Top 5 Trends in Post Market Surveillance
At Smarteeva we interact with a large number of medical device industry insiders and we pay careful attention to where their processes and investments are going. Most medical device processes are mature but new technology is opening up possibilities to better facilitate process adherence, efficiency and, ultimately, product safety. Here are the top 5 trends we have noticed in the past year:
More data collection and reporting –
This is happening both in the US and in Europe. FDA has sunset some of the summary reporting requirements and following the experience with various implantable devices, FDA is requiring most adverse events to end up in the public MAUDE system. This means individual reports sent via the gateway or web trader. At the same time, the new MIR form released in the process of EUMDR goes from 4 pages to 12 and requires a lot more information to be mapped/collected and reported.
Risk Analysis –
Risk Analysis is very important and it is being required by the new EUMDR. This not only comes as a normal risk assessment during complaint processing but also as a mathematical number in the form of failure rates based on products sold/implanted/shipped/manufactured etc. We see more emphasis being put into the link between FMEAs/Pre-market failure analysis with Post Market failure rates and analysis.
Much closer collaboration between customer service and complaint handling/regulatory –
This has been happening for a long time for large device manufacturers and we are seeing that moved a lot more to mid-size and small manufacturers. Complaint processes routinely deal with customer service issues such as credit requests, product return and warranty/service contract related issues. We see a growing trend of the 2 groups having access to the same data and closely collaborating. Complaint Handling and regulatory are becoming a bigger part of an organization’s effort to squeeze operational efficiencies and increasing customer satisfaction
Customer self-service –
We see a growing trend of giving customers the ability to create complaints, check on their status and communicate with the regulatory department. There is an increased utilization of consumer technology in medical device companies and, again, desire to increase organizational efficiencies.
Automated field notification and recall management –
Recalls historically have been cumbersome, manual processes. There is a trend to invest in better technology to identify recalled products more quickly and connect them to customer shipment information or install base. Portal investments that customers have made to facilitate commercial processes are being expanded to include recall processes as well.