Medical Device Company Connects Diabetes-monitoring Hardware to Real Devices to Test User Conditions all Over the World

Client

This medical device company is the world’s largest standalone medical technology development company. They have a set of apps that connect to diabetes devices over bluetooth.

Challenge

  • FDA Requirements - In order to grow from 1 million to 20 million users by 2020, this medical device company is developing mobile applications that connect to insulin pumps and other medical devices that help patients and their doctors more accurately monitor treatment. Before they can release new apps, the app must pass all FDA requirements, a process that currently takes months. FDA requirements include testing on a specific device or OS prior to releasing into production. This translates into the requirement to test the device and OS the same day they are released.
  • Coverage Goals - To help acheive the 20 million user goal, the medical device company’s marketing team identified that they require an 80% market share. The more devices they tested on, the more they were compliant with FDA regulations, the more people they could offer the service to.
  • Regional Testing - The medical device company’s products are used all over the world and testing needed to reflect specific conditions unique to each region. After speaking with other teams, it was determined that manual testing in each region was not an option.

Solution

  • Real Devices All Over the World - Perfecto provided the medical device company instananeous access to thousands of real devices all over the globe with labs in the US, UK with plans to expand to China, Australia, and Japan.

Result

  • FDA Compliant – Now that the medical device company can test their hardware quickly and efficiently, the FDA approval process is shortened to weeks instead of months.
  • Test Coverage - The medical device company acheived 80% global coverage within the first two months with guidance from the Digital Test Coverage Index. This level of coverage has accelerate their time to market by 2 months.
  • Geo-based Testing - The medical device company is now able to run user condition testing customized to each region’s specifications. Acheiving this has strengthened the alignment between the product and marketing teams while complying with FDA requirements.