How Smarteeva’s MAUDE Analysis Reveals the Top MDR Submitters in 2022

How Smarteeva Built the Analysis

Raw MAUDE data is messy. Manufacturer names are inconsistent. Parent companies are not identified. Device registrations are in a separate database. Smarteeva’s MDREngine project cleaned the data, normalized company names, linked MDRs to device registrations, and created a unified parent company view across 2.6M+ records.

This is the kind of analysis that individual manufacturers cannot do efficiently on their own. It requires cross-referencing multiple FDA databases and resolving naming conflicts at scale.

What the 2022 Rankings Show

Becton Dickinson replaced Medtronic at the top of the MDR submission rankings in 2022. This was driven largely by the volume of Alaris infusion pump reports and the overall growth of BD’s device portfolio.

Several companies that would not have appeared on this list five years ago are now among the top MDR generators. This reflects the rise of newer device technologies, particularly in diabetes management, remote monitoring, and connected devices. Higher MDR volume correlates with rising sales and distribution, not necessarily with product quality issues.

This distinction matters. A company that sells 10 million units and files 50,000 MDRs has a very different risk profile than one that sells 100,000 units and files 5,000. Raw MDR counts without utilization context are misleading.

Why This Data Matters for Your Organization

Knowing where your company ranks against peers is operational intelligence. If your MDR volume is growing faster than your sales volume, that is a signal. If a competitor’s MDR profile is shifting, that is competitive intelligence. If a new entrant in your device category is suddenly generating high MDR volumes, that tells you something about market dynamics.

Smarteeva’s MDREngine provides all of this. Search by manufacturer, device type, event code, or time period across the full MAUDE dataset. Set alerts for changes in competitor filing patterns. Benchmark your device’s safety profile against the industry.

2.6M+ global safety records in MDREngine

Closing

The top MDR submitter rankings change every year, and the companies at the top are not always the ones you would expect. Smarteeva’s MDREngine gives quality and regulatory teams the tools to track these shifts, benchmark against peers, and detect signals in the data before they become problems.

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