Fubin Wu GessNet™

Fubin Wu is the Co-Founder and President of GessNet™, providing consulting and software tools for medical device and drug device combination product risk management, safety assurance cases, cybersecurity, and reliability.

Having served for over 30 companies, Fubin has experience with a broad range of medical products including drug delivery combination products, infusion pumps, insulin pumps, on-body injectors, emergency use injectors, mobile medical applications, digital solutions, implantable devices, cardiovascular devices, robotic surgery devices, IVDs, remote monitoring systems, and blood management systems. He is a member of multiple AAMI working groups including infusion devices, combination products, cybersecurity, and software. He also teaches public courses on medical device and combination product risk management, safety assurance cases, cybersecurity, and software reliability.

Prior to GessNet™, Fubin worked for Medtronic, Hospira, and Haemonetics in the roles of engineer, manager, and director, and spent over 16 years on hardware/software quality and reliability engineering, risk management, and quality management systems.

Fubin has an MS degree in Electrical and Computer Engineering from Oregon Health & Science University (OHSU) and was a software developer at Intel before joining the medical device industry.