risks
- Monitoring of adherence and proper device usage
When integrated with cloud infrastructure, remote monitoring enables scalable oversight across patient populations, making it possible to detect early signs of failure or risk trends before they escalate into recalls or adverse events.
Automated Error and Event Reporting
An essential PMS function is the ability to automatically log, classify, and report device errors, anomalies, and adverse events. This goes far beyond basic crash logs. It requires structured, context-aware data capture that feeds directly into your quality management and regulatory systems.
Effective implementation supports:
- Systematic logging of failures and unexpected behavior
- Severity classification and alert thresholds
- Seamless integration with QMS for complaint handling and field corrective actions
- Pre-configured pathways for regulatory reporting
By automating this process, your device doesn’t just capture data but becomes an active participant in risk management and compliance.
Usage Analytics
Beyond safety and malfunction data, usage analytics provide a window into how devices are used in the real world. This includes user behavior, frequency of use, time-on-task, and interaction patterns—all of which can influence safety, efficacy, and future design improvements.
These insights help:
- Identify trends in off-label or unintended use
- Detect training gaps or usability issues
- Support the design of next-generation features based on real-world behavior
With proper anonymization and consent protocols, usage data can also inform broader clinical research and business strategy.
Over-the-Air Updates
Post-launch updates are inevitable. The ability to deploy them securely and efficiently is a powerful PMS enabler. Over-the-air (OTA) updates allow developers to fix bugs, address safety concerns, and enhance functionality without requiring device recall or manual intervention.
Key benefits include:
- Swift deployment of safety-critical patches
- Continuous improvement without disrupting patient care
- Reduced burden on technical support and service teams
- Compliance with cybersecurity and software lifecycle requirements
OTA capabilities must be built with robust version control, rollback mechanisms, and validation pipelines to ensure safe and compliant updates in the field.
Secure Data Infrastructure
All of these features depend on a data infrastructure that is both secure and compliant. Medical devices must protect patient data while ensuring system integrity, especially when transmitting health data over public networks.
A compliant, PMS-ready infrastructure includes:
- End-to-end encryption of data at rest and in transit
- Access control and audit logging
- Support for HIPAA, GDPR, and other regional privacy frameworks
- Scalable architecture for long-term data storage and traceability
Security isn’t just about protecting data. It’s about protecting trust, regulatory standing, and the safety of your users.
How to Design for PMS from the Start
Designing for post-market surveillance requires a foundation that supports ongoing performance tracking, user feedback, and compliance from the very beginning.
By intentionally integrating PMS considerations into your system architecture, development processes, and cross-functional planning, you create a device that’s smarter, safer, and ready to evolve. Here’s how to do it.
Start with a Risk-Based Mindset
The first step in designing for PMS is aligning it with your risk management process. Under ISO 14971, risk management should guide decisions throughout the product lifecycle. PMS is one of the key feedback loops that keeps this process alive after launch.
From the earliest design phases, ask:
- What potential risks could emerge in the field that won’t be captured during testing?
- What data would help us detect those risks early?
- How should we structure our software to monitor and respond to those signals?
By defining these risk-informed data needs early, you can design sensors, software, and analytics pipelines that capture meaningful information rather than just noise.
Build a Feedback Loop into Your System Architecture
A successful PMS strategy depends on creating closed feedback loops that connect data from the field back to the teams that can act on it. This requires thoughtful system architecture that integrates the device, cloud services, data analytics, and internal quality systems.
At a high level, this loop should look like:
Device → Cloud → QMS/Analytics → Engineering & Quality → Field Action
To support this loop, your architecture should enable:
- Real-time or periodic transmission of structured data
- Secure data storage with traceability and version control
- APIs or pipelines that feed directly into complaint handling and quality systems
- Dashboards or alerts that notify relevant teams when thresholds are crossed
Designing these pathways early ensures your team can act on the data they collect.
Collaborate Across Functions
PMS cannot be designed in a vacuum. It requires input from clinical, regulatory, quality, engineering, and even commercial teams to determine what matters most in the field and how to capture it.
Key collaboration points include:
- Regulatory & Quality: Define reportable events, risk thresholds, and QMS integration needs.
- Engineering: Determine what system-level metrics can be realistically captured and transmitted.
- Clinical & Product: Identify what usage or outcomes data would inform improvements or support claims.
- Customer Support: Understand what users report most often and how PMS data could preempt service calls.
Embedding cross-functional perspectives ensures that your PMS features are technically feasible and strategically valuable.
Plan for Scalability and Change
Finally, keep in mind that PMS needs—and regulatory expectations—will evolve. Your system should be built for adaptability. This means:
- Designing modular software components that can be updated independently
- Building data schemas that support new parameters over time
- Structuring your cloud infrastructure to scale with your user base
- Incorporating OTA update capabilities to keep your device software current and secure
Thinking beyond launch helps future-proof your PMS strategy and your product.
Build a Smarter Device by Building in PMS from the Start
As regulatory expectations rise and connected devices become more complex, embedding PMS capabilities like remote monitoring, automated reporting, and real-world analytics from day one sets your product up for success.
By understanding what PMS is, dispelling common misconceptions, and leveraging the right software features and architectural decisions early, you can ensure your device is not only compliant, but resilient, responsive, and ready for continuous improvement.
At Sequenex, we specialize in helping medical device companies build software with post-market surveillance in mind from the very start. Our development processes and customizable NEX Platform are designed to support connected, compliant, and future-ready devices. Whether you’re in the concept phase or preparing for market, we can help you embed the features and infrastructure needed to monitor and evolve your product in the field. Connect with us today to learn more.
