Enhancing traditional risk management

Recently Harvard Business Review published an interesting article “A better approach to avoiding misconduct” in the May-June 2022 issue where behavioral risk management in #FinTech area is discussed. I believe this approach can be extended to #MedTech field as well. This is particularly important in the light of the #MDD #MDR transition and noise around.?

In a nutshell, the traditional methods of risk management can be honed with analyzing processes and organizational structures to identify the elements that trigger risky behavior. According to the article, “a large body of behavioral research shows that people’s desire to achieve a quantitative goal can cause them to ignore compliance or integrity standards expressed as qualitative goals.”?

How to tackle this??

Two ways are proposed:

1. Nudge lab. It is a brainstorming where stakeholders are getting around the table and identifying simple nudge that would change their handling of specific behavior.?For instance, different functions are engaged into medical device development as the processes are intertwined and depend on each other. Unfortunately, there is a quite common challenge as insufficient collaboration and communication across units. Nudge lab practice could help employees who are working in specific areas or processes to develop nudges that simulated the desired behaviors.?
2. System-in-the-room session. It’s a workshop for senior management with the purpose of creating a shared and complete understanding of the challenges involved in managing identified behavioral risks. This method could help to design preventive measures and optimize the process so as to reduce the probability of occurrence of risky behavior.?

To sum up, we could use baby steps to implement available best practices to increase compliance maturity of the organization and as a result product quality.?