MDIAS Studies

MDIAS Initial Studies

The MDIAS team conducted two studies during the Proof of Concept (POC) phase 1 using FDA public data sources in 2021. The purpose of the POC is to explore how the MDIAS partnership model could operate and whether it could advance device quality and patient safety. The two studies conducted, laid the groundwork for establishing trust among participating organizations and showed MDIAS’ ability to enable collaborative decision-making. The final outputs provided valuable insights and a new view into these areas.

StudiesGoal of StudiesOutput of Studies
1. How are Primary Root Causes of Recalls Distributed?The goal of this study was to take a deeper dive into recalls and understand the distribution of root causes of recalls. MDIAS used data visualizations to explore, categorize, and describe trends in root causes of recalls from 2010 to 2019.- Visualizations that display the distribution of recalls in terms of seven dimensions (medical specialty, recall class, etc.).

- Benchmarks that allow individual early adopters to view the recall distribution for their devices compared to the industry as a whole.
2. Are Medical Device Reports (MDRs) Predictive of Recalls?The goal of this study was to build a capability that identified groups of medical devices that may need special attention based on their adverse event history. MDIAS applied data science to 1) identify factors most associated with future recalls and 2) predict devices with a high probability for recall.- Model that can predict 75% of recalls and 58% of non-recalls for devices with recent MDRs.

Example Visualization for Study 1 (Not Reflective of Actual Data)

Studies Example 1 Visualization

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