I think a way project teams ensure that they measure relevant metrics is to focus on measurements pertaining to regulatory demands, validation and verification milestones, and risk management. Also, making frequent measurements can help monitor performance in these areas of…   Read more»

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…   Read more»

The project manager needs to take into careful consideration all areas of management as aforementioned. This can be accomplished with careful documentation and assessment of every area. There needs to be a change control process that tracks every change in…   Read more»

This can be a tricky question for many project managers. Often, the argument hiring internally is that familiarity with the company. This is familiarity with all aspect of the company, including people, processes, documentation, and product. Therefore, there would be…   Read more»

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…   Read more»

Organizations can balance control and flexibility by implementing a structured yet adaptive change management process. This involves clear criteria for categorizing changes based on risk and impact, ensuring that low-risk modifications undergo a streamlined approval process while high-impact changes receive…   Read more»

Though both are types of verification, scope and design controls verification are quite different. They take place in different project phases and address different things. Scope verification ensures that the project’s defined deliverables meet stakeholder expectations and requirements, confirming formal…   Read more»

In order to ensure that past project insights lead to real improvements, it is important to continuously track and categorize lessons learned. Tracking this throughout a project rather than leaving it until the very end would reduce the chance that…   Read more»

To develop a team effectively during the execution phase, a blend of personalized support and group alignment is essential. One highly effective approach is providing continuous, context-specific training—delivering learning opportunities that directly correlate with the current project phase or specific…   Read more»

Balancing effective communication and productivity stands as one of the toughest challenges in project management. Excessive meetings can consume valuable time and energy, distracting individuals from focused tasks, whereas inadequate communication may lead to confusion, repeated work, or missed deadlines….   Read more»

To ensure that insights from past projects lead to tangible enhancements rather than being overlooked, teams must integrate lessons learned into their project life cycle. A practical approach is to connect these lessons to the planning stage of upcoming projects,…   Read more»

The initial step involves formally evaluating the request through a structured change management process. This includes thoroughly documenting the proposed change, grasping its rationale, and assessing its effects on project timelines, budget, resources, and quality. The project manager should then…   Read more»

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…   Read more»

I would take below steps if the customer requests changes to the project scope after the execution has started.   Understand the change in detail and document the request formally, including specific modifications, reasons, and urgency. Conduct an impact analysis…   Read more»

@sa2847 I agree with you! On top of this, project managers can also manage their inboxes more efficiently by setting specific times during the day to respond to emails. I personally enjoy utilizing filters and folders to organize my messages….   Read more»

The success of a project largely depends on the closing phase. This phase is critical for generating insights that can lead to new ideas for improving or evolving the final product. Future project teams should gather insights from past projects…   Read more»

From a medical device intern’s perspective, I believe that hiring from within the company is often the better choice, especially for roles that require deep understanding of internal processes. Many tasks, even for the same role at different institutions, have…   Read more»

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…   Read more»