Collaboration is the secret sauce for success in risk management
Insights from a Let's Talk Risk! conversation with Hugo Felix
Note: this article highlights key insights gained from a conversation with Hugo Felix as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.
Summary
Here are a few key points that emerged from our discussion:
To manage risk effectively, we need a culture of collaboration
Collaboration requires effort to build a common understanding and shared language
Leaders must consistently model the right behaviors to shape culture
Let us dive in.
To manage risk effectively, we need a culture of collaboration
Risk management is a team sport. It takes expertise from different functions to fully understand the nature of risk and identify appropriate risk control options. It is not just engineering or manufacturing or quality or clinical; it is all functions working together. As devices become more complex, it is even more important for cross-functional teams to look at risk from different lenses. This is how we get to the most optimal solution that effectively addresses all of product requirements, including safety.
We need to create an environment where different views are expressed and considered in an open way. A collaborative environment also promotes clear communication, structure and consistency in the practice of risk management. But it does require work and top management support. It also requires continual monitoring through changes in the internal and external environment to maintain this culture.
Collaboration requires effort to build a common understanding and shared language
Collaboration does not happen on its own, it requires effort. A key feature of collaborative teams is that they have a common understanding of the mission and a shared language, especially when it comes to risk management. Terminology used in risk management can be confusing. The term risk itself can be interpreted differently by different team members based on their unique personal experiences and values. Anther example is the term stability - it is understood differently by device experts and pharma experts. This may become a challenge when a cross-functional team is working on a combination product.
Evaluation of benefit-risk is an exercise which involves a considerable amount of judgment. Without a common understanding and a shared language of risk, it is not uncommon to see confusion, conflict and errors in judgment when evaluating benefit-risk. In these situations, we cannot simply stop at the surface-level understanding and assume alignment; we have to go deeper by walking through different examples to establish a common understanding. It takes practice and concerted effort.
A culture of collaboration is tested in a time of crisis
When we are confronted with a difficult situation, such as a warning letter or a recall - and it does happen frequently in the medical device industry - a culture of collaboration is the difference between success and failure. In a culture of collaboration, there is no finger pointing; rather everyone works together to find a solution to overcome the crisis.
In a culture of open communication that flows effortlessly throughout the organization, you have a much better chance of success. It is fashionable to talk about an open, collaborative culture, or a boundaryless organization. But the test of your culture is during the moment of crisis. It is during a real crisis that you can learn about the strengths and weaknesses of your system, and consider improvements that will prepare you for another crisis in the future.
Leaders must consistently model the right behaviors to shape culture
As a leader, you set the expectations and tone for desired behaviors. Then you must live them consistently to set a clear, visible example for your team to follow. When leaders across the organization practice the same values and behaviors, they create a critical mass for the entire culture to change. It is not through a top-down edict that an organization builds and sustains a culture of collaboration. It is through leaders throughout the organization modeling the desired behaviors that culture happens.
No other time the appropriate leader behavior is more critical than during a time of crisis, or when mistakes are made. How do we react? Do we point fingers and assign blame at another department? Do we search for a scapegoat to assign blame and take the fall? Or do we take ownership and treat the situation as a common challenge? As a leader, we have to be mindful of our own behavior, especially during a time of crisis.
Tools are useful but process is more important. Tools must facilitate a solutions that fits the culture
Medical industry is going through a huge transformation, especially in light of developments in the artificial intelligence/machine learning (AI/ML) space. There are many new tools available now that we didn’t have before. There are new standards, guidance and other emerging best practices.
We have to be aware of these new developments. But we must not get so enamored with the next new tool that we forget about how they help us find solutions to our problems in the context of our own culture. It is useful to build an internal competence to help us translate these tools for application in our processes. Process effectiveness matters more than a quick deployment of a fancy tool.
We should approach the new standards and other best practices in a similar way. Standards are our friend, but only when we apply them in a way that fits our processes. When we must change our processes, we should take a careful look at not only the immediate change(s), but also its impact on the culture. Leveraging a culture of collaboration, we can find the most effective way to implement new standards and tools.
About Hugo Felix
Hugo Felix has 25 plus years of industry experience in devices, in-vitro diagnostics, pharmaceuticals and combination products, where he has helped build compliant patient-centric solutions by impacting quality cultures through strategy, cross-functional collaboration and organizational design. He has served in leadership roles in both early start-ups and large organizations. Currently, he is a Director of medical device and combination products quality assurance at Pfizer.
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 article are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.