Post Market Surveillance (PMS) is one of the life cycle components for medical devices. While pre-market testing evaluates the device to ensure that it meets certain regulatory standards before being released into the market, PMS focuses on following the device’s performance after coming on the open market.

The real-time data collection on how medical devices are performing under realistic conditions brings several insights into their safety, efficacy, and overall quality. Using the PMS findings, manufacturers and regulatory bodies keep track of adverse events, identify potential hazards, and ensure compliance with safety standards.

It implies that PMS data can significantly lead to design improvement of devices, improved patient outcomes, and a constant high level of quality of the product throughout the device lifecycle.

The importance of PMS findings and their contributions to improved quality and device design is what is articulated in this article.

The crucial advantage of PMS findings would be to discover design defects, which are not readily visible during the developmental and pre-market testing stages. These defects may have some relevance to the ergonomics, usability, functionality, or material performance of the device. They would then report the defect to the manufacturers, who are expected to take corrective actions such as redesigning, improving used materials, or altering the manufacturing process. For example, critical user feedback focuses on the usability aspects of the device, such as its complicated interface or uncomfortable designs. Thus, the manufacturers can analyse this feedback and decide on appropriate targeted changes to enhance the user experience by making the device much easier and safer to use.

It involves the actual collection and analysis of data from a medical device post-approval. This data usually comes from varied sources such as the hospital, the healthcare provider, the patient, and the users of the device. The primary aim of PMS is to detect and analyse adverse events occurring post-marketing and report any faults or malfunctions that have not been observed during the pre-marketing test. Thus, these findings are indispensable in recognizing safety problems that may threaten patients.

PMS data is very important in relation to the performance features of any device used in real-world clinical settings. Performance data during normal usage can indicate how the actual performance of the device deviated from its actual performance, as in the case of a device showing signs of wear and tear before anticipated or not delivering the intended therapeutic benefits consistently. This information will provide insights to redesign a better device from material studies or changes in the production processes employed to manufacture the device.

Safety is an extremely important parameter for any kind of medical device, and PMS findings play a key role in discovering new risks which were undiscovered during all pre-market evaluations. These events will be closely monitored. Adverse events, such as malfunctions of the device or side effects, and post-market surveillance will report on hazards and injuries.

Allowing timely improvements by manufacturers, thus enhancing safety and preventing future incidents. PMS findings can also be useful to detect trends in device usage which may indicate unanticipated safety concerns. For instance, if there is a sudden upsurge in the number of reports referencing a specific device malfunction occurring under certain conditions, that might lead manufacturers to examine the conditions and put corrective action in place.

PMS provides the essential input for design improvement and quality assurance but is also the mechanism for continued compliance with regulatory requirements. Medical device manufacturers must have continuous surveillance of their marketed devices by regulators. PMS data help manufacturers to comply with these requirements through feedback on their product’s performance in the real world.

Data gathered from PMS can often turn out to be one of the most potent catalysts for innovation and continual enhancement. These reports may capture adverse events, trend data, and changes in devices that may be necessary to attain safety compliance standards.  It gives a thorough understanding of device use under real-life scenarios and failure zones through which manufacturers can easily lay down opportunities for new features or improvements that can meet some needs which remain unfulfilled.

Post-market surveillance is an essential practice in the medical device industry, offering a wealth of information that can be used to improve device design and quality. By systematically collecting and analysing data from real-world use, manufacturers can identify design flaws, enhance device performance, improve safety, and stay compliant with regulatory requirements. Ultimately, PMS findings drive innovation and continuous improvement, leading to the development of safer, more effective, and user-friendly medical devices. As the medical device industry continues to evolve, the importance of robust PMS systems cannot be overstated, ensuring that devices meet the highest standards of quality and patient care.

REFERENCE

1. MEDDEV 2.7/7 revision 4, clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EE
2. EU MDR 2017/745
3. Medical devices-post-market surveillance for manufacturers (ISO/TR 20416:2020)
4. MEDDEV 2.12/1 Guidelines on a Medical Devices Vigilance System.