This is a really interesting topic to discuss as this type of situation often happens in a workforce. During my co-op experience, I was a part of the huge transfer project in which my company acquired another small medical device…   Read more»

During my work experience, if we need to file for 510k or FDA approval, we use the flowchart developed by the company and the FDA to guide us during the entire process. The process is so broad that there are…   Read more»

In my past experience with project, it is very hard to see the complete process as they are very detailed. I have seen a project follow the normal process of, Initialing, planning, Executing, and Closing. However, I was mostly involved…   Read more»

I agree with most of the participants regarding product recall due to a device failure. Product recall is the worst thing that can happen to a medical device company. It can affect the business assets, the people involved and the…   Read more»

Engineering change order (ECO) is an official change notice that one initiate upon seeing something wrong in the process or if there is a documentation discrepancies in the engineering drawing. After the initiator fills in the necessary action, it then…   Read more»

In my senior design project (capstone), we were supposed to come up with an estimated project cost and track as we progress with buying parts for the project. Just like in any project, our budget varied throughout as completion of…   Read more»

During one of my co-op experience, I worked with the design and instrument validation of many measuring devices. As a result, I was involved keeping critical notes on file because validation of a device is not something that can be…   Read more»

I agree with most of the participants above regarding the issues that may arise while the project manager is out on a leave. These issues are very common in the industry and the project team must get adhere to. As…   Read more»

I agree with all the participants in the posts above regarding the role of PM and his or her duties of Quality Assurance. Quality Assurance responsibility is a huge task within Quality in a medical device industry. Few tasks that…   Read more»

One challenge that the project manager face on a daily basis is the ability to properly communicate the deadlines of multiple projects. There are many active projects going on in a company. Many times, the project manager doesn’t have the…   Read more»

During project planning, cost estimation and time estimation for completing a project is the most challenging task for the project manager. There are many of factors that can affect the project manager in making these decisions. Sometimes, it’s the end…   Read more»

I agree with all of the participants in this post regarding Dr. Simon’s class. This is my first semester as Masters in Biomedical Engineering and also first time taking a class with Dr. Simon. In my bachelors at NJIT, I…   Read more»

This is a really interesting topic to discuss. I understand your point that missing a milestone in a project means company loses money, bad reputation etc. However, this is not always the case. I believe it really depends on the…   Read more»

I agree with all the participants that the project timeline and the scope depend on the type of the project. For example, if it’s the same project the company has already done in the past, then it will require minimal…   Read more»

One of the crucial projects going on while I was in my co-op was to manufacture the knee implant. The project manager had broken down in several phases including validation, testing, cleaning, and packaging. This was the first time for…   Read more»

During my capstone project, we created a Gantt chart using Microsoft Project to guide us and better visualize the timeline of the project. In the Gantt chart, we divided the project into three parts, thinking, designing, and testing and allocated…   Read more»

In my opinion, I believe verification can occur at any phase during a project. It all depends on the kind of project and especially in medical devices, verification is a must step after each operation during manufacturing. Verification can also…   Read more»

Most of us have experienced a critical path situation during the senior design capstone project. We were designing a product that monitors blood glucose, heart rate and activity that securely transfers data to a remote server. All the data is…   Read more»

I agree with the above posts that budget cut is very common problem that most project managers deal within a company. In the planning stage of the project, most project managers create a Bill of Materials (BOM) and an estimated…   Read more»

This is a really interesting topic to discuss as situations like this often happens in the work force. One of the biggest advantage of meeting in person is that one can convey his or her idea without any problems or…   Read more»