Support for medical device complaints investigation

Industry regulations forces Medical Devices providers to handle device complaints within a 30 days time window. 

The Aim: 

Investigating Medical Device Complaints involves a manual effort. Getinge’s Quality, Regulations and Complaints department receives 300,000 - 400,000 complaints per year. They have a 30 day window of submitting a report to the FDA. However, investigators start every investigation from scratch leading to late submission penalties from the FDA.

Why Hopsworks? 

The goal was to enable investigators with decision support in bootstrapping the investigation labor leading to:

• Less time spent on investigations
• Less money spent on late penalties

Five types of medical devices are covered by the current model with 90 percent accuracy (on new complaints).

Results

Getinge has developed two models on Hopsworks: One that finds historically similar complaints based on sentence matching, and another that predicts the severity of the complaint. With the 'closed loop' training, models can be retrained/optimized with updated labels for “actuals ”.