MedTech Innovation 360
Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach to product developments, which is why we'd like to share our wisdom with like-minded individuals, hence why we've created this podcast. Join us as we take a deep-dive into common product development topics and share our views.
MedTech Innovation 360
#8 Strategic Risk Management in MedTech Innovation
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.
