Another benefit to PMS would be the continuous documentation of potential risks that may apply to similar devices or devices that aim to solve similar health issues. The monitoring of devices ensures that no other customers will experience any harm or be put in a hazardous situation. PMS is beneficial when it comes to combination devices that involve pharmaceuticals in medical devices. In this case, your not only checking up on the functionality and usage of the device but the effectiveness of the molecular product in the patient or consumer as well
The point of post market surveillance is to maintain a product quality as well as its performance. Despite the fact that in the United States it is a regulatory requirement, it allows you to improve your device for a future version and ultimately minimize adverse risks or events that may take place. The PMS can be a review of the experiences of the end-user post a launch of the product and allow the company to take any necessary corrective or preventative actions post the launch. An important aspect of this process is the collection of data and allows for studies to be conducted especially on high risk medical devices. In real life scenario, a very well-known medical device company is now in the process of a product recall because one of the parts related to the device was known to be a carcinogen and as a result, the product is being recalled across the United States including those products that were part of contractual agreements with the federal government. The PMS makes it so the corrective action of this magnitude can be implemented given the risks associated with the continued use of this device.
Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.The primary purpose for conducting post marketing surveillance is to identify previously unrecognized adverse effects as well as positive effects. Post marketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. This is important to do this because it minimizing the risk and provides communication of the device to key people of adverse reactions.
Sources:
Raj, N., Fernandes, S., Charyulu, N. R., Dubey, A., G S, R., & Hebbar, S. (2019). Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada. Therapeutic advances in drug safety, 10, 2042098619865413. https://doi.org/10.1177/2042098619865413
To make sure medical devices remain safe and effective once it’s on the market - medical post-market surveillance (PMS) is done. It a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality.
PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behavior and clinical outcomes. The need for PMS arises immediately upon commercialization of the device.
Implementing an ongoing PMS investigation lets manufacturers quickly identify any needed improvements. Other benefits include lower complaint costs due to fewer incidents, and greater customer loyalty and engagement.
What are the other benefits of post-market surveillance?
The benefits of post market surveillance include being able see large scale effects of your product. You get to collect data on side effects that may not have been seen in trials, may even get to see benefits that were not expected. It also help ensure the safe of the product and get feedback if adjustments are needed.
Post-market surveillance serves an important purpose. Even though medical devices go through rigorous testing pre-market, some adverse events could pass through this phase unnoticed. Post-market surveillance allows for the monitoring of medical devices after they have hit the market. There are many ways medical devices can be monitored in the post market including spontaneous reporting databases, electronic health records, patient registries, and record linkage between health databases.
To make sure medical devices remain safe and effective once it’s on the market - medical post-market surveillance (PMS) is done. It a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality.
PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behavior and clinical outcomes. The need for PMS arises immediately upon commercialization of the device.
Implementing an ongoing PMS investigation lets manufacturers quickly identify any needed improvements. Other benefits include lower complaint costs due to fewer incidents, and greater customer loyalty and engagement.
What are the other benefits of post-market surveillance?
I think PMS is essential for medical device companies. One huge benefit of PMS is the ability to put a microscope to any product failures and identify trends if they are present. This allows for an investigation, as you mentioned. But even taking that a step further, it acts as a safeguard to ensure that all components and the design are working effectively for the product to work. This is almost a secondary validation, a real test if a product is meeting true customer needs. Another great aspect of PMS is that is a product change is made, for cost purposes for example, PMS will be the first to know if that change leads to an increase/decrease in product complaints. Again, this is a real-world test to determine if things are going according to plan and is a vital aspect of medical device companies for ensuring long term success of a product and patient safety.
Thanks,
Matt
Having worked in PMS myself, I can also add that the information collected by the department is often heavily leveraged for regulatory requests as well. Many times regulatory authorities will request information on product complaints to assess its efficacy and determine if it passes regulatory requirements to continue to be sold in those countries. Although it is a quality department, it works very closely with others including new product development and regulatory teams.
Post-market surveillance seems to be a great way at determining how well a product is received, further determining user needs and inputs. The process may even contribute towards design validation even after design controls cease. PMS is also a useful tool to determine if the product is profitable for the company. The only detriment to PMS that I would claim is how difficult and costly it may be for manufacturing to implement the changes reported from PMS, but nonetheless it is necessary in order to retain customer loyalty and mitigate risk.
The sole function of PMS, is for tracking and reporting malfunctions. Its to identify and gaps or holes in the overall manufacturing process, or quality process in general. Post-market survillance is not mandated by FDA, however it is a tool that is used to enhance the overall quality. PMS allows companies to have a better record of how their product is performing in the market compared to others. PMS can also provide insight for next generation products.
The sole function of PMS, is for tracking and reporting malfunctions. Its to identify and gaps or holes in the overall manufacturing process, or quality process in general. Post-market survillance is not mandated by FDA, however it is a tool that is used to enhance the overall quality. PMS allows companies to have a better record of how their product is performing in the market compared to others. PMS can also provide insight for next generation products.
Post market surveillance is absolutely a good thing for a company to do after releasing the product. By watching how the product performs a company can come to the conclusion of what the next generation of product needs to include. Such as if the rate of infection increases by releasing the product, the company can know that the next generation has to include some compound that would mitigate the risk of infection. Also a business can see how well a product is performing in a business standpoint and and can do customer outreach to see what can be fixed for a better product which can in turn return a better profit. And since the purpose of a business is to make money, the objective would be completed. The other benefit that can be seen often seen in tech companies is to gauge customer needs and wants and releases the next generation with those features.
Post market surveillance is critical to ensure that devices are continuously operating in a safe and effective manner throughout the entire product life. Post market surveillance may identify risks that were previously unrecognized. By identifying such risks, medical device companies can take the necessary measures to create a safer device. Additionally, a lot of regulators around the world require post market surveillance to be reported even if an incidence occurs in a different market. Therefore, post market surveillance monitoring is critical to maintain compliance. For example, Canada recently updated one of their regulations to expand the scope of post market surveillance reporting. Based on the new update, if a medical device company has a product sold in Canada and China, but an adverse event occurs in China, it is still required to report it to Health Canada in some cases.
Post-market surveillance is very beneficial as it allows companies to see the long term results of their product as well as how they affect the consumer in their daily life. Post data can offer valuable information that can show whether the product was a success or failure, helpful or detrimental to the customer. Many companies use post market surveillance, esp in technology, pharmaceutical, and mechanical industries. This is especially important in the medical field as it allows the results of the product to be shared as well as monitor the device and make sure it is operating accordingly.
Medical device startups and manufacturers should take the PMS process as a holistic approach to maximize the gains including fewer medical device defects, improved user safety, and, in certain cases, decreased litigation risks. The essential tools of your PMS process are proactive/reactive PMS and vigilance. When a medical device developer/manufacturer realizes that a PMS system is a quality control process for their medical device rather than just a regulatory requirement. Proper implementation of the PMS is an integral and key component of a medical device’s success and PMS implementation procedures should reflect your commitment to data collection, review, and implementation. A vigilant system can also help in deciding if any corrective and preventive actions (CAPAs) are necessary to resolve the problems with your device, via product design or manufacturing changes, root cause resolutions, product labeling, and/or training to prevent future occurrence, etc. Additionally, the data gathered through the vigilant system can be channeled into documents such as the Risk Management File and Clinical Evaluation Report (CER). These new data from a vigilant system might help in identifying further risks that were not previously documented, as well as demonstrate if the risks are still within the acceptable range.
Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the market, and to identify the need to take any action. Post-market surveillance is a crucial tool to ensure that medical devices continue to be safe and well-performing and to ensure actions are undertaken if the risk of continued use of the medical device outweighs the benefit. The evaluation of post-market surveillance experiences can also highlight opportunities to improve the medical device. It describes the measures taken to ensure the ongoing compliance of medical devices with the requirements for safety, quality, and performance after they are placed on the market. The PMS data can give manufacturers of safe medical devices a clear-cut competitive advantage over any unsafe devices that may be on the market. Moving forward, it will be significantly harder to maintain healthcare approval if the safety and performance of a device cannot be continuously validated in real life environments. Furthermore, with easy access to information, healthcare professionals and consumers are making informed choices based on references, data and reviews. Therefore, it is likely that healthcare actors (and consumers) will choose medical devices that have the necessary evidence to support their claims, which will positively affect sales and the success of these devices. Thus, the outcome of Post-Market (Marketing) Surveillance of medical devices may be positive for both the industry and the public in the long term, and should be embraced rather than questioned. A couple of years ago, a European breast implant manufacturer was sanctioned for selling non-medical grade implants. It created a global health scare. More than 30.000 women were recommended to remove their implants and many suffered serious health problems and even death. It is believed that this case was one of the main drivers behind the increased focus on PMS in the MDR - and it might have been. However, if you look at the size of the industry and the number of devices available, the risk of a similar case re-occurring is significant. I found a Netflix documentary, called "The Bleeding Edge", where a filmmaker examines exactly this. The film reveals disturbing cases where people have endured serious health issues that are thought to be linked to various medical devices. The validity of the information presented in the film can be discussed, but the message that it delivers is strong. The film touches upon different aspects of the regulatory framework. But its focus is on the market approval process and the lack of data used to support clinical efficacy and safety.
