In our last post, we discussed how the media, Congress and the FDA is paying increased attention in recent years to medical device safety. We highlighted the cost to the device industry of FDA enforcement actions (Reed Tech estimates $4 billion per year). We also emphasized the importance of manufacturers conducting regular postmarket surveillance reviews of their products.
In this post, we’ll take a closer look at the available data sources for these reviews and see what this data can tell us.
There is a staggering amount of U.S. market data available from government sources. MAUDE, MedSun and other FDA databases house adverse event reports, recall notices, warning letters, surveillance studies, safety alerts, inspection findings and agency announcements about injunctions, seizures and consent decrees. Clinical trial results are compiled by the National Institutes of Health (NIH) and published on ClinicalTrials.gov.
Regulators outside the U.S. are collecting data as well. Australia’s Therapeutic Goods Administration (TGA) is just one example of a regulatory body beyond our borders publishing adverse event report data. In the EU, the European Council has just unveiled its new Medical Device Regulations (EUMDR), an initiative that includes making a lot more device safety data available through the European Database on Medical Devices (EUDAMED).
So, for device manufacturers who want to understand the safety and quality profiles of their products and see how they compare to competitors’, a lack of data is not the problem.
A careful analysis of the data available can yield valuable, actionable insights. For instance, a thorough study of adverse event reports can tell you if there are specific injuries more commonly associated with your product compared to similar devices. Digging deeper into that issue might tell you that the percentage of adverse event reports for your device indicating the issue of “material separation” has been climbing steady for the past several years, while your leading competitor’s product percentage has remained steady. That would be an issue you would want to investigate thoroughly to determine the underlying cause.
If the situation were reversed, with your product’s percentages for “material separation” remaining steady while your competitor’s was going up, your sales team might be able to leverage that as an opportunity to take market share from your competitor.
But there are a lot of barriers to conducting this kind of analysis. The sheer volume of the data, its disparate locations and varying formats present significant challenges. We will look at some of those challenges, and the steps for dealing with them, in our next post. If you can’t wait, head over to MD+DI’s website and watch our recent webinar, Drowning in Big Data, on-demand. Or you can contact the Reed Tech Life Sciences team to discuss how to leverage the available data to extract actionable insights for your products.