Post-market surveillance is now required by the FDA. Med device companies must have tracking systems in place, report medical device malfunctions, injuries and deaths, and register where the devices are being built. By conducting post-market surveillance, medical device companies will have a better record of how their product is performing in the market. This can also benefit them in created the next generation of the medical device because it can address issues that came up with the current device and provide more evidence for safety of the device when claiming "substantial equivalence" for a pre-market notification.    

Like in the lecture the risk management process should be designed in a way where it starts at the very beginning of the project to the end of when the product's life ends. Especially for medical products. PMS I think is very important for newer devices or Class II or higher. Since these devices tend to contain new technology where all of the risks can not be covered during the design phase. In addition, in order to prove that these devices are safe, there has to be numerous data to support the safety of the product. And by having a robust PMS system the company should be able to effectively collect data. In addition, these systems should be able to save time and find risks when it is started to manifest rather than after it does. 

Post-Market surveillance is important for medical devices of all classifications, and additionally all products in general. This goes back to the statement that risk management does not have a specific timeline, because it should be performed in conjunction with every task from the start to the end of the product life-cycle. Getting to market is not the end of a products life-cycle. Once a product is available to consumers, it might be the most important time for very in depth risk surveillance because any issue with the device can have an immediate consequence for consumers. Not only could this harm the consumer, but any major problem with the device once on market could be completely catastrophic for the company. Whereas, if proper post-market surveillance is performed, this hypothetical dangerous problem with the device could be identified and fixed through a recall before any serious damage is done.

Besides the already stated benefits of lower complaint costs, better product reliability and higher customer satisfaction, post-market surveillance (PMS) is a process that drives long-term product sustainability, from both a manufacturing and customer relationship standpoint.  In many ways, sustainability is a greater challenge than introducing a new medical device to market.  PMS is likely to be more valuable to medical device company stockholders than even to customers; product longevity is good for stockholder earnings. Strong post-market surveillance also has a direct correlation to product design improvements.  Plus, a continually improving product gains the confidence of the investors, so a medical device company would have an easier time securing new investor funds if it was considering an elaborate product expansion to gain more market share or to distance itself from competitors. 

My perspective is that Post Market Surveillance is where the rubber its the road. With all the efforts of design engineering and the design controls, in some situations, it is only when we really have the medical device used in the field do we really understand issues from a technical perspective or how it is used. Even in clinical studies, we are using a small sample of patients to predict outcomes in the large population. 

The interesting thing is that end users such as physicians, healthcare providers or patients seem to interact with the medical device in ways we may not have predicted. We need to be open to collecting that feedback and react appropriately. Obviously, firms do not want to change the product significantly or have issues once the product is in the market, however, the reputation of the firm will be gauged in how they handle these difficult situations. We need to remember patients come first....

Post-market surveillance is important because it reveals more about product safety and effectiveness that could not be learned during clinical trials. It also monitor products' performance in the field, detecting product faults, and help initiating necessary measures such as recalls for the product if needed.

Another benefit of Post-market surveillance is that it protects patients. While it may save the company money and help the company make easy improvements to their devices as necessary, ultimately Post-market surveillance provides a mechanism by which a product is constantly being monitored and thus ensured that its safety is maintained. Clinical trials are one thing, years of data from actual use can provide insights into issues that trails may have missed and thus help improve the device and make it safer. It also provides a mechanism by which products can be improved and updated as time passes. Research and medical technology is not stagnant, a device can be improved by monitoring how it behaves in the market and how its competitors behave as well. 

Another benefit of post-market surveillance is determining whether preventive actions from risk management processes have been effective. This can be done by simply reviewing the risk register along with data from the post-market surveillance and observing the frequency and impact of each item. Comparing the risk register’s predicted data with the actual data from post-market surveillance can identify which processes were successful and which processes were not successful. This information can be used to adjust risk management processes for the current project, but more importantly, it can be used to prevent risk management inefficiencies in future projects.

I agree that it is important to continue to keep a product or device under surveillance even after it is already on the market. Hopefully, it is not required, but sometimes recalls may be necessary if potential risks that were not accounted for arise. PMS can be representative of long-term success and safety of products as it looks at how a product is doing once on the market. Personally, I immediately think of the consumer feedback. With proper PMS, any issues that arise can be handled and consumers can stay satisfied with products and the companies that created the products. Specifically, for the medical device industry, consumers include both patients as well as doctors, and continued support from these consumers are vital. Lastly, if a product can be adjusted and released with a newer version, it would be important to understand the feedback and input obtained through PMS. These inputs could be implemented into the newer version which would make the company look good, earn more profit, and keep, if not gain, consumers in some cases. Thus, there are plenty of benefits in conducting PMS for not just medical devices, but for medical device companies as well.

Other benefits of PMS is to monitor a device for its safety, quality and effectiveness throughout its entire lifetime. This gathers data about the device and helps in further research and prevention of certain risks in the future. This gives manufacturers the ability to continuously update the risk assessments associated with the device and avoiding delays in initiating necessary measures to stop/fix or prevent a harm.

Like many of you stated, post-market risk management is extremely important for any device, biologic, or any invention for that matter. It assures longevity of the device and evaluates risks that may not have been seen during planning, design, fabrication, or clinical trials. It is also a useful way to track the efficacy of the device as time passes, and if shown to be effective with longevity, there it can be used as a marketing strategy for continuous sales. Moreover, post-market risk assessment, whether positive or negative can be used for future device development and design input for future devices. 

I think PMS is very important for newer devices or those of Class II or higher because these devices tend to be of newer technology where all of the risks can not be covered during the design phase. In order to prove that these devices are safe, there also has to be numerous data to support the safety of the product. And by having a robust PMS system the company should be able to effectively collect data. In addition, these systems should be able to save time and find risks at the beginning rather than after the damage is done. With proper PMS, any issues that arise can be handled and consumers can stay satisfied with products and the companies that created the products. Another benefit of post-market surveillance is determining whether preventive actions from risk management processes have been effective which can be done by simply reviewing the risk register along with data from PMS and observing the frequency and impact of each item. 

Posted by: @sallirab

Post-market surveillance is important because it reveals more about product safety and effectiveness that could not be learned during clinical trials. It also monitor products' performance in the field, detecting product faults, and help initiating necessary measures such as recalls for the product if needed.

 

Post market surveillance is also a great to gauge the needs of the public. Any updates that need to be made to the product or preference pattern can be recorded and analyzed through this process. In fact it might help reveal tactics that a company can use to generate increased percentages of profit and new customers. 

Post market surveillance is the requirement that medical devices have to continue to be monitored after they have been cleared for sale and placed on the consumer market for purchase.  It is a very important factor because it demonstrates the real world safety and effectiveness of medical devices. One of the primary responsibilities of post market surveillance functions to detect manufacturing problems. Other functions include: the improvement of device quality, it provides verification that a risk analysis has been conducted, as well as you can track and produce trends for the data of the medical device.