I agree that the QA professional should probably have the final say, but I also think the disagreement itself shouldn’t just be ignored after the decision is made. If the AI keeps identifying something that the QA person doesn’t see,…   Read more»

I think there should be an easier path for novel devices that are clearly lower risk. I understand being more cautious when there isn’t a predicate device to compare it to, but at the same time, being new doesn’t automatically…   Read more»

I think your point about how strict “substantially equivalent” should be is interesting. Something else that made me think about this differently was the reading for this week. If a new device is cleared based on a predicate, and that…   Read more»

I can see your point that Regulatory Affairs represents the company when communicating with the FDA, but I don’t know if I would separate protecting the company and protecting patients that much. I think in a regulated industry those two…   Read more»

This is an interesting question because I don’t think there is ever a point where researchers can say they have eliminated every possible risk before going into human trials. To me, the decision is more about whether enough evidence has…   Read more»

Having worked in manufacturing previously, I believe in addition to cost, equipment and timeline, I might consider how much control I want to have over the research process. Being in a highly regulated industry has helped me to understand that…   Read more»

I believe both passion and funding are equally important; however, I do not believe that it is necessary for academia and industry to compete on who contributes more to each of them. To me, they represent different stages of the…   Read more»

I think technology can definitely make project management easier, but at the same time, I feel like it really depends on how people actually use it. From working in manufacturing, I’ve realized how important communication and documentation are when different…   Read more»

Working in pharmaceutical manufacturing has made me look at this question a little differently. I agree that patient safety should come before meeting a deadline, but I also don’t think the decision should simply be between “keep going” or “stop…   Read more»

I agree that a strong initiating phase can prevent a lot of problems later, but I don’t think it can prevent everything. One point from the lecture that stood out to me was the importance of talking to the people…   Read more»

I can say that I am more attracted to industry now because there are many possibilities of growing my career and discovering various roles. As for me, one of the main reasons why I want to go into industry is…   Read more»

Your concept of non-invasive continuous glucose monitoring seems to me an excellent example of an idea where improvement of the medical device does not necessarily include additional functionalities but rather the elimination of the factor that complicates the patients’ experience….   Read more»

Absolutely, I agree with your perspective. While both industry and academia can have their impact on society, it will be absolutely different. Given that I work in CAR-T manufacturing right now, I would say that experience in industry definitely changed…   Read more»