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tn58 replied to the topic In the Shoes of a Project Manager in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
If I was a project manager for this week’s simulation in a real life situation. I would get in contact with everyone from day 1 so there is no falling behind. I would make a WBS and assign parts of the simulation to each person in the team. For example, every single person would be asked to do their own research and bring their findings to the team. This way as a project manager I can organize the information and assign each person according to their level of understanding and expertise on the subject. This is very critical. If we look at the simulations, many team members wait until the last day to respond and this kind of delays everyone else in the process of making the all of the inputs are correct and we aren’t rushing to meet the deadline. This ensures we submit a quality simulation and each team member should gain knowledge from the simulation. This can only happen if each member in the team has to research the project and then discuss their findings and then as a project manager I can assign each person with a specific task. For example, someone with the most relevant and excellent literature findings would be asked to find more details regarding a device. On the other hand, someone with a more technical understanding of the project would be asked to manipulate protocols where all the conditions are met. And someone who is more focused on the product on the market would be given the task to evaluate similar devices on the market and their records.
But all of this can only be done with time management. As a project manager, I would make sure if a team member is not able to deliver a task in a timely manner than maybe it is time to reconsider someone else for that task because we would be on someone’s time and we do not want to end up in money issues. For example, we are unable to complete the simulation and deliver but we also wasted money and time of the company.
And to the answer your question. I think this would fall under class II devices because animal testing is required.