Fubin Wu MS GessNet

Fubin Wu is the co-founder and president of GessNet, a company dedicated to providing best practice-based software solutions and expert consulting to develop and maintain safe, effective, and compliant medical products. Fubin has worked with over 35 clients, from startups to top leaders in the pharmaceutical and medical device industries, and has experience with a wide range of medical products, including: Drug-device combination products (prefilled syringes and auto injectors, on-body drug delivery systems), Infusion pumps, Software as a Medical Device (SaMD), Robotic surgery devices, Implantable devices, Patient monitoring systems. He is a member of multiple AAMI working groups and a public instructor on risk management, cybersecurity, and safety assurance cases. He has guided the development of over 25 safety assurance cases, which holistically explain to the FDA why medical products are safe and effective. Prior to founding GessNet, Fubin had over 16 years of experience working at medical device companies such as Medtronic and Hospira. Fubin holds an MS degree in Electrical and Computer Engineering from Oregon Health & Science University. He was a software developer at Intel before entering the medical device industry.