In this episode of the MedTech Innovation 360, we delve into risk assessment and management within medical device development. Exploring the definitions of risk, we differentiate between risk assessment and risk management, stressing the importance of early identification and mitigation. Key points include the relationship between risk and hazards, the role of Failure Modes Effects Analysis (FMEA) in identifying potential failures, the significance of ISO 14971 as a guiding standard, and the integration of user and design perspectives in comprehensive risk analysis. Practical examples, such as sidewalk cracks, illustrate risk analysis criteria. We also emphasize considering manufacturing processes and material properties for product safety and functionality. Throughout, we employ real-world analogies and detailed examples to make complex concepts accessible, aiming to help medical device professionals enhance product safety and efficacy through meticulous risk analysis and proactive design adjustments.