Medical Devices: Introduction to Risk Management

Pat Baird from Baxter International will provide a guest lecture on
the basics of medical device risk analysis — discussing tools and
techniques used to discover potential failures before they happen, and building in risk-controls to minimize the impact of failure.
Pat Baird is a Product Design Owner at Baxter Healthcare, with
oversight responsibility for $400M+ in field product. His previous
roles included software developer, functional manager, and program manager before moving to the Systems Engineering group. He has nearly 20 years experience in product development, and has published and presented over 30 papers 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, a member of the AdvaMed Infusion Pump and Clinical Trials Working Groups, and is one of the founders of the Infusion Systems Safety Council. He received the 2011 Standards Developer award from AAMI. He
has a BS in Computer Science, an MBA, and a MS in Healthcare Quality and Patient Safety from Northwestern University, in Chicago.