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»

Using the information about EV, PV, and AC, I think could pose a risk if it is not paired with any other form of analysis. EV, PV, and AC are surface level ways of telling you that the project is…   Read more»

Organizations can strike the right balance between maintaining control and allowing flexibility for creative problem-solving and adaptation by incorporating quick responses from the CCBs. Agile review on these potential changes helps expedite the process during project development. It would prove…   Read more»

I think a great approach to fix the potential problems from each extreme side is to incorporate two ways of communicating informational updates. For information that does not require questions and in depth talks, it can just be put into…   Read more»

I think project managers can strike the right balance between providing enough information without overwhelming stakeholders through two methods. The first method would summarizing the updates effectively. Sometimes the parties involved in the project do not need every exact detail…   Read more»

I think the biggest challenges in achieving scope verification are managing the communications between all team members and stakeholders in the project. Scope creep is the result of missing or lack of communication between people involved in the project. A…   Read more»

Using an agile and stage gate hybrid approach would require checkpoints throughout the project timeline. This keeps all the personnel in the project in line with the project goals. Also, the team can pivot quickly to fix an issue with…   Read more»

A major strategy to ensure that all stakeholders stay aligned is by everyone acknowledging who is responsible for certain tasks in a project. Tools can be used in parallel like a Gantt chart and a RACI (Responsible, Accountable, Consulted, Informed)…   Read more»

I think the best answer definitely depends on the overall size of the project. In this case, I feel like a liaison assigned to FactoSet could work since the project is not as complex. This is just one person and…   Read more»

Medical device projects definitely should utilize cost estimation effectively and efficiently. A way to do that is investigating a project that was highly similar to the current project you are working on. Medical device projects deal with FDA regulation procedures…   Read more»

A Work Breakdown Structure (WBS) is definitely a useful tool in a project, especially when it comes to medical devices. Most of what I am about to say definitely depends on the size of the project since the complexities of…   Read more»

These certifications are definitely useful in building your resume and marketability. Employers will be more keen in hiring someone with more project management knowledge and experience. The Google PMP is a newer certificate available on a more broad scale to…   Read more»

Early start (ES) and early finish (EF) can be helpful in scheduling flexibility and resource planning. In terms of scheduling flexibility, ES helps the team know the earliest date the task can start and helps prepare for the task that…   Read more»

Gantt charts can be a useful tool in all stages of designing a medical device. Pros of using Gantt charts is that they identify which tasks have slack and which tasks are on the critical path. Tasks that have slack…   Read more»

Keeping all these details in mind, I think a balance of both perspectives can be valid depending on the product and the function of that product. Mimicking worst case scenarios helps combat Murphy’s law as much as possible. It is…   Read more»