The mindset that physicians and drug makers will never create cures because that will not gain them money is a very dangerous view to hold. While I cannot say that every doctor and pharmaceutical company is free from corruption, I…   Read more»

I think companies may continue to not follow the rules even if they have a risk of receiving a 483 for the same reason that people continue to speed on highways even when there is the risk of getting a…   Read more»

I think a lot of people have a poor ability to visualize past the present. Those who think quality control is a waste of time and money really only see the fact that they have to pay for quality engineers…   Read more»

I absolutely believe that the FDA is not even remotely too strict. Not to blindly support the bureaucracy, testing, and red tape that comes along with getting a product approved by the FDA, but these steps exist for a clear…   Read more»

Depending on how a device is approved by the FDA, there may actually be less testing involved to get a device approved. For example, 501 K’s allow for devices similar enough to pre-existing devices to enter the market with minimal…   Read more»

As many others have said in this forum, one of the largest issues or difficulties that a doctor will face in trying to make a medical device is funding. Unless they can access or have a large amount of capital,…   Read more»

The first pitfall I could see in outsourcing to a university 1000 miles away is communication. While this is not as big of a problem in the United States, if this experiment was in Europe a university 1000 miles away…   Read more»

I think, due to the sometimes unpredictable nature of research, you don’t really get to always specify if your research is for the present or future. Something that has immediate results can also yield results that can be used for…   Read more»

Testing on animals is a necessary evil. While alternatives do exist, such as in-vitro models, alternatives do not always provide the necessary data needed to prove that whatever is being tested is safe for humans. That being said, there are…   Read more»

In all honesty, determining if missing a milestone is a success or a failure depends on why the milestone was missed. If it was missed because certain tasks weren’t completed in a timely manner or because there were errors in…   Read more»

I have not worked in industry, but project management in academic labs is somewhat similar. I think the best project managers are those who set solid plans while leaving room for error and potential delays. I don’t think it is…   Read more»

Combination devices (if not proven to be substantially equivalent to other products on the market) often require multiple levels of testing and validation before they can be approved by the FDA and given to the public. In terms of managing…   Read more»

I have not worked in industry but I have worked in several labs on campus and went to NJIT for undergrad. If I could go back, I would tell myself to be more amicable to trying new things and reaching…   Read more»

In all honesty, I have really only worked in academia (although I would not define it as, “Working” since I did not get paid and was an undergraduate student). That being said, arguing in favor of either really comes down…   Read more»

In all honesty, I think it should depend on what the student prefers and on what will best supplement their education. Some students have already had a lot of experience in purely academic classes from undergrad, and require less introductory…   Read more»