I would personally like to have my end goal to be a manager, but I first would want to get a couple of years working as an engineer to understand how the industry actually works. This semester we learned many…   Read more»

No, I’m not so surprised by these results and kind of expected it. As Confucius put it, “Choose a job you love and you will never have to work a day in your life”. For someone to enjoy working for…   Read more»

The rate of return is specific to a company and it is related how the company gets its funding for projects [1]. Moreover, it is the rate of return that the investor expects or the cost of borrowing money [1]….   Read more»

My capstone project AudIQ was about to suffer from a small scope creep, which is when the changes, continuous or uncontrolled growth in a project’s scope. Before the development of the mobile application, we had laid out our customer need…   Read more»

My capstone project was one that we were not sure if it would even go through FDA regulation. My capstone project is a mobile application that helps train users to discriminate auditory cue, such as discriminating pitch. We were also…   Read more»

I took apart in a mock design review meeting for my senior capstone course. In my class, we were assigned roles of the scribe, moderator, reader, and authors. A couple of weeks before the design review, each of us had…   Read more»

Some methods that a project manager can develop in order to properly account for employees underestimating task duration are one holding weekly meetings towards the end of the week to check on the progress of the project. This ensures if…   Read more»

Some tasks that I would need to perform to obtain an accurate assessment of quality assurance of my project is to make sure thorough research has been done on the project. I would also have to make sure that work…   Read more»

I would have to agree with you. I’m an undergraduate BME student and this is my first time taking the course with Dr. Simon. The only time learned about FDA regulation was in BME 304 Introduction to Biomaterial course with…   Read more»

A medical device is my capstone project, AudIQ, which is a mobile application that trains people with hearing aid’s auditory cues. One possibility of risk of the product is the application does not control the level of sound it outputs…   Read more»

A time when an extraneous task suddenly wound up on the critical path for the project is the discovery of Scotchgard stain repellent. Patsy Sherman, a researcher, who worked at 3M company as a chemist was assigned to work on…   Read more»

Verification means to check if the inputs and outputs are equal to each other and to verify each output with a verification protocol. To an extent, it is a rigid rule that Verification takes place during the execution phase of…   Read more»

The necessary regulation to get FDA approval of a combination product is first the company has to request for designation (RFD), in which companies have to outline the rationale of the product. Then, the company has to submit the “pre”pre-investigational…   Read more»

One of the critiques the IOM said about the 510 (K) process was that it lacked the legal basis to be reliable of the safety and effectiveness of moderate -risk class II devices. The reason why the 510(K) lack safety…   Read more»

The kind of organization I feel that I would be most suited for is project-based one, which an organizational structure when a company’s department and personnel are organized around a particular project. One of the main reason is that I…   Read more»

I think project management differs in different industries is in terms of regulations involved on a project. For instance, projects in the biomedical industries need to take into consideration the FDA regulations, such as 510(K) clearance. While construction site has…   Read more»