Although the BoneFix team found an excellent primary supplier (CamTech), they did not sufficiently vet the vendor beyond visual inspection. Smell issues were only discovered after production, when it was late to pivot. Additionally, while they did find a second vendor (UltraMex), leadership’s immediate cost concerns overrode strategic contingency planning. As a result, if the CamTech pouches are deemed unusable, BoneFix has limited fallback options. Contingency vendors are vital, and it is important to balance cost with quality assurance and risk mitigation.
A smart move could have been qualifying two vendors equally from the start, splitting the initial order, or at least conducting parallel risk testing on both vendors. This would have preserved leverage and mitigated potential disruption.
In high-stakes projects, how do you convince management that investing slightly more upfront in contingency planning can prevent massive downstream costs?
I think management needs to realize the importance of risk management and enacting contingency plans. Whatever can go wrong will go wrong. This is not to have a negative view on everything, but instead taking precaution in project development. Yes, you may be spending more money and time in the beginning, but it avoids a huge potential headache down the road. Contingency plans reinforce the idea that the project will continue even if problems do occur. If there are no contingency plans in place, you are spending a lot of money and time when the problem occurs. Management might as well cover all of the risks from the start.
Also, highlighting the cost of setting contingency plans versus the cost of problems arising with no contingency plans in place could be a huge benefit. I think reality would sit in with management and help them come to terms that contingency plans are necessary to avoid massive downstream costs.
In high-stakes projects like medical devices, I think one of the best ways to convince management about investing in contingency planning is to speak their language: risk vs. cost analysis. Instead of just suggesting a second vendor as “extra caution,” you can show the potential financial impact of a major failure—like unusable inventory, regulatory delays, or loss of customer trust. For instance, with BoneFix, the cost of the 10,000 unusable CamTech pouches and the possible disruption to product relaunch would likely be far greater than the cost of qualifying two vendors from the start. Making this comparison visual, such as through a simple risk matrix or cost model, can make a huge difference in convincing leadership.
I also believe it's important to frame contingency planning not as an “insurance policy” that might never be needed, but as a competitive advantage. Companies that can quickly pivot when issues arise stay ahead of their competitors and protect their reputation. Instead of framing it as spending more money, I would present it as protecting the project timeline, ensuring smoother launches, and reducing emergency costs later. Management teams are much more receptive when they see contingency planning as part of maintaining control rather than reacting to chaos
One way of convincing management to invest in more contingency planning is to remind them that it is a regulatory and compliance risk. If the primary supplier cannot meet quality standards post its approval, that can cause major delays in FDA reviews or can even force a product hold, risking reputational damage and market share loss. There would be more at stake than just a costly failure. Having a second supplier ready can demonstrate how flexible the company is when confronted with sudden failures, giving the company the option to switch smoothly if something goes wrong. To better present these ideas, running models like Time-to-Recovery (TTR) Supplier Risk Scores can help to quantify how huge a problem it would be to the company if a supplier failed. How can teams build risk metrics into early stage planning to make supplier decisions not a reactive decision, but rather a proactive decision?
We can follow the below strategies to convince management on investing more,
1) Define risk adjusted costs: When planning for a project, we often think of cost as just the money we’ll spend. But risk-adjusted cost isn’t about extra or unnecessary spending—it’s more like a safety net. It refers to the amount we allocate to protect the project against potential risks we’ve already thought through. Instead of seeing it as overspending, we should treat it as a smart way to be prepared for what might go wrong. It’s part of responsible budgeting.
2) Identify risk: The first step in dealing with risk is to figure out what could go wrong. Once we've listed the possible risks, we have to work on converting qualitative risks into something more measurable, like estimating how likely they are to happen and how much damage they might cause. There are many methods to do this: SWOT analysis, surveys, brainstorming, interviews and checklists. It's also super important to involve the team and stakeholders early, since they often have insights.
3) Communicate to stakeholders: Once the risk is identified and analyzed it should be communicated to team members and stakeholders. The goal is to make the information easy to understand, so visual tools like graphs, charts, or simple diagrams can really help. This way, everyone can stay aligned and work together toward solving or preventing issues.
4) Past experiences: If there have been similar issues in the past we can put forward that in front of the management to convince them. For example, if a previous project had delays because no one accounted for a certain risk, point that out—it helps make the argument stronger.
5) Real world example: Other companies who had failure due to lack of contingency planning can be good examples for the management.
6) Parallel run: Run both the vendors parallel, camtech and ultamex. This kind of “parallel run” lets you compare their performance in a real-world setting without risking everything on a single choice. It’s a practical way to reduce risk while gathering valuable data.
7) Focus on key areas: Not all risks are equally critical. Prioritize the contingency plans for critical business areas. Involve all the teams research, engineering. Obtain buy-in from key decision-makers and ensure that everyone understands the importance of contingency planning.
You make a really good point. In projects where the stakes are high, it’s so important to show that spending a bit more upfront on contingency planning isn’t a waste; it’s smart risk management. A good way to get that message across to leadership is by using real examples, like what happened with BoneFix. Trying to save money in the short term ended up causing bigger issues later, like delays and limited options when things went wrong. Another helpful approach is to lay out a simple cost comparison. Show what the impact would be if the primary vendor failed versus the cost of having a backup ready to go. When you put the numbers side by side, it’s easier to see how the small investment early on can actually save time, money, and stress down the road. It’s not about being overly cautious, it’s about being prepared.
In the development of medical devices, contingency planning is quite important when supplier issues, regulatory changes, testing failures, or clinical delays quickly throw budgets and schedules off. A well-developed contingency plan helps teams to overcome unforeseen challenges without sacrificing the overall success.
One major advantage of contingency planning is reduced risk. Early detection of high-impact, high-probability hazards—such as delays in regulatory filings or critical component shortages—allows teams to create backup plans, assign buffer resources, or pivot actively.
One of the frequent challenges is underestimating the pace with which little issues could develop. Teams without contingency preparations could make reactive, expensive decisions compromising compliance or quality. Including contingency planning into the general project plan guarantees teams stay flexible and strong under demand.
How effectively should one prioritize which hazards call for backup plans? Should teams concentrate exclusively on the most likely and high-impact hazards or ready for every conceivable situation?
