One really interesting point made in this week's lectures relates to who classifies as a stakeholder. For example, I was under the presumption that a stakeholder had to make some time of monetary cont...

This was definitely a surprising component of this week's lecture series. Although I agree with many of the previously stated points in this feed, I do think that there could be benefits from keeping ...

I think this is an interesting question because there are probably general trends relating to the expected project timeline based on the type of medical device. It would be interesting if there were s...

Although it is important for a project manager to strategically manage the expectations of stakeholders into achievable goals for their project teams, the stakeholders are really the primary foundatio...

It's definitely difficult to come up with exact cost estimates of a project. There are always unexpected changes or hurdles that present themselves and alter the initial project plan. However, I think...

One of the important points brought up in PMBOK Ch.3 was that effective project managers (PMs) should possess both leadership and management skills. They specifically define leadership as: directing a...

In most cases, I feel that it's critical to meet the project's goals by the deadline. Especially in larger organizations, where other departmental progress may be contingent on the project timeline of...

In accordance with what was stated in previous posts, misclassifying a medical device would definitely alter the time course of the project and its release to market. If the medical device is classifi...

Of course, it ultimately comes down to personal preference. Some people thrive in smaller groups and some in larger ones. Just as an interesting tidbit, I remember learning in my psychology class that...

Being a project manager entails a host of responsibilities to both the larger organization and to the employees under them and, in my opinion, it takes a unique kind of person to do this. I was fortun...

One really critical point brought up during the video lectures/MiniSim was the importance figuring out what kind of device will be developed and its intended classification (Class I, II, or III) from ...

While the classification of medical devices does depend on the level of risk the device poses to patients, its designated classification really depends on the mechanism of action. For example, if the ...

The classification of medical devices can definitely be uncertain and especially unclear when it comes to combination products. It's another component that needs to be accounted/tested for, so I think...

The size of a project team really depends upon the goal at hand. I agree with many others in the comments that a smaller groups is more manageable, accountable, and productive than a large group where...

To expand on your second point, relating to the challenges of satisfying regulatory requirements of novel devices without a clear classification, this is definitely a gray area and can be especially d...