Dave Hadfield

Dave is a leader within Kalypso’s life sciences practice and builds high performing teams to leverage a wide variety of digital technologies to achieve these goals.

He brings a deep passion for the life sciences industry that stems from witnessing firsthand the incredible impact that medical technology can have to improve or save the lives of people, including his own family experiences.

Current Projects

Dave has knowledge across 40+ common areas of the product lifecycle from R&D to Supply Chain, Quality and Regulatory. He has a deep understanding of relevant (to the digital-thread) medical devices regulations, including 21-CFR-820, 21-CFR-11, ISO 13485, ISO 14971 to name a few.

Dave oversees projects that leverage many types of technologies across the digital thread and is functionally experienced in a variety of platforms, including PLM, IoT, AR/VR and Reporting and Analytics.

He has worked to help transform aspects of the digital product information backbone for a wide variety of life sciences including over half of the top 20 medical companies on the S&P 500.

Areas of Focus:

I am excited to help clients achieve breakthrough business outcomes with a variety of technologies throughout the digital thread that ties the various stages of the product lifecycle together, including:

• PLM: Lead the implementation of enterprise scale Product Lifecycle Management to provide a data backbone.
• “Big” Product Data: The processes to specify, curate and migrate data for products.

• Digital QMS: Provide closed loop feedback, by managing the quality issues and user feedback (Digital QMS)
• RIMS: Regulatory Information Management, for example, tracking and managing the approval of products.
• AR/VR: Visualize the digital twin of the product at different stages using AR/VR/XR experiences

Outside of Kalypso

Dave is from the UK, and lives in FL with his family and is interested in technology, artificial intelligence, game development, personal IoT, virtual reality and science fiction. He enjoys scuba diving, skiing, cycling, board games, electronic dance music and attempts at cooking a wide variety of international food (not always well).