Every single task from the moment a clinical trial is conceived to the moment it is submitted to the FDA with complete data as part of a larger submission may be handled by a company or a consultant. There are companies that play every single role in the trial, if you just look hard enough, and most of the time they are rather easy to find.…[Read more]

….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 situation? What did you do right? What could you have done better?

This does not have to necessarily be a medical device project. It can be a…[Read more]

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 the future cash amounts after they are discounted by a specified rate of return.

NPV = ∑ {Net Period Cash Flow/(1+R)^T} – Initial Investment

where R…[Read more]

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 have issues but reading the headlines proves that has yet to happen.

For example, many risk analysis methods, like FMECA, sometimes use a numbered…[Read more]

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 learning here in this course is for large medical device projects that have never been done before. If you are just changing the label on a box, you may…[Read more]

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 the project.

Do you think this is a rigid rule or that there are cases where Verification can flow into the other Processes? Explain.

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 customers think of my product as an afterthought when it was in fact a very specific and detailed portion of the medical device. When they found out…[Read more]

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 integrate with the Project Planning Process.

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 your organization where you work. How would you mobilize these if you had to use them to initiate a project?

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 your organization where you work.

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 you feel you would be most suited for, and why.

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 of Design Validation or not? State your reasons.

1) A diagnostic microscope slide that determines the presence of certain stem cell markers.

2) An…[Read more]

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 may be in development for some time, perhaps a decade. When deciding whether or not to use that material in a device and then putting that into a…[Read more]

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, in real life, they mean several things.

1) Traceability – you need to be able to trace everything you sell back to its source as far as you can.…[Read more]

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 by the Institute of Medicine that basically said we should eliminate the 510K process. Here are two articles about…[Read more]