Post market surveillance (PMS), a regulatory requirement for many medical device companies, that distribute their products within the market of the European union. Among many obligations, the regulation requires a post market surveillance process and plan, that should provide continuous feedback regarding a device on the market according to MDR article 84 and further described in Annex III, section 1.1 Noticeable is that, besides monitoring vigilance and trends of such, companies also must “address the collection and utilization of available information, in particular:
Relevant specialist or technical literature, databases and/or registers.
Information, including feedbacks and complaints, provided by users, distributors and importers.
Publicly available information about similar medical devices.
To do so, companies will need to monitor several digital sources to stay updated, keep track of regulatory changes and updates and follow their own and your competitors' products. We call it content monitoring, i.e. to monitor sources and content to infinity and collect this information.
When performed correctly, the results from post market surveillance will generate great assets of information that will not only make a company compliant, it will also support continuous improvements of a device, in both quality and for further innovation and product development. Post market surveillance is a challenging process and task. It takes a lot of time and resources to get it done right and it is hard to find an effective process of finding, storing and reporting the content and information that is needed.
We have gathered our best tips and tricks on how to reach a more systematic and effective post market surveillance process.
Many sources to monitor and information to be compiled First of all, there are several sources to keep track of. From databases and news media, to social channels and forums. According to the regulation, MDR article 84, companies shall perform surveillance of their products to report vigilance, trends, literature and feedback (positive and negative). This means that sources such as Pubmed, FDA Maude, Legal Health Authorities (Countries and regions), Clinical Trials, nisch media and expert media for technology insights, and also social media for unsolicited reporting and feedback must be monitored and screened for “mentions” of the own product and core technology related to the product. The first part of the time-consuming process of post-market surveillance is to keep track of every source - a couple of times per year to compile the PMS report, and much more often to really benefit from market information and make the insights actionable.
Our first tip is to divide the sources into different groups. One for vigilance and trends, one for literature (technology and science) , one for unsolicited reports and feedback (social media, forums, and nisch media), one for state of the art technology and one for state of the art regulatory intelligence . In Hoodin, the automated content monitoring system, all sources are presented in such a way that it is very easy to find the most relevant sources to monitor, and recommended sources to use for a specific need.
Dealing with a high amount of digital content Every day, a huge amount of content is being published online and the frequency makes it impossible to keep up with high volume. Doing all this manually will get extremely time consuming and also very hard to perform at a high quality level.
Why don’t let an automated system do it instead? This must be the most valuable tip, where the change to let manually repeated searches become replaced with an automated system that will save you hundreds of hours per year! You and your team will instead focus on the results and insights instead and transform gathered information from your Post Market Surveillance to actionable insights.
Content and information that you can identify and collect automatically via Hoodin:
Clinical trials
Incident reports / Adverse events / Recalls
Scientific literature
Social media posts
Case studies
Regulatory changes and updates
Patents And more
Collect the information, and then what?
Step number three of the Post-market surveillance process is the reporting and sharing phase Which includes information and extracting the most relevant parts. To collect the information is one thing, but then you actually might need to take some action. Many teams and organizations don’t really have a process for this, therefore, we wanted to make sure that you can run both step 1 and 2 from the Hoodin platform. Monitor sources, collect data and then share the insights and create reports on the results. In Hoodin you can easily invite colleagues to your Hoodin project so that they can take part in your findings. Why not include the whole team and share the different findings with the right person and avoid that peers are performing the same research without knowing?
So, our last and third tips must be: don’t make your organization's post market surveillance process into a one person's job (definitely not manually). This should be a systematic process that includes the whole team, so that you can continue developing your products and services in a better and smarter way together. So focus on that, and let Hoodin do the “boring” part, to collect all that data.
Client case - Syntach uses Hoodin for post market surveillence
To learn more about Hoodin for Medtech and Post market surveillance, book a meeting here.