WIB-Seattle & ORCA: Digital Transformation in Healthcare & Regulatory Innovation

On August 27, WIB-Seattle and ORCA co-hosted an engaging panel and networking event at the Vue Research Center in Seattle, bringing together leaders from industry, academia, and tech governance to explore how digital transformation and regulatory innovation are shaping the future of healthcare. The expert panel—featuring Christine Zomorodian (empowerreg.ai), Michael Willingham (ex-Google Health & UW), Michael Petrini (GE HealthCare), Yingbo Shi (Dopl Technologies), Summer Radler (Lumen Bioscience), and Ty Kayam (FDA), and moderated by Beth O’Connor (Lyell Immunopharma)—shared forward-looking perspectives on the role of AI in diagnostics, manufacturing, and patient outcomes. Discussion highlighted the potential of digital twins and AI sandboxes to enable safe experimentation and accelerate product development, alongside the importance of real-world evidence and global harmonization in regulatory science. Key takeaways from the evening included the value of developing regulatory plans early, leveraging Digital Centers of Excellence for guidance, addressing workflow adoption challenges, and ensuring that speed and innovation are balanced with patient safety, user adoption, and regulatory readiness.

Panelists emphasized that advancing AI-driven healthcare requires balancing speed, safety, and regulatory readiness with strong ecosystem collaboration. Michael Petrini highlighted the need to build strong customer relationships by addressing pain points and data inconsistencies, while Ty Kayam noted the importance of ensuring the right resources reach the right people through risk-based approaches and improved user experience. Yingbo Shi stressed designing scalable systems without losing traceability and encouraged asking bold questions, such as how to mitigate the riskiest assumptions, while Michael Willingham reinforced the role of AI in product development and the use of digital twins to accelerate innovation. Christine Zomorodian underscored the importance of defining what falls under regulation, and Summer Radler emphasized prioritizing patient safety, product efficacy, and understanding regional regulatory differences. A heartfelt thanks to our panelists, sponsors, attendees, and volunteers for making this an insightful evening of knowledge-sharing. Special thanks to Lyell Immunopharma for generously hosting us at their beautiful venue.

Submitted by Ramya Parameswaran Rungta