GettyImages-464576790 (1)-1

Executive Insights

Predicting Medical Device Safety Recalls Using Publicly Available Data


Analyzing Medical Device Recalls

Data concerning medical device safety events and recalls is readily available, especially in the US market, accounting for about 39% of the global market share. With the medical device market expected to grow at a CAGR of *6.1% starting in 2021, understanding the trends in safety and quality is more important than ever.

Analyzing root causes by downloading a large dataset from a public source may result in hours lost and frustration in finding any quick, useable knowledge. How do you turn disparate information into meaningful insights to manage risk and post-market surveillance activity? Can future prediction signals be obtained by looking deeply into past data trends and outcomes?

With the available history of adverse event reports, product design and performance defects captured and, in many cases, reported patient problems, we posed a hypothetical question: Can these data points be modeled to help understand if recall events are predictable in nature?

Taking the Power of Recalls Data Farther

To answer this and other questions, the Reed Tech team is leveraging data from the FDA and several other public sources to train a machine-learning algorithm to ‘predict’ recalls, and we are seeing startling results.

Using our insights, we believe many stakeholders can make better decisions that improve patient safety, mitigate reputational risks, improve product quality, make better financial decisions and guide policy decisions. The historical data has been normalized, aggregated and forms the core analytical database of Reed Tech Navigator™ for Medical Devices. The multi-iterative, criteria-driven model has shown directionally to predict medical device recalls. To date, testing of real-world performance has identified a small minority of products that account for most of the recalls. Specialty categories have yielded the most interesting results.

Download the white paper to see how Reed Tech is using the expansive data properties and analytics within Navigator to reliably test and predict medical device recall probabilities.

Navigator™ for Medical Devices is a unique best-in-class solution designed to help:

Identify safety trends Visualize trends with connected data, all in one place
Trust cleaned data management Understand reported product problems, adverse event reports, recalls and the root causes
Conduct quality comparisons Compare an individual device or a group of devices to gauge safety and quality profiles
See industry benchmarks Understand your product and a competitor's against industry benchmarks
Stay in the know with proactive safety alerts Get alerts when a new safety event or 510(k) occurs by setting a watchlist
Manage risk-Predictive Recalls Custom Analysis Request a Custom Analysis for a specialty category or a specific group of products-How likely is a recall?


For hands-on, filterable product search and a unified view of products, Reed Tech Navigator™ for Medical Devices places analysis at your fingertips.

Contact us to request a Predictive Recalls Custom Analysis, see a demo or just ask questions:


*source The Business Research Company October 2020

Download the White Paper