What does it take to make the call on a product recall when patient safety is at stake?

In this interactive workshop, industry leaders from medical devices, pharma, and life sciences will walk you through how engineering teams escalate and evaluate risks, even when information is incomplete. Working in small groups with our guests, you’ll step into real-world recall scenarios, grapple with the trade-offs, and practice making tough decisions under uncertainty. Together, we’ll debrief the approaches and insights that shape engineering leadership in critical moments.

Leaders

Karen Anigbo is a seasoned quality and product safety leader in the medical device and life sciences sector, with deep experience in complaints handling, field actions, and post-market risk management. At Johnson & Johnson, she served as Senior Manager for Complaints, Field Actions, and Post-Market, where she led cross-functional investigations into product issues, evaluated risk profiles, and helped guide decisions on corrective actions, including medical device product recalls. Her expertise in real-world response strategies that balance patient safety with technical risk is what she’ll bring to life for students in this workshop exploring how engineering leaders make tough, safety-critical calls.

Kim Soter is an accomplished quality leader, a former VP of Quality for Olympus Surgical and Quality & Compliance Director at Johnson & Johnson MedTech. With a career including leadership roles where she oversaw investigation and resolution of complex product issues, Kim has helped teams evaluate safety risks, engage cross-functional partners, and determine when field actions and recalls are necessary to protect patients and maintain regulatory compliance. Her practical experience navigating high-risk product quality challenges will give a front-row view into how engineering leaders make tough, risk-informed decisions that balance patient safety, technical integrity, and operational realities.