In my opinion, preventing change fatigue while maintaining a strong change control process in medical device development can be done by teams implementing a prioritization system that categorizes changes by the risk and impact. In my experience in medical device industry, I know that not all changes require the same level of scrutiny. For example, minor updates such as formatting revisions can be fast-tracked. This of course means that on the other hand, significant design or process changes undergo a more rigorous review. I feel that this kind of risk-based approach helps ensure compliance and quality without overwhelming the team members with unnecessary procedures.

In medical device development, it is essential to maintain a robust change control process while avoiding team fatigue, which entails finding a balance between compliance and efficiency. By prioritizing changes according to their risk and impact, teams can avoid treating every update with the same level of intensity, thus alleviating unnecessary burdens. Effective communication about the rationale behind changes and the role of each member fosters engagement and minimizes frustration. Regular check-ins and organized change review meetings can help distribute the workload more fairly. Additionally, investing in change control software and providing training can reduce manual tasks and enhance confidence in managing regulatory compliance. Most critically, cultivating a culture that emphasizes continuous improvement while acknowledging the team's capacity supports sustainable performance. With a thoughtfully designed approach, it is entirely feasible to lessen fatigue without compromising compliance or quality. What strategies has your team employed thus far to mitigate change fatigue, and how successful have they been?

Often times, fatigue cannot be avoided as it is a natural part of the change process. As documentation changes and designs change, it is important that all team members are updated on these changes, and are trained to the changes too if needed. However, as the original post mentions, team members can experience frustration if the changes are frequent. Frequent changes can direct one's attention to a lack of carefulness, laziness, and mistakes. This can be alarming and can be an instigator towards changes, because this can be a stumbling block to the success and timeline of the project. A team can maintain a strong change control process by minimizing these changes by ensuring cross checking and not cutting corners. However, when changes are inevitable or out of the team's control, then it is important to make up the time that may be lost due to these changes, or to adjust the parts of the process affected by the changes.

Changes are a normal part of any project, often arising from shifts in the project environment or risks associated with design controls. These modifications to the control process can significantly impact various aspects of project development, and it is essential that they lead to positive outcomes.
To ensure that changes are beneficial, the first step is to conduct an impact evaluation to understand the reasons behind the change. Following this, it's important to convene with the team to discuss possible alternatives and then engage with management to present a well-informed decision.
Before implementing any changes, it is crucial to maintain the integrity of the project baseline. The scope baseline should be the focal point of discussions, as it represents the approved version of the scope statement, which includes the work breakdown structure (WBS). Any changes should be managed through formal change control procedures. Overall, it is considered best practice for project teams to develop processes or methods that allow them to effectively adapt to future changes.