I believe that the consultant was in violation of an NDA or CDA, especially if this was not agreed upon by the other company he used to work with. I think this is also why it is necessary for companies…   Read more»

Hey Roberto, Good question. I think although it is too restricted, it is necessary. In my opinion, if two people are out to discuss business, then only the individuals involved should be there. There is no reason to invite a…   Read more»

Hello Dr. Simon, I really enjoyed this course. In fact, it was probably the most useful course I have taken at NJIT, only because it is the only course explaining what the different career options are for BME students and…   Read more»

Hi kdg4, You brought up a really good point. I agree that one of the hardest parts for a project manager is choosing individuals for their team in a matrix-based organization. However, I also see that as a benefit. Assuming…   Read more»

In my opinion, it depends on the goal of the company, as well as the size. A small company may function best as a functional organization. That way, every employee has their own department focus. A smaller company may not…   Read more»

In my opinion, it is always best to work with someone who is most knowledgeable about the task they will work on. While maintaining good relations with people in the workplace, you do not always need to “like” someone necessarily…   Read more»

I would have to disagree with most people on here. These regulations should not cost any money. There should be a standard set of rules that all companies should follow, similar to the way the FDA has guidelines for medical…   Read more»

Hello, This is an interesting article. While I do agree that yes, companies can make these common mistakes, it still does not hurt to follow a process. The article mentioned that risk management is looked at as a “checkbox” activity….   Read more»

Other factors would also be the probability of the occurrence; degree of harm caused by the failure; number of individuals affected and how exactly the failure affects them. Also, I wanted to add that it really all comes down to…   Read more»

Human factors/usability engineering focuses on the interactions between people and devices. For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and…   Read more»

Meeting minutes are important because specific points can be made in a meeting that are important in moving the project forward. If we overlook those points or tasks, it could cost the team the quality and deadline on finishing the…   Read more»

Hey Roberto, I agree with what everyone on this thread has said so far. However, I would also like to add that when “making up tests” it is often beneficial to read up on publications that have done similar clinical…   Read more»

These products, although no longer under development, as you mentioned, are still being manufactured. If this is the case, then there exist documentation in order to create the product. I do not think it will be too difficult to use…   Read more»

In my opinion, if you were to write a document on how to make a device, and give that document to someone else, they should be able to build an exact replica without coming back to you for questions. This…   Read more»

Hey Lamiaa, Good discussion question. I agree with all of the points on here. I just wanted to add also, that for a medical device, not following design controls can result in severe safety issues. It can cause numerous medical…   Read more»