The United States Food and Drug Administration (FDA) is a federal regulatory agency in the Department of Health and Human Services. The FDA protects and promotes public health through multiple centers, offices, and divisions. These entities control and supervise food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods and feed, and veterinary products.
The Center for Devices and Radiological Health (CDRH) is one of the Centers within the FDA. They ensure patients and providers have access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, caregivers, and medical providers with science-based information about products. They also facilitate medical device innovation by advancing regulatory science, providing the industry with predictable, consistent, transparent, and efficient regulatory pathways, and ensuring consumer confidence in devices marketed in the U.S.
THE CHALLENGE
With 18,000 employees, the FDA is in an ongoing state of data modernization. CDRH, comprised of 2,000 staff, has been working to move multiple on-prem data sources into a cloud environment. The challenge became that their primary analytic tool was not able to access the new data source. Similarly, they wanted to ensure that staff had the same, and in many cases more robust, access to the data that they had in the past, allowing for democratization of their data assets. Another sticking point was perceived ease of use and the semantic layer of the current reporting infrastructure.
That said, in some cases, staff were exporting data from their legacy BI tool and conducting their work in Excel, which is not an efficient way for anyone to work and is ripe for quality issues. The goal of CDRH was to acquire a solution which had all those capabilities within one platform, so the end users could have all that functionality in one interface without having to go outside the system.
When it was announced that a new release of their legacy business intelligence tool would require significant reprogramming to their reports, as well as a reinvestment, they decided that the time was right for a change. The CDRH team referred to the Gartner Magic Quadrant for ABI Platforms for a better solution. They even met with Gartner subject matter experts for recommendations on finding their best analytics partner, and a Gartner analyst suggested they evaluate Pyramid Analytics.
CDRH’s evaluation process consisted of a team of individuals who were part and parcel to the evaluation as voting members, as well as multiple stakeholders attending the demonstrations and discussions to ensure that everyone’s perspective was included. Lastly, those additional stakeholders reported to their respective voting member with what their choice was. All said and done, Pyramid came out ahead of the pack.
CDRH stakeholders liked Pyramid’s flexibility for people of all levels of technical ability, from no-code/low-code users to machine learning coders in Python and R. They found the user interface to be relatively intuitive. The CDRH team liked that you could analyze and create reports using direct query, as well as the variety of visualizations.
They were impressed with Pyramid’s ability to connect to a large amount of data sources and targets, as it was more robust and streamlined than their other data analytic platform. They liked having everything centralized in one platform. Lastly, they also liked the semantic layer and how they could really keep track of what is going into the data models that users are creating, as well as what changes are being made.
