One of the key requirements of ISO 13485, the International Standard for medical device Quality Management Systems is establish a link between risk management and the design and development process.
In practice this proves to be quite challenging.
In this Let’s Talk Risk! conversation, Chuck Ventura shares that medical device design and development process is a chaotic process. Design controls should be considered as a way to keep track and stay organized in the face of inherent chaos of the process. In the context of Design Controls, it is helpful to see risk analysis as an aspect of good engineering and not just a paper exercise.
When risk analysis is integrated early in the design process, it helps inform design choices to optimize both safety and performance of the medical device. As an example, when you are trying to decide among various design choices represented by different prototypes, it may be helpful to conduct early usability studies to find out potential use-related issues and failures. Design choices that eliminate potential use-errors are more effective in reducing risk and delivering a final product that is both safe and effective.
A best practice is to start with a systems-level risk analysis to develop a preliminary understanding of hazards and hazardous situations. As our understanding of risks evolves, more sophisticated techniques such as design FMEAs can be applied to different design concepts to fully analyze failure risks in the context of identified hazards and hazardous situations.
Listen to this Let’s Talk Risk! conversation with Chuck Ventura which also includes an open discussion with the audience.
About Chuck Ventura
Chuck Ventura is currently the Founder and CEO at Ventura Solutions, LLC, a consulting firm specializing in end-to-end consulting, staffing and training services for the medical device and combination products industry. He has nearly 20 years of experience in the Life Sciences industry across a variety of roles in product development, risk management, design controls, project management audits and inspection readiness. He is a biomechanical engineer with advanced graduate degrees in aerospace and mechanical engineering.
About Let’s Talk Risk! with Dr. Naveen Agarwal
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR 43: Tips for integrating risk analysis with design controls