Tips for improving collaboration in risk managementJan 22, 2024
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.