Post-market surveillance, or PMS, is an integral part of releasing medical devices safely into the market. While medical devices undergo strenuous testing before release, PMS helps manufacturers and regulators understand how these devices work in the real world, with real-world data.
While manufacturers can follow several guidelines regarding the post-market surveillance of medical devices, data handling is usually sidetracked in favor of ensuring the device meets regulatory guidelines.
For instance, manufacturers often focus on installing proactive PMS but fail to document processes or consider the proper handling of error data. Here are three data considerations every manufacturer must take into account when installing post-market surveillance of medical devices.
Secure Risk-Profile Data
Medical devices generate huge data volumes well before they hit the market. These devices are placed through rigorous pre-market surveillance that helps manufacturers pass regulatory guidelines. Securing those datasets and using them to inform PMS tactics is a critical part of ensuring the device’s release is a success.
Many medical technology companies rely on the cloud to store and distribute device data. While the cloud is a great option, companies must avoid relying solely on their cloud service provider’s security processes.
For instance, medtech companies must combine cloud service provider keys with their security keys to ensure third parties will not have unauthorized access to their data.
An API-based tool is a good choice in this context since it will connect the different portions of a company’s infrastructure, whether on-premise or cloud-based. Tools like these secure the sprawl that the average company experiences with its infrastructure.
Device manufacturers must also store pre-market surveillance data for easy reference since comparing it to PMS data will guarantee an accurate risk profile of the device. Armed with this information, companies can make the right product updates to boost sales.
As with everything connected to medical data, security is paramount. Companies must back their cybersecurity tools with the right processes for maximum efficiency, escalating security threats to the right personnel immediately.
Ensure Good Metadata Management
While medical devices generate a ton of data, few companies take the time to ensure their metadata practices are up to scratch. Metadata, or data that describes the context behind device data fields, is critical to ensuring a device’s success.
Post-market datasets can differ greatly from pre-market ones since companies do not fully know how consumers will use the device. This leads to situations where similar-looking PMS data is confused with pre-market data, causing an inaccurate risk profile.
For starters, companies must define their metadata practices and install rigid governance around them. Tagging a handful of personnel is critical. This team must be solely responsible for maintaining metadata and ensuring every dataset’s context remains preserved.
Companies must also build fail-safes for this team. For instance, if a valuable team member leaves the company or is unavailable for some reason, companies must have a backup in place. Automating metadata management usually does the trick.
An automated tool can maintain field information and flag potential issues. It can also act as a metadata wiki, giving new hires a short ramp-up time to understand what data they’re handling. As the device gains popularity in the market, dataset volumes will explode, making metadata management tricky.
Aside from new datasets, companies may find they lack the storage to process higher volumes. This situation might lead them to expand to a new server without copying metadata information over. As a result, as data volumes compound, companies lose context, and this makes error handling highly challenging.
The only solution is to enforce good metadata management practices from the beginning.
Account For Unstructured Data
In developed markets, medical device manufacturers can access reliable patient demographic data. However, when releasing a device into an unknown market or an emerging one, the company may lack such access. Or such data may not even be present.
In such environments, pre-market testing will be limited and companies will rely on PMS data to improve and iterate on their devices. While this approach makes business sense, it throws significant data challenges. For starters, the company won’t know what kind of data it will receive.
It might receive data in formats or structures it cannot process. To account for such situations, companies must invest in resources that help them store unstructured data. Rigid storage infrastructure will limit the company’s ability to analyze data and improve its devices.
While building flexibility is important, companies must also preserve the context behind each dataset gathered. This practice prevents any misunderstanding or misclassification of data down the road. Again, an unstructured data storage solution helps companies execute this process.
Post-Market Surveillance Is Critical
Medical devices cannot succeed without good PMS and the way companies handle data is critical. The tips stated in this article will help companies secure and use their data in useful ways, guaranteeing device success.
