Pegasystems Inc. · NASDAQ:PEGA
Pegasystems — PegaWorld Inspire 2023
18 slides from Pegasystems's conference presentation, 2023
Slide 1: CDRH Promotes Digital Transformation
CDRH Promotes Digital Transformation Elizabeth McNamara Program Director, Digital Transformation FDA, Center for Devices and Radiological Health (CDRH) Kenneth Sullivan Principal Booz Allen Hamilton © 2023 Pegasystems Inc.
Slide 2: CDRH Promotes Digital Transformation
CDRH Promotes Digital Transformation 2
Slide 3: Disclaimer
Disclaimer: The view and opinions presented here represent those of the speaker and should not be considered to represent advice or guidance on behalf of the U.S. Food and Drug Administration 3
Slide 4: CDRH Mission Statement
“CDRH Mission Statement” • The Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting public health by ensuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices. • To get ahead of stakeholder dema
Slide 5: Digital Transformation Goals
Digital “Evolve how we work today Transformation Goals to stay ahead of • Improve user experience for both tomorrow’s challenges” customers inside FDA and with external stakeholders DT Vision • Improve ability to make system enhancements quickly • Improve ability to accept and analyze data Digital •
Slide 6: Previous State of Affairs
Previous State of Affairs Reliance on legacy systems: • Siloed capabilities • Limited ability to make improvements due to high cost and long time to complete • Compatibility issues with current systems and new applications • Challenges in finding and linking information in our systems 6
Slide 7: CDRH/Pega Partnership
CDRH /Pega Partnership Today, we’re going to focus on three key elements of the digital transformation journey 1. Establishing the foundation 2. Business process/workflows 3. Customer collaboration 7
Slide 8: Establishing The Foundation
Establishing The Foundation 8
Slide 9: Business Process Development and Technology Support
Business Process Technology Support Development General technology • Establish a product driven mindset • Utilize cloud architecture based on Agile principles to foster high quality, consistent delivery of • Modernize technology stack capabilities, features and products • Optimize use of enterprise
Slide 10: Foundational Road Map
Foundational Road Map You are here • CDRH portal (external) Data • Enterprise reference architecture product • Decision mgt portal • Modernized tech stack integration (internal) • Pega layer cake • Additional • Medical device review (MDR) workflows (TPLC) • UI design system v1.0 • 510(k) and pre-sub
Slide 11: Decision Management Portal
Decision Management Portal Provide centralize, uniform access to all CDRH Staff 11
Slide 12: Customer Collaboration Portal
Customer Collaboration Portal Challenge: CDRH developed the CDRH portal – • External stakeholders demand – View progress tracker information about the status of their – Submit electronically In Production device submission – Manage access • Submission processes are dependent – Collaboration upon man
Slide 13: Customer Collaboration Journey Map
Customer Collaboration Journey Map You are here Basic portal Electronic • Security submissions • Access control • Estar Structured • Login • Ecopy ingest Progress tracker Progress tracker Customer relationship • 510(k) • Pre-submission mgt (CRM) • Traditional User access mgt • Collaboration • Specia
Slide 14: Progress Tracker
Progress Tracker View the status of your submission • Data pulled from external (legacy) system • Plain language explanation • Business rules drive display of timeline and detailed information • Consistent user experience • Ability to provide customer feedback 14
Slide 15: Electronic Submissions
Electronic Submissions Simple file upload with background format checks and vulnerability scans • Simple cloud integration with FDA GovCloud backend services • Easy to use drag and drop interface • Confirmation email • Easy to share status with colleagues 15
Slide 16: Customer Collaboration Portal
Customer Collaboration Portal Configure Pega CRM Potential features • Knowledge management • Next best action advisor • Co-browse • Unified reviewer/submitter desktop • Web messaging • Mailbox automation 16
Slide 17: Quotes from Industry Users
Quotes from Industry Users I love the portal. Such a I am writing to express delight to use after 34yrs how absolutely impressed of fedexing in I am with this portal. It is submissions easy and convenient Good morning. I will start my email by saying fda's CCP is terrific! Thank you for all of the w
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