Xavier Health is excited to include key thought leaders in the medical device and combination products cybersecurity space. Participants will have the opportunity to draw from the Cybersecurity Summit discussion leaders' vast experience through meaningful conversation and collaboration throughout the conference.
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.
Cybersecurity Program Manager
Dr. Carmody is the Cybersecurity Program Manager for the Center for Devices and Radiological Health, serving as co-chair of CDRH’s Cybersecurity Working Group. The Cybersecurity Working Group is an interdisciplinary team responsible for the FDA’s final pre- and post- market cybersecurity guidances as well as incident response. Seth joined CDRH in 2011 as a medical device reviewer.
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.
Principal Regulatory Affairs Specialist
Michelle Jump is a Principal Regulatory Affairs Specialist at Stryker Corporation, with over 15 years of experience in the regulated health industry. She serves as an internal technical expert, advising development teams and management on technical standards and regulatory strategy for software, security, mobile apps, emerging technology, and connected devices.
She a project lead for several domestic and international standards in connected health and cybersecurity. Ms. Jump is the co-chair of the AdvaMed Software Working group and AAMI Health Software Quality working group, member of the AAMI Standards Board, and a U.S. delegate of ISO TC 215 and IEC TC 62/ SC 62A.
Ms. Jump holds a master of science in regulatory science from the University of Southern California and a Master of Science in Biotechnology from California State University. She is also RAC certified and a HIPAA-Certified Administrator.
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.
Federal Trade Commission
Jon Miller Steiger is the Director of the East Central Region of the Federal Trade Commission, based in Cleveland, Ohio. The East Central Region covers consumer protection and education issues for Delaware, Washington DC, Maryland, Michigan, Ohio, Pennsylvania, Virginia, and West Virginia.
He received his law degree from Columbia Law School, and then clerked for Judge Avern Cohn in the U.S. District Court for the Eastern District of Michigan. Jon started his legal career at the Federal Trade Commission’s headquarters, in Washington, DC. He returned home to Cleveland in 2001, with his wife and two children, staying with the FTC as a litigator before becoming Assistant Regional Director in 2005, and Director in 2009.
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.