Insights from 5 recent Let's Talk Risk! conversations: May-June 2023
Catch up on recent conversations you may have missed.
Note: Each week, we talk to risk practitioners and thought leaders in a live LinkedIn audio event1. These are very casual and informal conversations about practical challenges and best practices for risk management of medical devices. Key highlights are published each week on Saturdays. Here are highlights from 5 recent Let’s Talk Risk! conversations you may have missed.
1. The most important question for risk management - who is taking the risk?
Risk practitioners tend to focus mainly on risk. There is a good reason for it because they are responsible for reducing risks to the extent possible in comparison to the anticipated benefits for the target population. A physician’s view on risk is in the context of an individual patient.
FDA has become quite active in gathering patient perspectives to inform high level policy decisions. Still, patients are not directly involved in regulatory decisions, which are generally based on safety and effectiveness data provided by manufacturers. Design and development of medical devices is engineering driven, and generally based on incremental innovations over existing predicates. Patients are not the direct customers of medical devices. Physician input is generally missing. As a result, there is a disconnect between patients, manufacturers and regulators.
Dr. Adam Saltman highlights the need to consider the patient perspective, either directly or indirectly through clinical experts during the design and development process. He emphasizes the question of “who is taking the risk?” in this Let’s Talk Risk! conversation. Listen to the full audio recording of our conversation embedded in this article.
2. Risk lessons learned from working on a hydrogen-powered car.
Hydrogen is a source of energy, but that does not mean a hydrogen-powered car is inherently dangerous or unsafe. Gasoline and diesel are also a highly flammable source of energy. However, common public perception is that using hydrogen as a fuel source in millions of cars may be higher risk. It is important to understand that just because a hazard source is present in a system does not mean it is inherently unsafe.
Andy David, shares some of the lessons learned about system safety and offers a few best practices in this Let’s Talk Risk! discussion. Listen to the full audio recording of our conversation embedded in this article.
3. Understanding a physician’s view on risk.
Physicians don’t generally focus on the overall risk of the medical procedure, not just the risks associated with a medical device. In a typical procedure, they may use multiple devices. As a result, their focus is more on the treatment outcome while minimizing the overall risk to their patients.
Further, they expect medical devices to be safe and effective in their hands. Once a device has been approved by the appropriate regulatory agency, it is expected to function safely and not be difficult to use.
Dr. Elisha Patel offers a physician’s perspective on risk. Listen to the full audio recording of our Let’s Talk Risk! conversation embedded in this article.
4. Compliance: an obstacle or opportunity?
The general view of compliance is that it is a “necessary evil”, but there is another way to look at compliance as an enabler of innovation. If you consider compliance requirements as benchmarks and/or generally expected performance standards, you can assess gaps in your current performance and strive to achieve significantly better quality, better safety, better security and better sustainability. This can drive your organization to innovate faster and become a market leader.
Raimund Laqua highlights an opportunity to view compliance through a different lens. He recommends the practice of lean compliance that focuses on reducing waste related to uncertainty and seeks to enroll the top management in getting their buy-in for compliance. Listen to the full audio recording of our Let’s Talk Risk! conversation embedded in this article.
5. Collaboration is the secret sauce for success in risk management.
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. That is why a culture of collaboration is needed to establish an effective risk management process.
But collaboration does not happen without deliberate 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. Leaders must consistently model the right behaviors to shape the organization’s culture. 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.
In this Let’s Talk Risk! conversation, Hugo Felix shares insights from his years of experience building collaborative cultures in various leadership roles. Listen to the full audio recording of our conversation embedded in this article.
Connect with Dr. Naveen Agarwal on LinkedIn to be notified of announcements of the weekly Let’s Talk Risk! events.