....and not always for the better. Using what you have learned in the Scope Management lecture, what situations have you encountered where a project suffered from scope creep? What did you do in that...

Net present value is the calculation that compares the amount invested today to the present value of the future cash receipts from the investment. In other words, the amount invested is compared to th...

Depending on the project, a number of different risk analysis methods are available, but like anything, none of them are perfect. If one of them was, the product that used that method would never hav...

Keep in mind that in this course we are teaching the ideals of project management in a medical field. This is the best it could ever be, and more than that, this type of project management we are lear...

When comparing Project Management Processes to Design Controls, I laid out a diagram that synced them up roughly. On that diagram it shows that Verification takes place during the Execution phase of ...

Everyone who has worked on a project has a story where a critical path was somehow delayed for varying reasons. As someone working in the hydrophilic coatings industry for a while, I had a lot of cust...

In this course we have not discussed other tools such as Six Sigma, but they can nonetheless be important components for project planning. Explain your thoughts on how a Six Sigma process would integr...

Project Initiation requires several things, as per the lecture, and two of them are enterprise environmental factors and organizational process assets. Give some examples of each as they appear in yo...

If you currently work in Industry, tell us what kind of organization you work with, i.e. whether it is a functional, matrix, or project-based one. If you do not work in Industry yet, tell us what kind...

Take a look at the lecture where it talks about Design Validation. In your words, what is Design Validation? In the following examples, do you think that the device would need a clinical trial as part...

One of the unsettled discussions in smaller companies especially is when to move on from abstract talk to actual planning and laying out a proposal. Consider a technology like a new biomaterial which...

Another important aspect which often overlaps with Regulatory: Good Manufacturing Practices (GMP's) What are GMP's? Many of you can google things and bring back links, I'm sure, but in practical terms...

One "fun" thing to talk about during the Regulatory lectures is the ongoing soap opera of what is happening to the 510(k) process. One of the key events in the saga was a controversial report issued b...

How do you think Project Management differs in different industries or different types of Project? If you are a great PM for doing Medical Device Projects, does that mean I can throw you into a softwa...

Some of you taking this class might work in industry already, and not necessarily in the medical device field either. Whatever industry you work with, share some of your experiences about the followin...