Fubin Wu MS GessNet

Fubin Wu is Co-founder & President of GessNet and creator of QMSpace, a unified digital platform advancing medical product development through assurance-centered model-based systems engineering (MBSE). With over 30 years of experience, he has supported 40+ organizations—from startups to global leaders—in developing technologies such as drug-device combination products, infusion pumps, SaMD, robotic surgery systems, and implantable devices. He is known for championing a safety-focused, holistic systems engineering approach that leverages end-to-end digitalization and visualization to build traceable, scalable, reusable, and lifecycle-resilient product systems. Fubin has led more than 30 FDA-facing safety assurance cases demonstrating safety and effectiveness across complex drug delivery systems. He previously held leadership roles at Medtronic and Hospira, began his career as a software developer at Intel, and holds a master’s degree in electrical and computer engineering from OHSU.