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 ...
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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 ...
#4 The Art of Innovation: How Industrial Design Shapes Medical Devices
MedTech Innovation 360
48 minutes
2 years ago
#4 The Art of Innovation: How Industrial Design Shapes Medical Devices
In this episode, we explore the often overlooked role of industrial design in shaping medical devices. Medical devices are vital in healthcare, saving lives and enhancing patient care, yet industrial design's significance is often underestimated. We delve into the crucial role of industrial design, examining the unique challenges and opportunities it presents in medical device design. From cleanability and material properties to security, usability, risk mitigation, and human factors, we unco...
MedTech Innovation 360
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 ...
