Why risk practitioners must build the empathy muscle
Insights from a Let's Talk Risk! conversation with Christie Johnson
Note: this article highlights key insights gained from a conversation with Christie Johnson as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.
Empathy is defined as the ability to understand and share the feelings of another1.
Why - you may ask - should risk practitioners care about empathy? After all, risk management is all about managing uncertainty as objectively as possible. How does exercising the empathy muscle help risk practitioners do a better job than, let us say, focusing more on data analysis and regulatory requirements?
As we have discussed frequently on this platform, risk management is a team sport. It requires working collaboratively with subject matter experts from different functions such as Engineering, Manufacturing, Clinical/Medical, Quality and Regulatory. We cannot do risk management alone in a silo. We have to work with people to come up with the best solution at any given time using the best available information at that time.
When working in a cross-functional team, we have to pay attention to every individual’s unique perspective. Instead of pushing our own way to achieve quick results, we need to first allow different perspectives to be shared openly without judgment. In fact, diversity of viewpoints in the team is our best resource to make sure we don’t have any blind spots during risk analysis.
This is the essence of empathy. To listen carefully so we can truly understand the other person’s viewpoint. We don’t have to agree or disagree. But it is very important to make sure we enroll everyone so they are able to contribute fully, and we arrive at the best outcome as a team.
In this conversation, Christie points out that exercising empathy is even more critical in a small startup, where speed to market is the main focus. Risk management may be seen as a barrier when we focus more on documentation and less on helping to build a safe and effective device, while also optimizing the total cost.
Here are a few key points that emerged from our discussion:
Understand that not everyone shares the same enthusiasm for risk management. Engineers often view it as a paper exercise, mostly for regulatory purposes. They are more interested in problem solving and building the medical device. Working on risk management activities takes time and money, and there is no prototype they can hold in their hands.
Risk practitioners need to first achieve full commitment of their entire team for the common goal by focusing on patients and users of the medical device. Risk management does not start with getting everyone in a room to work on an FMEA!
Recognize that everyone looks at risk differently. Risk perception influences how each one of us understands and evaluates risk. By exercising empathy, risk practitioners can help develop a common understanding of risk in the context of the use of the medical device.
The end goal of risk management is to deliver a safe and effective product. It involves a lot of judgment to evaluate the benefit-risk balance of the medical device. A common understanding of both benefits and risks is critical to evaluating benefit-risk.
Empathy is a leadership skill. It requires us to focus on people first, and results second. We have to be open to listening carefully, without judgment. We have to share our own stories and feelings openly to inspire others to engage in a similar way. If we do this right, we bring the best out of our team.
About Christie Johnson
Christie Johnson is currently a partner at Prodct, a boutique advisory firm to support early-stage biotech, medical device, diagnostic and therapeutic companies throughout product development and commercialization activities. Guided by a solid knowledge of ISO 14971 risk management, she helps create effective strategies for quality, regulatory and manufacturing, while also providing direct execution support including resource augmentation when necessary.
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.
Source: Google dictionary box when searching for the phrase “empathy definition”