As drugs and medical devices continue to evolve and develop, post-marketing surveillance (PMS) has been a critical activity deemed necessary and regulated by the U.S. Food and Drug Administration (FDA) and the European Commission (EC), to assess long-term safety and efficacy of the medical product.

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Post-marketing surveillance refers to the monitoring of medical products (therapies and devices) safety and efficacy, following the market release of the product, by collecting information from healthcare professionals, patients, and regulatory bodies. It helps identify adverse events, determine efficacy patterns, and assess long-term effects, which subsequently helps inform risk assessment, regulatory response, and labeling modifications or further research.

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However, challenges related to optimizing post-marketing surveillance and obtaining new information on clinical efficacy and long-term assessment still exist. To tackle this, real-world data (RWD) has become indispensable, offering greater insights into a product’s safety and effectiveness. RWD provides real-time robust evidence for the performance and safety of a product in comparison to other marketed treatments. And the robustness of the underlying real-world data allows for the refinement of clinical, marketing, and pricing strategies across multiple products.

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Real-world imaging data (RWiD) further enhances this by adding objective, visual evidence of a product’s effect on disease progression and treatment outcomes. RWiD also provides quantifiable imaging biomarkers that allow tracking subtle changes over time and enhance the monitoring of adverse events and long-term efficacy trends.

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Value of Imaging in Post-Market Surveillance

Imaging plays a significant role in post-market surveillance for therapies and devices. Imaging for post-market monitoring of drugs helps identify early evidence of adverse effects, including structural or functional alterations in tissues/organs secondary to drug toxicity, before clinical symptoms become apparent.

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Longitudinal imaging enables the measurement of a drug's effect over a period of time, tracking its efficacy and safety in a real-world setting. Additionally, imaging biomarkers give quantitative information about drug response that provides information about the effectiveness of the treatment.

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In the context of medical devices, imaging is essential for post-market surveillance in the way that it offers objective, high-resolution information on their performance over time. In contrast to clinical experience and subjective patient-reported outcomes, imaging provides visual confirmation of device placement, function, and long-term impact on adjacent tissues. This allows for ongoing monitoring, enabling early detection of complications and ensuring the device is safe and effective. 

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Value of RWiD in Post-Market Surveillance

The evaluation of medical products after market release remains an essential process to guarantee their safety and effectiveness in real-world settings beyond trials. RWiD improves this method through visual verification while delivering profound insights and evidence regarding the medical product in the following ways:

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1. Enhanced safety and early risk detection

Conventional reporting is often based on clinician observations and patient-reported outcomes which may fail to detect subtle, early-stage complications related to novel treatments or medical devices. RWiD supports post-market surveillance by offering high-resolution, visual monitoring of biological changes over time. Identifying these risks earlier, RWiD enables preemptive intervention, risk reduction, and enhanced patient safety, in the long run, resulting in better long-term treatment outcomes.

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2. Comprehensive effectiveness assessment

By integrating RWiD with other RWD, clinicians and researchers can more effectively understand the effect of a therapy on both target organs and surrounding tissues. RWiD also improves longitudinal surveillance of disease development or remission, helping with verification of whether a treatment is indeed effective or secondary unwanted effects are occurring. This integrated strategy supports data-driven decision-making, enables regulatory evaluation, and offers potential labeling updates and support for further research.

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3. Improved performance monitoring

Evaluating long-term performance of medical devices typically depends on clinical experience and patient-reported measures, which can be subjective and qualitative. RWiD provides objective, high-resolution visual validation of how a device performs. It enables monitoring device placement, functionality, and long-term impact on surrounding tissues. Through the identification of early adverse reactions, RWiD drives data-informed improvements, preventive safety actions, and regulatory actions—ultimately improving device performance and patient safety.

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Segmed’s Role in Supporting Post-Market Surveillance 

With unparalleled visual insights that help ensure the safety of patients, treatment effectiveness, and the performance of medical products, RWiD has now become an integral part of post-market surveillance. RWiD provides high-resolution, objective evidence of risk, allowing for earlier detection, comprehensive therapy assessment, and improved long-term monitoring of medical interventions. 

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With healthcare constantly evolving, ensuring effective post-market surveillance through RWiD integration will enable informed decision making while also supporting regulatory compliance, eventually leading to the development of a safer and more effective medical innovation.

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At Segmed, we deliver high-quality, regulatory-grade RWiD designed to enhance post-market surveillance. Our RWiD offer high-quality real-world evidence to effectively monitor drugs and medical devices post-market release.

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By providing quantitative and objective data, these datasets ensure early identification of adverse events, comprehensive assessment of product performance across diverse patient populations outside of clinical trials, and greater regulatory compliance through strong real-world evidence. These datasets also facilitate product optimization to deliver better patient outcomes.

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Connect with us to explore how our diverse, high-quality tokenized imaging datasets can enhance post market surveillance, support regulatory compliance, and provide critical insights to optimize the safety and performance of your drugs and medical devices.

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