The practice of risk management in a heavily regulated industry such as medical devices is hard. There are many challenging questions that must be resolved in a simple way that is both sensible and defensible to demonstrate compliance with regulatory requirements.
Questions such as how should we estimate P1 and P2 for each risk? How do analyze benefit vs. risk? How do we analyze risks associated with use of artificial intelligence and machine learning (AI/ML)? What should be our criteria for risk acceptability? How do we manage the many moving parts of our risk management file to ensure its integrity?
There are no clear cut answers to these practical challenges. That is why Bijan Elahi, a leading expert in safety risk management of medical devices, encourages us to collaborate more to find creative solutions to these thorny problems.
There is no shortage of tough problems in risk management. Talking to each other will open up ways and solutions that you may not have imagined.
Collaboration cannot be forced. It requires a willingness and a sense of generosity in sharing our unique insights openly with each other. Management can help by creating an environment where everyone feels safe to engage and share freely. But it is up to all of us to work together and collaborate. Risk management is truly a team sport!
In this highly inspirational conversation, Bijan shares his perspective and tips for improving collaboration in risk management.
About Bijan Elahi
Bijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. He currently serves as a technical fellow and corporate advisor on product safety risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. He has trained over 10,000 people worldwide and his book Safety Risk Management of Medical Devices, now in its second edition, is a bestseller.
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 35: Tips for improving collaboration in risk management