Hello jp582, I agree with the stages that you mentioned. I think it is key that are done the way they are supposed to be. However I think that these steps can compressed to planning, executing and sometimes presenting. The first step in planning would be targeting a market/customer. I have seen some amazing products developed which have not…[Read more]

Hello eac25, you have brought up a very interesting point. I agree that the FDA sometimes takes a long process in order for it to be used in the market. However I also believe that safety is more important than anything in the industry. Putting products which are not capable of doing their task could lead to deaths and also monetary demands…[Read more]

Hello, you have raised a very interesting point. I believe that this cycle happens for all kinds of products. However as you mention, for some of them it’s really hard to see their decline. I think that all products will decline in the market, but that declination will vary in a proportional way to the market’s need. For example: The products tha…[Read more]

Although the example that I will provide is more related to electrical engineering, I hope it helps you understand verification and validation in a better way. The company I used to work for was in charge of a project involving a transformer installation. The client was interviewed by the engineer in charge of the project on what he wanted…[Read more]

This is very interesting. I had never heard of it so thank you for bringing it up. In respect to your question, all biologics fall into the CBER department. The regulation process required for the FDA would be IND, Phase 1,2,3 or pivotal trials and then BLA (Biologics License Application). As Dr. Simon explained in the lecture, in BLA clinical…[Read more]

I think that they are very similar in the role developed, with the only difference that a project manager covers any project. For example: he/she could lead and execute the construction of a building or the development of a new medical device (depending on the specialty of the engineer). On the other hand, a clinical project manager is more…[Read more]

Hello everyone,

My experience in the Industry is mostly in the Electrical Engineering Industry. As I mentioned in my previous post, I work as a Project Manager Assistant. My undergraduate track here at NJIT is Instrumentation, so it has truly given me a little feeling of how the academia knowledge is applied in the real world. This job is a…[Read more]

Hello everyone,

I have worked in a small Electrical Engineering company that sells all kinds electric products such as motors, transformers, solar and wind power generators. The company has a store where customers come in and out, but it also has a Project Managing Section. I worked there for 2 years as a Project Manager Assistant. Unfortunately,…[Read more]

Hello everyone.

As Dr. Simon mentioned in the lecture, the 5 areas of emotional intelligence represent a good project manager. However if I had to add other skills to these 5 areas, I would add strong communication skills and responsible. All leaders nowadays must have strong communication skills because sometimes what matters is not the content…[Read more]

I would never agree with someone using a “verbal agreement” because if you don’t have a written contract of what everyone is supposed to do, a lot of problems will arise and lawsuits might take place, but if have a signed written agreement all these problems will not exist. I have seen people doing business with verbal agreements, but they do…[Read more]

Dr Simon,

At the beginning of the semester, I was not sure if I was going to stay in the class due to having so many courses this semester. But as the lectures started, I understood that this course is not a typical one. I never knew how the Industry works because I am still an undergraduate student. However, whenever I go to job interviews in…[Read more]

Very interesting point lamiaa. I believe that it will be more challenging for project managers to work in matrix organizations because they have cross the limits that the departments set and deal with people that you have never talked to before. Working with your own department means working with those people you are familiar with, so you already…[Read more]

I worked in a small project where the owner of the company was the one who chose the team. The most important criteria used was that they needed to be hands on individuals who executed the project as neat as possible. The ideal team would be one where you have a great relationship and also have the knowledge about the project. It wouldn’t be ideal…[Read more]

In my previous experience, it was more like functional organization. I used to work in a small business where there was a lot of work for a few employees. However, all the projects were done by the same department because there was only 1 department!There was a lot of communication between all the engineers and the work environment was amazing. We…[Read more]

These costs have a bigger impact in those companies that are just starting and don’t have a big budget. Big company have no problem with paying a lot of money for it because they have a big budget. The FDA (I’m gonna use it as an example) uses these expensive standards as a barrier for companies to enter the medical devices field (Which makes…[Read more]

Another good technique that is used in the Industry is: Failure Mode Effects Analysis (FMEA)

This technique analyses the outcomes of a failing project. First you establish the failure modes, then risk reduction is used in order to increase the possibility of the product’s success. So pretty much you delete any failure possibility in the product.…[Read more]