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…   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…   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…   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…   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…   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…   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…   Read more»

I agree with Krp, Pineda and dag56′ posts. I would like to add that although they are similar in the main functionality, I would say a broader project manager is going to face a harder time getting accustomed to all…   Read more»

Hello Roberto, This is a really interesting point. I had that question come up to my mind as I was watching the lecture. With some research I found a clear answer to that concern on the FDA website. A device…   Read more»

I agree with my classmates that your application that you designed for senior project should be classified as a mobile medical app. I couldn’t access your reference link, but I found two links by the FDA that completely breakdown the…   Read more»

I believe that a good skill that a project manager should have is giving other team members the spirit of acting as team players in the role of project management. They should have the limited freedom to express their inputs…   Read more»

I have read opinions from other classmates and I agree and disagree with each one of them at different points. I agree that project management basics of being a good leader and other similar skills are uniform in any industry….   Read more»

I don’t have any experience in the industry yet. However, I feel like a matrix type organizations is more appealing to me. I feel it like it promotes challenge and creativity. Matrix organizations have the ability to sort out the…   Read more»

I agree with everyone who mentioned the importance of a written agreement, and I agree with your point Roberto. The only part I would like to comment on is about the condition you set for verbal agreements. I have seem…   Read more»

Hello Roberto, Very interesting topic. Although the example you mentioned might be humanely absurd, but I agree with my classmates. The restrictions are highly important. I come from a country where these kind of gift are not restricted at all…   Read more»

When I signed up for this course, I was expecting, as others have mentioned, more of a theory content about medical devices. When I looked at the syllabus and attended the first meeting, I was even more excited about the…   Read more»

I agree with you that this type of organization is good for a start up. on the other hand, as the company grows overall I would prefer to have a company that operates in the matrix way. It promotes innovation…   Read more»

I would like to work for a matrix type organization. Matrix type seem flexible to the changes in its environment. Those types of organizations can shift focuses and resources toward major problems and products. It creates a challenging mood in…   Read more»

Hi, I agree with Irene on using quantitative methods. I found a good research paper on using this method in medical devices. The research says that the method is widely used in pharmaceuticals but it goes over its benefits in…   Read more»

Thank you for sharing this! I agree with you. It is a very interesting read. I was researching more on the topic and found another link that lists possible ways on using risk management efficiently and avoiding problems such as…   Read more»