Fubin Wu
GessNet
Co-founder & President
Fubin Wu is the Co-founder & President of GessNet, a company at the forefront of advancing medical product development and lifecycle management through best-practice software solutions and expert consulting. He is the architect behind QMSpace, a unified digital platform for managing medical products using a model-based systems engineering (MBSE) approach—integrating requirements management, design controls, risk management, Quality by Design (QbD), cybersecurity, and safety assurance cases.
With over 30 years of experience, Fubin has partnered with more than 40 organizations—from startups to global industry leaders—to bring innovative medical technologies to market. His expertise spans drug-device combination products, infusion pumps, Smart and Autonomous Medical Systems (SaAMS), implantable devices, patient monitoring technologies, robotic surgery platforms, and Software as a Medical Device (SaMD).
Fubin is recognized for championing a holistic systems engineering approach, emphasizing end-to-end digitalization and visualization to enable scalable, reusable, and lifecycle-resilient medical product systems. His work focuses on connecting top-level safety and performance goals (claims) to detailed engineering artifacts, mapping complex interdependencies, and enabling proactive decision-making across the product lifecycle. He has led the development of over 30 safety assurance cases—successfully demonstrating safety and effectiveness to the FDA across complex drug delivery systems.
Prior to founding GessNet in 2011, Fubin held leadership roles at Medtronic and Hospira, where he served as Director and Manager of Quality. He began his career as a software engineer at Intel.
He holds a master’s degree in Electrical and Computer Engineering from Oregon Health & Science University.
With over 30 years of experience, Fubin has partnered with more than 40 organizations—from startups to global industry leaders—to bring innovative medical technologies to market. His expertise spans drug-device combination products, infusion pumps, Smart and Autonomous Medical Systems (SaAMS), implantable devices, patient monitoring technologies, robotic surgery platforms, and Software as a Medical Device (SaMD).
Fubin is recognized for championing a holistic systems engineering approach, emphasizing end-to-end digitalization and visualization to enable scalable, reusable, and lifecycle-resilient medical product systems. His work focuses on connecting top-level safety and performance goals (claims) to detailed engineering artifacts, mapping complex interdependencies, and enabling proactive decision-making across the product lifecycle. He has led the development of over 30 safety assurance cases—successfully demonstrating safety and effectiveness to the FDA across complex drug delivery systems.
Prior to founding GessNet in 2011, Fubin held leadership roles at Medtronic and Hospira, where he served as Director and Manager of Quality. He began his career as a software engineer at Intel.
He holds a master’s degree in Electrical and Computer Engineering from Oregon Health & Science University.