|
A significant segment of the IoT ecosystem, the Internet of Medical Things (IoMT), is projected to grow at a compounded annual growth rate of 23.7 percent (forecast period: 2022-2032). This fast growth is indicative of how rapidly IoTM is integrating into modern society, which has understandably attracted the attention of regulators.
The widespread use of IoTM devices means that their malfunction or dysfunction can affect the health and lives of many. It makes sense to subject them to rigorous regulation to make sure that they perform their functions effectively and safely. Device manufacturers, distributors, or resellers cannot simply sell their products and forget. They have the responsibility to monitor the performance, identify potential risks, and ensure the continued safety and effectiveness of the IoMT devices they offer.
Many businesses understand the importance of post-market surveillance for IoMT. Unfortunately, not many voluntarily do it. It can be a tedious and costly process, after all. The systematic collection, analysis, and evaluation of data involving medical devices that have already been sold to users or deployed in various healthcare settings entail additional human resources and technical costs. Businesses always seek to maximize profits and minimize expenses.
However, here are three of the most compelling reasons why businesses should consider post-market surveillance as a vital component of their ongoing product lifecycle management.
Post-market surveillance for IoMT products hinges on four key objectives: early detection of device issues, long-term device performance evaluation, device-user interaction monitoring, and the identification of emerging risks. Not every business that conducts PMS uses the same processes, but their actions are generally guided by these fundamental goals.
Good post-market surveillance starts with robust data collection and analysis. To get the most value out of it, organizations should develop a systematic way of gathering data and preparing them for advanced analytics. All the important details should be obtained, including the adverse events, usage frequency, user behavior, and user feedback. When it comes to data analysis, it helps to employ advanced data analysis techniques such as statistical analysis, data mining, and AI-powered data correlation.
In addition to robust data gathering and analysis, it is also important to have active collaboration. Post-market surveillance cannot be solely entrusted to a single team or a few personnel. There should also be active communication and collaboration with healthcare providers, regulators, and stakeholders to ensure data accuracy, more informed insights, and prompt response to safety concerns.
Moreover, it helps if organizations were to enforce proactive risk management. There are useful risk management frameworks like the International Organization for Standardization (ISO) 14971, which can guide the process of examining and mitigating risks. These frameworks are particularly useful to those who have limited know-how or experience with effective post-market surveillance.
It is also essential to emphasize the monitoring of the real-world performance of IoMT devices. This is done through post-market clinical follow-up studies, which entail the monitoring of device performance, efficacy, and safety as they are used in uncontrolled real-world situations. This helps verify clinical outcomes, detect problems, as well as collect information that may serve as proof that the existing system employed by the manufacturer is adequate to ensure product efficacy and safety.
Lastly, post-market surveillance should enforce policies for timely reporting and regulatory compliance. This involves a lot of paperwork or documentation, which everyone should accept as inevitable and vital to get the full benefits of doing post-market surveillance.
Post-market surveillance is not as easy as it sounds. It can be quite challenging given the enormity of the data collection and management involved and the need for in-field visibility brought about by the use of gated and isolated devices. Many encounter confusion as to what data to collect and how to proceed with the assessment. Some have a hard time gaining real-time visibility over devices that are not always online and those characterized as isolated or gated.
These challenges are far from insurmountable, though. Some organizations build DIY systems to ensure comprehensive data collection and management and gain real-time visibility over devices. These can be quite costly, though. Nevertheless, there are products designed for IoMT post-market surveillance to efficiently collect relevant data, ensure visibility, and provide deterministic security to address known and unknown threats.
It is important to get post-market surveillance right to make sure that it leads to user safety, consistent product quality, and improvements. This is the kind of surveillance regulators encourage and consumers approve. It can lead to more costs for device manufacturers and sellers, but it is necessary to ascertain product quality and user safety. Also, proper post-market surveillance helps organizations avoid entanglements with regulators and help expand business prospects while gaining consumer trust.
Sponsored byCSC
Sponsored byDNIB.com
Sponsored byRadix
Sponsored byWhoisXML API
Sponsored byVerisign
Sponsored byIPv4.Global
Sponsored byVerisign