To start, I think a project manager should reinforce and emphasis the original scope. Depending how long the project is, maybe some personnel forgot the details of the true scope. This is the first action to correct unforeseen problems. Address the problem head on with factual information. There should be no pointing fingers since that will just increase tension between team members. The project manager should express the effects of the unforeseen problem whether it be time and or cost. 

I think it is very important to be 100% truthful to the project team and propose different options to remedy the issue in the best way. A project manager should be incredibly confident in there social skills and their abilities to pivot when a problem comes up. This will help communicate the new reality of the project without everyone feeling that things are falling apart. 

Small projects in medical device development can grow out of control without warning if risks are not properly managed. Scope creep often occurs when new features or requirements are added without proper evaluation. Early underestimation of complexity can cause timelines and costs to balloon as unexpected technical challenges emerge. Regulatory demands can change or become more complex, forcing additional testing or documentation that was not initially planned. Supplier delays or failures can create bottlenecks, especially when alternative vendors are not identified early. Poor communication among stakeholders can lead to misaligned expectations and duplicated efforts. Inadequate resource planning can result in critical shortages of skilled personnel when the project expands. Unclear project goals can cause teams to drift from the original objectives, adding unnecessary tasks and features. Rapidly changing market or technology trends may pressure teams to adapt the project midstream, increasing workload. Failure to update the risk management plan can leave the project vulnerable to growing issues. Without strong project controls and regular reviews, even a simple project can spiral into an overwhelming challenge.

The Project Manager can address the situation by undertaking the following actions:

1. Clearly Understand Requirements: Ensure a thorough understanding of the project requirements, as there is no margin for error due to the stringent deadline.
2. Engage with Business Stakeholders: Conduct discussions with business stakeholders to identify the minimum essential requirements needed to minimize potential losses within the available time frame. Additionally, determine the maximum permissible delay that would not compromise the overall project deadline.
3. Coordinate with the Project Team: Engage with the project team to review availability and clarify requirements, ensuring that workloads are managed appropriately to prevent employee burnout.
4. Explore Alternative Solutions: Collaborate with team members to identify any alternative approaches that may help address the issues more effectively.
5. Develop a Contingency Plan: Establish a contingency plan to safeguard the project's success in the event of unforeseen challenges.
6. Implement Agile Methodologies: Break down the project into smaller, manageable tasks and consider adopting Agile methodologies to ensure that each incremental step is completed correctly and efficiently.
7. Optimize Resource Management: Refer to the resource management plan to identify and allocate any additional resources that could support the achievement of the project's objectives.

In BoneFix's scenario, uncertainty arises in the performance domain, leading to a lack of understanding and awareness of issues, events, paths to follow, and solutions to pursue. This unpredictability brings the risk of not knowing future events, which can contribute to volatility in the present moment. As a project manager, it is crucial to first identify the root cause or causal relationship behind the project's process failure. Once this is established, project managers should pursue solutions that can create potential new parameters. By recognizing uncertainty as an opportunity, project managers can work to minimize project delivery issues without significant negative impact, effectively reducing cost and schedule reserves to align with project objectives.

To communicate the new reality without seeming like the team is losing control, a project manager should frame the update as a proactive response to unforeseen challenges. Briefly explain the original scope and the new issue, in this case the odor and material concerns, then outline the impact on timeline and resources. It’s important to emphasize that reassessing now is a strategic move to mitigate risk, ensure quality, and prevent larger setbacks. Presenting clear next steps or options shows that the team is managing the situation decisively and maintaining alignment with project goals.

I think it is important to maintain proper communication and be transparent of the current issues. A project managemer should approach leadership with a plan on how the team will mitigate the challenge. A plan shows that the team is prepared and is working on how to not only solve the unexpected issue but also prevent it in the future. If there is a significant change in the scope, time, or budget of the project, it is important to be transpareent about that and align all stakeholders. In the case of this simulation, the issue was from an external source. The team did order samples before placing the bulk order to ensure the pouches were correct. However, the odor was more of an issue with the vendor's processes. In this simulation, there was an additional delay and cost because of the unusable pouches from the bulk order. This should be brought up to leadership. Additionally, an issue from internally within the company should be taken more seriously.

If scope, resources, or risks aren't properly managed from the start, even small projects in medical device development can quickly spiral out of hand. Originally a little design update or limited feasibility study, what begins as a time-consuming, resource-draining project without clear direction could develop into something else totally.

One common cause is scope creep or the addition of new features, testing, or compliance requirements without reviewing budgets or timetables. A small adjustment to a Class II item, for example, can trigger further verification, document corrections, or even regulatory re-submissions—all of which add startling complexity.

Another challenge is undervaluing interdependent relationships. Changing one component could influence manufacturing methods, testing processes, or software validation, therefore generating a set of unexpected tasks. Strong project controls enable teams to maintain perspective of priorities and stop resource burn-through.

How best, in your view, to ensure that small projects stay under control? Should teams rely on experienced judgment to decide when to follow official change control processes or escalate even for little projects?