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Case Study

FDA Center for Devices and Radiological Health transforms with Pega

  • Improved user experience for internal customers and external stakeholders
  • 18,000 submissions handled annually
  • Supporting 2,000 FDA medical device approvers nationwide

“I had the opportunity to speak to industry last week. And the feedback on the customer collaboration portal – the ability to see their status and to submit electronically – has been a tremendous success! One person said: ‘I’ve been working with the FDA for 37 years and its about time!”

The Business Issue

The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates an extensive array of products ranging from everyday medical devices like Apple watches to essential medical equipment, such as wheelchairs and personal protective equipment. With over 23,000 different products under its purview and an annual workload of 18,000 submissions for medical device approvals, the CDRH is the second largest center at the FDA.

Yet fragmented systems and challenges posed by data management and governance made it hard for the center to meet its public health mission effectively. CDRH had long relied on legacy systems with limited ability to make improvements due to high costs and long lead times. Its submission processes were dependent on the manual creation of submission packages that are then sent to CDRH via U.S. mail. This led to challenges in finding and linking information in siloed systems, as submission packages consist primarily of unstructured data.

The CDRH recognized the need for a comprehensive transformation to revolutionize its review processes and information sharing, particularly focusing on data management and governance and enabling data-driven decision-making.

The Solution

FDA CDRH implemented the Pega Platform™ and began its digital transformation journey. Using the platform, CDRH built a decision management portal and customer collaboration portal, both hosted on Pega Government Cloud. Both were significant milestones in CDRH's journey.

The decision management portal acts as a one-stop-shop for internal staff, providing a centralized platform for their tasks and administrative activities. Through integration with external systems and the use of Pega UI, CDRH created a consistent user experience across internal and external stakeholders. CDRH also developed a progress tracker to provide situational awareness on submissions to external users.

The customer collaboration portal revolutionized the submission process, allowing for electronic submissions and providing real-time updates on the progress of submissions. CDRH prioritized user experience and aimed to enhance collaboration with external stakeholders, leveraging Pega features such as knowledge management, co-browsing, and mailbox automation.

The Results

  • 18,000 submissions handled annually
  • Supporting 2,000 FDA medical device approvers nationwide
  • Streamlined nine systems into one with simpler logins for approvers

With its new customer collaboration portal, external stakeholders can track the status of their submissions and submit documents electronically. This transformation eliminated the need for manual processes and the reliance on traditional mail delivery. The success of the customer collaboration portal has inspired CDRH to extend these benefits to internal staff as well. Its next goal is reducing the burden on staff members and enhancing the efficiency of the medical device review process.

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Industry: Government Product Area: Platform Solution Area: Enterprise Modernization
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