Our Cybersecurity Strategic Committee is made up of the following FDA and industry experts:
Product Design Owner
Pat Baird is a Product Design Owner at Baxter Healthcare, with oversight responsibility to $400M+ in fielded product. His previous roles included software developer, function manager, program manager, and engineering department manager. He has published and presented on topics ranging from software development to change management to stakeholder management to risk management.
He is currently the co-chair of the AAMI Infusion Pump Standards committee, chair of the Assurance Case Technical Information Report Working Group, a US representative to the IEC standards committee, and is one of the founders of the Infusion Systems Safety Council. He is pursuing a master's in healthcare quality and patient safety at Northwestern University.
Consultant – Global Device Quality Assurance
In his current role, Bob authors global medical device quality standards and common quality practice documents. He also provides oversight to changes to the Lilly device QMS in order to support Lilly digital device initiatives (including Mobile Medical Applications). Bob also provides global device quality support with respect to medical device QMS auditing, risk management governance including medical device cybersecurity risk governance, product lifecycle management (PLM), and device regulatory surveillance. He has twice presented at past FDA/Xavier University Global Medical Device Conferences on MMA QMS and risk management.
He is a member of the AAMI Device Security Working Group responsible for drafting TIR97/Ed.1 Principles for medical device security – Post-market security management for device manufacturers. He has worked for Lilly for the past 15 years with prior extensive experience as a technical communication specialist in software, aerospace and manufacturing. He holds a bachelor of arts in journalism from Indiana University—Bloomington.
Sr. Director, Regulatory Affairs, CMC – Combination Products and Medical Devices
Mr. Chapman had 25 years of product and software development experience as developer and manager in the medical device and other industries before joining FDA in 2005. He was Chief of General Hospital Devices Branch for his last 5.5 years there. He specialized in software-based medical devices, medical devices with embedded software, infusion pumps, combination products, and new methods for regulatory review of premarket submissions. He has a masters degree in software engineering from the University of Minnesota. Mr. Chapman joined Biogen in 2016 as Senior Director for Regulatory Affairs CMC for Medical Devices and Combination Products.
Associate Director of Program Development
Michelle Rich joined Xavier University as the Associate Director of Program Development in January of 2017. Michelle spent nearly nine years as a National Account Manager at American Thermal Instruments, providing temperature monitoring solutions to pharmaceutical and medical device manufacturers to support supply chain compliance. Michelle also has a background in pharmaceutical sales. Michelle holds a B.S. in organizational communication from Ohio University.
Co-Founder and President
Fubin Wu is the co-founder and president of GessNet, providing risk management and cybersecurity consulting and software solutions. Prior to GessNet, Fubin had spent over 16 years on medical device quality and regulatory affairs, hardware/software reliability engineering and risk management, serving roles from engineers to managers and directors. He has experience in drug delivery combination products, mobile medical applications, implantable devices and remote monitoring systems, infusion pumps, and blood management standalone software devices. Fubin has an M.S. degree in electrical and computer engineering from Oregon Health & Science University (OHSU), and was a software developer at Intel prior to his career in the medical device industry.