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 the clinical details and rules. As dag56 mentions, a clinical project manager is a more of a unique I would say more specialized and…[Read more]

I agree with past three posts from my classmates. 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 the clinical details and rules. As dag56 mentions, a clinical project manager is a more of a unique I would say more…[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 is considered significant risk device if it meets any of the points in this list provided by FDA. Here is the list

“• Is intended as an i…[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 classification of what to be considered a mobile medical app and what not. The first link has the types of examples…[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 and interact with the project manager freely rather than feeling that he is the boss. It will ease communication between the…[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. However, the knowledge necessary for another industry is crucial. As someone mentioned in a biomedical engineering…[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 team based on the project needs. They can bring resources tailored to that specific project from anywhere in the entire…[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 some cases of long-life friends who conducted businesses together based on the relationship trust, but at some point influences…[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 and people go out of limit with them. When you give someone a really expensive gift or treat them in a…[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 course, since it gave me a very detailed insight of how the industry works and I get to experience it through the project. I…[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 and competition. As the lecture mentions, the matrix organization can shift the resources in a bigger organization. This is really important…[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 the organization which promotes innovation. It can be difficult for the project manager to assemble the…[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 devices.

https://www.clinicalkey.com/#!/content/journal/1-s2.0-S107663321400186X

– Lamiaa Abdelaziz

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 the ones you mentioned.

here is a quick list and the link is listed below for more details:

* Understanding…[Read more]

Hello Roberto,

I have done some research like my classmates, it was interesting to read that the FDA points out to verification not only in terms of tests. They list guidelines such as analysis and inspections. I agree with my classmates that they don’t have a specific list, but they provide major explanation and overall explanation of how to…[Read more]

Hi

I don’t have an experience with them, but I can imagine if they don’t exist how hard is it to implement a change or realize when a mistake is happening. If you don’t have a review meeting after every important milestone in the process of the device development, then it will be really hard to process a change. As mentioned in the lecture,…[Read more]

Hello Roberto,

This question is very interesting. Many people overlook the importance of meeting minutes. Meeting minutes are very crucial to industries such as medical devices. Things like important dates and details that someone might have not heard, or a crucial point made about the product might have been discussed and reported in those…[Read more]