ec52 and Sk90, thank you for your responses. The answers you’ve provided about CRO selection criteria, questions to ask when inquiring about them, and selecting at least three to evaluate are valuable insights. Sk90, the data exporting point you bring…   Read more»

I think outsourcing a clinical trial is the most efficient option for a medical device company. In my opinion I think that outsourcing will free up human resources for working on additional projects and ensure that the trial is completed…   Read more»

Tunnel vision can lead to the downfall of a project because you may miss valuable information or indicators while focusing on a single task. I think the best way to avoid tunnel vision is to have an experienced project team…   Read more»

I have gotten the most out of the simulations from this course. They teach you to not only think about a scientific or technical solution to a problem that may arise during a project, but to also think about other…   Read more»

If you are in a weak matrix organization then the functional heads may have more power than the project managers and may dictate who is allowed to be on your project team and for how long. These employees will still…   Read more»

I think that it may be a good idea to put the extra time into thinking about the specifications of a critical component. Yes you want them to be as specific as possible, but if you know during design specification…   Read more»

This is one of those situations where you would need to find the balance between your quality management plan and your risk management plan. You need to satisfy your quality requirements first and then you need to assess the risk…   Read more»

In my opinion I think in a general sense it is better to have negative SV paired with a positive CV. My reasoning goes like this, if you are on a project that is behind schedule with a negative SV…   Read more»

No first hand experience here, but I’d have to agree with Ryan, the early stages of the project are the foundation for the future stages. Im sure small aspects can overlap or melt between two process groups, but it would…   Read more»

I don’t have any first hand experience, but I do understand and agree with why a project should be tracked this way. Your planned value will create a target to aim for by a certain date, the earned value will…   Read more»

I have an example that was thankfully caught by internal QC before any other agency was aware. There was a situation in a diagnostic lab where a new processing technician (non-bench/wet lab position), responsible for accessioning specimen and distributing them…   Read more»

The whole reason why medical devices, or products in general, are created are to fill a users need, and that need will be heavily researched prior to the initiation of the project, think back to the initiation stage. If you…   Read more»

I think that there are some cases where shortening the time frame of a study is a good option. Using the bone void filler syringes from the last simulation as an example, we needed to verify a two year shelf…   Read more»

From our most recent lecture we learned that requesting seller responses and selecting vendors is part of directing and managing project execution. During this phase you are obtaining quotes from approved vendors and verifying them with quality systems depending on…   Read more»

I agree with the above statements, but in addition, missing a milestone is a bad thing no matter how you spin it. Take it as a learning experience for future improvement you may think, but in reality depending on how…   Read more»

I think the best way to avoid an inaccurate estimation is to actually have members on the team that have done similar tasks before, you wouldn’t want to take the opinion of an inexperienced person. This goes to show how…   Read more»

jr377 taking into account how long the built in buffer should be is an important point to bring up. As with all parts of the project this too will be a factor that impacts the budget. The extra time allotted…   Read more»

In my opinion a good way to avoid scope creep is to have a highly efficient planing stage prior to the submission of a final scope statement. Make the most out of each meeting and get all ideas on the…   Read more»

Honestly I don’t think there is a grey area on when to shut down or continue a project with an assessed risk. I think that when a risk analysis is done and the results are shown to the company/stakeholders/sponsors, they…   Read more»

I think that the best way to prevent employees from going off on their own and making decisions that will effect the whole project, is to have a clear scope baseline. As a project manager you should have your scope…   Read more»