The term risk is generally understood as something to be avoided or minimized. In the medical device and pharma industries, risk is generally associated with harm to patients. Regulatory agencies expect the benefits of a medical product to outweigh the risks associated with its use before it can be considered as safe and effective. As a result, the dominant view of risk in the medical device world is that risk needs to be controlled and minimized for patient safety and regulatory compliance. ISO 14971.
But risk also means opportunity. “No risk, no reward”, is a often invoked as a mantra to encourage achievement, especially in business. Sometimes the highest risk maybe the one you did not take when it was worth taking! Risk, therefore, can be perceived both as a negative force to be avoided, or as a positive force to be leveraged.
In this episode, Jayet Moon and Arun Mathew remind us to keep the big picture in mind for risk management. Safety is an important business objective, but not the only one. We need to help our organizations manage all types of risks to achieve business success.
About Jayet Moon
Jayet Moon is the author of Foundations of Quality Risk Management, published by the American Society for Quality (ASQ). He is a chartered quality professional in the UK and holds several certifications from the ASQ. In his current role as a Quality Manager at Terumo Medical Corporation, he is helping to integrate best practices in safe design and development of medical devices through is vast experience in engineering and post-market safety surveillance.
About Arun Mathew
Arun Mathew is currently an associate director of quality systems and risk management at AbbVie. He has over 17 years of diverse industry experience in roles ranging across quality, manufacturing and regulatory functions. His expertise includes medical standards, risk management, computer system validation, process validation, CE marking and FDA submissions.
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 10: Safety is important, but not the only objective for risk management