Risk management lessons learned from running the Boston marathon
Insights from a Let's Talk Risk! conversation with Christopher Gehring
Note: this article highlights key insights gained from a conversation with Christopher Gehring 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:
Planning is essential for success
You need a team to help you achieve your goal
Slow down and take a step back when things don’t go as planned
You can plan for contingencies but there will always be surprises in the real world
We need to be both agile and detailed in our approach
Planning is essential for success
Boston marathon1 is one of the most prestigious running events in the world. Runners from all over the world aspire to run Boston at least once in their lifetime! But it takes a lot of hard work and preparation to even qualify to enter the race. That is why good planning is absolutely essential.
Similarly, good planning to essential to achieve success in your risk management activities. A risk management plan2 is a key requirement of ISO 14971, the international standard for application of risk management to medical devices.
Chris took a risk-based approach to his training by setting up his primary goal of simply finishing the race without getting injured. He hired a running coach and a strength and conditioning coach who helped him develop a 16-week training plan and key milestones to achieve along the way. He paid attention to his nutrition with the help of a dietitian and worked hard to maintain the training volume each week. He monitored his progress each week and applied a flexible approach to handle any contingencies.
A good plan has sufficient details of different activities, assigned responsibilities and a method to review progress against planned objectives.
You need a team to help you achieve your goal
Running is a solo sport, but even then you need a team to support you in achieving the ambitious goal of completing the Boston marathon.
As noted above, Chris established a support structure by hiring a running coach, a strength and conditioning coach and a dietitian. He also joined a running club where he could get support and encouragement from fellow runners, who could also keep him focused on his goal.
Similarly, risk management is a team sport! It needs a team of cross-functional experts and a culture of collaboration to complete different activities in the risk management process. It also needs top management support to establish, to provide adequate resources and to review progress.
Slow down and take a step back when things don’t go as planned
Murphy’s law says that anything that can go wrong, will go wrong!
Even though Chris had a good plan, and he followed it diligently, he still experienced a hamstring injury during his training. He adjusted his training slightly and still decided to enter the race. After all it is Boston and you don’t give up on the opportunity too soon!
Halfway through the race, he began to experience painful cramps which forced him to slow down considerably. By the time he reached the heartbreak hill3, it was nearly impossible to run and he had to walk to the top, at which time a surge of adrenaline fueled him to run to the finish line. While he missed his 4-hour target by 15 minutes, he still managed to finish the race , which by itself is a huge accomplishment!
The lesson here is that no matter how much you plan, you will encounter challenges and surprises during execution. It is important to slow down, take a step back and analyze the situation. In this case, Chris followed his training and race pace early on, maintained good hydration but realized that he should have built a little more endurance by running longer distances during training. This insight will prepare him to adjust his training for a better outcome next time.
You can plan for contingencies but there will always be surprises in the real world
As noted above, Chris had a good plan. He had considered mitigation strategies for different contingencies including hydration and fueling up during the race. But he had not considered experiencing cramps halfway through the race.
We cannot plan for all scenarios. Many times we don’t know what we don’t know. We need to be as complete as possible but not be paralyzed by over analysis. We have only finite resources and limited time. We can use prior experience from a variety of sources to guide us, but we also have to keep moving forward and execute the plan.
What is more important is building flexibility in our plan to change course if needed. We need to also monitor our progress at planned intervals and adjust our approach. This becomes even more critical in the post-market phase where we must quickly analyze new information and take timely action. We should also take time to consider lessons learned to improve our risk management plans for future products.
A best practice is to consider the lifecycle management side of our risk management plan. Risk management activities have to continue throughout the lifecycle of our medical device. Our plan needs to anticipate some of these activities in the post-market phase to make sure we will continue to have sufficient resources.
We need to be both agile and detailed in our approach
There is a strong focus on regulatory compliance in the medical device industry, including a heavy emphasis on documentation. Often, this approach gets in the way of speed needed for rapid product development in today’s hyper-competitive environment.
If we look at the winning times in Boston, they are generally around the 2h mark, not the 3-4 hours that most runners take to finish the race. Those who win the race have both speed and endurance, not one or the other.
If we want to win, we need to be able to be both fast and detailed in our practice. Agile does not mean we don’t document our work; or focusing on documentation does not mean we can’t be agile. We have to do both. Of course, it is not easy; but neither is winning Boston. But if we aspire to be leaders in the industry, we have to find a way to build a dual capability. We need both sprinters and long distance runners on our teams.
Agility is the outcome of a disciplined approach that combines rapid cycles of experimentation and learning with a rigorous and well-planned validation. Each phase of the product lifecycle requires a different balance between agile and traditional methods. It is challenging to strike the right balance, but by trusting our teams and building a culture of collaboration we can achieve success.
About Christopher Gehring
Christopher Gehring is currently a Principal Design Quality Assurance Engineer at Insulet Corporation. He has over 15 years of industry experience with core expertise in design controls, risk management, system engineering, quality management systems and continuous improvement. He holds B.S, and M.S. degrees in Mechanical Engineering, a Professional Certificate in System Architecture and Engineering, and a Graduate Certificate in Business Administration. He is also an ASQ Certified Quality Engineer, Certified Quality Auditor and Six Sigma Green Belt. In his spare time, he enjoys running, sailing and music.
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.
Boston marathon is an annual marathon organized by the Boston Athletics Association.
See Clause 4.4 in ISO 14971:2019
Heartbreak hill is a steep ascent of nearly 0.4 miles between miles 20 and 21 on the Boston Marathon course. It is known to be a significant challenge for most runners including those competing at the professional level.