I am currently a first year graduate student and this is the second class I have taken with Dr. Simon. I took Medical Devices Development (BME684) last semester and I enjoyed that class so much that I decided to take…   Read more»

While the pros and cons of each organizational structures are covered pretty well in the lecture, I will go over it for the sake of the discussion. The first type of organizational structure was the functional organization. The pros were…   Read more»

This is honestly not an easy question in my opinion. If someone is introverted and quiet, their team may see this as the manager being withdrawn and impersonal, as well as a poor communicator. Personally, I think it is important…   Read more»

If I had to choose a project team, I would want members who are eager to learn and grow as well as passionate about the project that needs to be done. While it is important to have people who are…   Read more»

Project Management will definitely differ from job to job. I don’t think you can take a great project manager from medical device development and throw them into a construction site or a software building company. This is because these different…   Read more»

Initiating a project idea is the hardest part of project development because this is the part where a rough outline of everything is required. You need to provide an outline of what the device does, when the device will be…   Read more»

I believe there are a lot of skills that are important for a project manager to have in order to succeed. Mainly, communication skills and time management skills. I think it also depends on what you consider successful. Success could…   Read more»

I believe that your app should be considered a mobile medical app based on the definition you provided. I believe this because, you said that your app allows it users to “retrain their auditory cues” and identify which frequencies can…   Read more»

I love this question because I have always thought about this. Personally, I believe the system is backwards. If I am going to school to be an engineer, my value should be placed on my ability to engineer what is…   Read more»

Due to COVID-19, its becoming increasingly more difficult to get ahold of people when you really need them. Personally, I’m the type of person who typically doesn’t like to overdo phone calls and emails and things like that. Fortunately, I…   Read more»

The difference between a patent and a NDA is that a patent is a federal document proving ownership of an idea, while an NDA is a contract between two people. In other words, NDA’s recognize the people whose signatures are…   Read more»

This class was extremely informational. I really enjoyed the amount of different topics we delved into. During undergrad at NJIT, I feel like the only course that really introduced me to industry-related topics was capstone, since it involved working on…   Read more»

A verbal contract can include any agreement with words, which includes both oral and written agreements. Because of this, we should compare written contacts to spoken contracts. In every sense, a written contract is the most reliable contract when starting…   Read more»

In my opinion, it is tough to say which organizational structure is best and which one is the most effective. I believe it depends on the type and size of company that is being used. If they are the same…   Read more»

For high severity risks, I would choose avoidance since that kind of severity of the risk is high any way to completely eliminate these risks would be necessary. For low severity risks, I would use mitigation or acceptance if the…   Read more»

This is tough because the important word you used was “residual”. These companies do all they can in the risk management to avoid having these risks out there. Unfortunately, there is only so much a company can do to a…   Read more»

This is a great question. In terms of medical devices, I feel like there are a lot of examples of devices in which we need to accept the risks. For example, as stated in the lecture with surgical tools, we…   Read more»

While similar in many ways, Verification and Validation are used to check different components of a device. More specifically, verification checks that all inputs are equal to their corresponding outputs. This is done through making a test, doing that test,…   Read more»

So I do not have much experience with meetings and meeting minutes so I can only speak theoretically. I can definitely see why documenting meeting minutes would be important. There are instances where some people may not think you are…   Read more»

I believe every part of the DDP is very important in their own way. However, if I had to choose one to be the most important it would have to be the scope management plan. I chose this because it…   Read more»