This is where collaboration becomes action. Pathway Collaborative Community members are invited to join centers tackling today's most complex industry challenges, from responsible AI adoption and human factors in medical devices to post-market surveillance and quality science research. Bring your expertise, join an initiative, and help build the solutions the industry needs. Real work. Real outcomes. Real impact for patients.
Pathway Collaborative Community Centers:
AI/Digital Center
The AI/Digital Center is a hub for the safe, effective, and responsible adoption of AI and digital technologies in regulated healthcare, carrying forward the work of the AI Healthcare Global Initiative (AI-GHI), founded at Xavier University in 2017 as one of the first FDA Collaborative Communities. The initiative continued under the AFDO/RAPS Healthcare Products Collaborative before transitioning to its current home in the Pathway Collaborative Community.
The Center unites regulators, industry, healthcare organizations, academia, standards bodies, and technology leaders to address challenges in AI, digital health, regulatory science, cybersecurity, and governance. Through consensus-based working groups, it develops practical frameworks, best practices, and implementation guidance to help organizations develop, validate, and deploy AI-enabled technologies while strengthening compliance and patient safety.
Check Out the Working Groups and Initiatives:
Human Factors Center
The Human Factors Center is Pathway for Patient Health’s hub for advancing the safe and effective design, evaluation, and use of medical devices through collaboration on human factors and usability. The Center unites regulators, industry, healthcare organizations, and researchers to address shared challenges at the intersection of human performance and device design.
Through consensus-based working groups, the Center focuses on use-related hazards in AI-enabled medical devices—evaluating whether current human factors methods adequately assess risk and developing practical recommendations on both the hazards to consider and the most effective methods for device assessment.
Center Leaders:
Check Out the Working Groups and Initiatives:
<<Human AI Systems Working Group>>
Post-Market Innovation Center
The Post-Market Innovation Center is Pathway for Patient Health’s hub for strengthening post-market surveillance and advancing the use of real-world evidence across regulated healthcare. The Center brings together regulators, industry, and healthcare organizations to evaluate and characterize the post-market data landscape and address emerging challenges in product performance monitoring and lifecycle management.
Through collaborative working groups, the Center develops practical frameworks and guidance to help organizations leverage post-market data—including under initiatives such as FDABAA-25-00123—to strengthen feedback loops, improve product quality, and support patient safety across the total product lifecycle.
Center Leader:
Check Out the Working Groups and Initiatives:
Quality Operations Center
The Quality Operations Center hosts working groups that explore the future of manufacturing, QMS, supply chain, and regulatory operations. The focus is on risk management, manufacturing modernization, QMS agility, and evolving regulatory expectations. Members collaborate across companies to anticipate industry change and apply practical insights back to their own organizations.
Check Out the Working Groups and Intiatives:
Quality Science Research Center (QSRC)
The Quality Science Research Center (QSRC) is Pathway for Patient Health’s applied research center dedicated to moving quality science from discussion into action. A program of Quality Champions for Life in partnership with Pathway for Patient Health, the QSRC bridges real-world challenges in healthcare, regulatory science, and patient-centered innovation with structured research and expert guidance.
The Center focuses on problems that matter beyond academia, producing credible evidence that supports better decisions, stronger quality practices, and more informed conversations across the life-science community. Through this model, the QSRC also gives students and alumni a meaningful pathway to grow as future quality professionals by engaging in real research with real-world impact.
Center Leaders:
