Scaling Data In Regulated Industries: Architectures, Challenges & Opportunities

In this panel discussion during DataOps Day Boston, moderated by John Harrington, Chief Product Officer at HighByte, Richard Shaw from Smith & Nephew, Eric Marandett from Tulip, and Chris Demers from Skellig Automation explore how Industrial DataOps and modern automation tools are transforming regulated manufacturing.

The panel shares real-world insights on bridging IT, OT, and Quality to enable digital manufacturing in highly regulated environments. 

Topics include:

• How Smith & Nephew implemented electronic device history records using Tulip and HighByte Intelligence Hub to enhance data integrity and audit readiness.
• The FDA’s growing support for digital-first validation and data-driven audits.
• The value of open and interoperable architectures.
• How DataOps helps standardize and scale data to support predictive and AI-enabled operations.
• The evolving role of AI agents and DataOps in supporting knowledge workers and future-ready factories.