I think that the priorities and goals of QC/QA are different enough that they should be separated, but both teams should work with each other. Both teams can bring their knowledge and expertise to the table when designing a product….   Read more»

@justinwilliams On the topic of Johnson and Johnson during COVID-19, a conflict I remember arising during the pandemic was J7J’s vaccine for COVID. This vaccine did not go through the normal FDA process of approval and instead went through the…   Read more»

I think often, regulatory is often viewed in a negative light, because the engineers who are creating these medical devices probably don’t like hearing numerous rules that restrict their ideas. It might feel like regulatory just comes in to control…   Read more»

I think that regulatory professionals should be involved from the very beginning of the design process. By being involved early, engineers who are designing the medical device can get a clear understanding on what the regulations are and adjust their…   Read more»

A negative consequence that comes with animal studies for pre-clinical testing that hasn’t been discussed is the cost. As seen in the 2 animal study protocols posted on Canvas, getting animals for the study are very expensive. Additionally, many animals…   Read more»

From your discussion, I was able to learn about NAMSA, which I previously had no knowledge about before. According to their website, they help with “market research, preclinical studies, clinical trials, biological safety testing, regulatory submissions, and much more”. I…   Read more»

I agree with the points mentioned above about why it is financially safer, since using materials already in the market have a stable supply, reduces costs and times, and prevents financial downfall in the future. However, I think it is…   Read more»

I think it is very important to spend time planning details of a project before getting started. I don’t think a lot of time should be spend on it and not every detail can be planned out, but there should…   Read more»

I think one way to effectively strategize is mentioned in this week’s lecture about earned value (EV), planned value (PV), and actual cost (AC). Earned value is the value of the work that has been completed, planned value is the…   Read more»

I agree that organization, communication, staying calm, motivation, and being a team player are all important traits that make up a good project manager. Another trait that I think is important for a project manager is delegation. A good project…   Read more»

This summer, I was made aware of how a large medical device company is actually being financially hit due to tariffs as released in their Q3 report. Also another reason for their financial loss was because their second biggest market,…   Read more»

In order to be a good professor, I think there are a few different traits that a person might need. As someone who is a student in the biomedical engineering department, I noticed that a common issue in a lot…   Read more»

Hey Raina,  In regards to your question about which one is more fulfilling, I think that academia and industry work can have an equal impact in different ways. I agree with your point about how academia is important because the…   Read more»