Adding to what Hiren Rana said, not only will the project manager need to allocate more time for R&D. The test protocols may need to revised. This would take more time and causing a delay in the tasks down the line. If the test protocols are changed, than some changes in the paperwork or times of certain tasks may also have to be changed. This…[Read more]

Sharing my research experience, I was doing a computational study on the BCR phili gene. The entire research project was broken down into multiple parts: Computational Data, Analysis, Literature comparison, and finally presenting my findings to a committee in order to complete the requirement for my undergraduate graduation. After collecting the…[Read more]

I think Verification can occur anytime during a project. I do not have any industry experience but theoretically speaking Verification can occur at any point. It can also occur during the research phase where making a change in your project is a lot easier versus the execution phase where it would require a lot more changes in your timeline and…[Read more]

In designing a hip stem implant and running finite element analysis on it last semester. After creating the part file which took hours, and applying constraints and loads on the hip stem implant. After running 20 analysis to predict where our implant will fail, a very critical detail was left out. The threshold of a software and bugs in a…[Read more]

Not knowing your budget can limit your team members. For example, when you hire people for a project they work at a specific rate. So if you do not know your budget it can be problematic in getting the team members you want. So if you know the budget, you can timeline your project much better and hire the team members according to your budget. In…[Read more]

My opinion on this is, SOPs should not be required during the research phase. The main reason behind this is that during the research phase your project can take multiple phases. There could be second opinions or alternative ideas involved during the research phase. So there wouldn’t be any benefit in involving SOPs and considering them during…[Read more]

Agreeing with everyone here, in addition I would say the SOPs should be written so someone with a high school education can read them without any confusion. Also, it varies from project to project. Some projects require a lot of detail while others you can cut down on the detail. Some projects may be very complicated and a step by step detailed…[Read more]

I do not have any work experience in this field. However, from what we learned so far. I would choose the second option you posted. Reason being is the work instructions step. This is vital in any Quality Management System as it can reduce many errors in the later steps. The advantages for the first would a similar version which enlists the…[Read more]

As everyone already answered the initial question in full detail. I would like to add why I believe it is important to have post market surveillance. Yes it gives companies feedback and how to better future products or if a defect is detected, then how to recover. But data collected during this surveillance is what matters and how that data is…[Read more]

I personally take women’s one day multivitamin as recommended by my doctor. During undergraduate years, I was going through extreme stress and anxiety with college courses as well as work life. This resulted in loss of appetite and dehydration and lack of certain vitamins in my body. This one pill actually helped me get back on track and regain my…[Read more]

My personal experience as a coordinator of a program at NJIT (non-medical).

I would prefer a team who actually is passionate about the project. As a coordinator, I am responsible for 50 students and 6 tutors. My entire project depends on my tutor’s ethics, time management, and their reports. If I do not not get a report within a certain time…[Read more]

I have no experience in the industry, but based on what I know about ECO from Dr. Simon’s course, I would only use an ECO for profits. For example, if there is a major change that needs to occur in the device or protocol, yes by all means submit an ECO. However, one of the main reasons If it was my own product, I would use the ECO if the device or…[Read more]

Initiating a project idea is the hardest part of project development because if done incorrectly, your project will fail and you will waste time and money. So how would one avoid this? This is where business and market research play an important role because it requires getting to know the full 3D view of what your project will be competing…[Read more]