For my capstone project, I found it very important to log every step of the process, Even the small details and changes I made to the entire thing. My team and I started was one intention to the design and ended up with a lot of changes that we sometimes forgot that we made and if we hadn’t written all the details of the changes we would have been…[Read more]

I agree with previous comments about what the overall Engineering Change order is the flow of it and how it is beneficial. Since these comments mostly covered the essentials, I would to alternatively add to the discussion the side effects that engineering change orders may add. The process is crucial they can cause a major delay to the project and…[Read more]

I agree with dag56. It is very important to keep potential options in the project manager’s mind until it is time to pick for all of the reasons he mentioned. I would like to add that not only in the supplier’s side but the project changes are also something to be considered. Within companies’ planning process changes occur all the time and it is…[Read more]

there is a huge range of different challenges that project managers could face. Since a lot have been mentioned, and I have read other posts, a major unforgotten challenge was mentioned in one of the other posts. The challenge is having members of a team that don’t take their responsibility and acting unprofessionally. Dealing with a team member…[Read more]

I understand and for the most part agree with both your posts but on the other hand, I have had a personal experience where personal ties to project members with the project managers allowed them to unprofessionally think that it was okay to have a certain behavior. So I would like to add to personal relationships that professional wise the…[Read more]

to reflect on your experience as I had a similar one, where the project I was working on depended on another sector to hand us some chip that will allow us to obtain a signal for us to analyze. Research was definitely a key to avoid this delay, but as you mentioned it is not always the only way to avoid such problems. However, there should be…[Read more]

I am not really quiet sure how missing a milestone would lead to any success. I agree with other that it greatly depends on the importance of that specific milestone to the project. However, i can’t imagine how having it being called a milestone from the beginning doesn’t eliminate that it from the possibility of being not important. On the…[Read more]

This is my second course with dr. Simon. I previously have taken Medical Devices Development (BME684). The amount of information I learned about the paperwork and all the requirements to carry a project in real life. This has encouraged me take this course as well. Although there is some overlap between both courses, I keep learning new and more…[Read more]

I agree with you jp582. Relying on others can be problematic. An interesting concept that I had learn from my previous class with dr. Simon, was that the entire department in real like examples is responsible for the shortcoming of one of their members. Do you think that is true for all teams ? or can it be troubling in smaller companies where…[Read more]

During a class project, we missed one milestone it delayed the entire project and we had to move faster in other milestones to accommodate for the time lost. The project was an eye tracking device and after accomplishing most of it we realized that a major test in our test plan had failed due to the missed milestone which has significantly delayed…[Read more]

This is a very important topic to discuss. The work breakdown structure caught my attention when I was listening to the lecture. I have had many projects where communication and time conflict has been a major issue. However, having a successful project was always implemented with two key concepts, the breakdown of work, and scheduling due dates…[Read more]

I agree with all of the above however I would like to add that in certain cases where similar products exist in the market, if the project team spends so much time in that phase it might take longer than needed. By the time the project is ready to initiate, the market gap it had to fill might be taken over by some other company or a project. A…[Read more]

I agree with what everyone had to say about the consequences of a budget cut. However, I believe that is it very important to understand why the budget is being cut. If it is an overall organizational cut then as mentioned above, the project manager need to evaluate how the budget will be reassigned regarding what is left to carryout a successful…[Read more]

I agree with everyone’s post. However, I believe communication and the ability for the team to work under pressure is a key to a successful team. You can form a power team of expertise with different backgrounds, but their ability to work and synchronize together is very weak. Every team member should have the open mind to adapt to other views and…[Read more]

I completely agree with Chaudhry.

According to an article I read regarding the Fitbit regulations decision with FDA, it said that, “According to FDA, the general distinction between a general wellness product and a medical device is whether the product makes a medical claim”.

the fitbit is clearly not intended for medical claims. It doesn’t…[Read more]

I completely agree with Chaudhry.

According to an article I read regarding the Fitbit regulations decision with FDA, it said that, “According to FDA, the general distinction between a general wellness product and a medical device is whether the product makes a medical claim”.

the fitbit is clearly not intended for medical claims. It doesn’t…[Read more]

I strongly agree with you that cutting them in the first place will cause a lot of of other risks. I believe that for those terminally ill patients maybe they should make an exception to specifically approve this certain medication with limited regulations for those individuals. While it is can be temporarily approved for those patients it should…[Read more]

This is a great topic for discussion. Accelerating the process of FDA regulation seems like an ideal solution for many critical patients. Although it seems appealing, I believe that it will cause a lot of risk in terms of the safety of those accelerated products. If we turn to go that way and loosen up the regulations, I believe we have to do a…[Read more]

My experience with design controls so far was another course I took with Dr. Simon. The class idea was to come up with a project of a medical device and go through all the paperwork and official documents that implementing a real project would require. Every part of the design controls was emphasized and utilized to implement the “project”…[Read more]