I would generally disagree with restricting what a private company (independent of the government) could charge for its products. It is the companies right to charge whatever they want and it is the choice for someone to agree to pay…   Read more»

I believe your average engineer does not need to worry about a company being either public or private in their work. In theory, much of the work at both types of companies would be the same. While their scale, funding…   Read more»

In short, yes. Starting in 1886 with Santa Clara County v. Southern Pacific Rail Road and about a half dozen United States Supreme Court decisions over the past ~100 years, it has been established that corporations are to receive the…   Read more»

I can see myself working in the QA/QC process. I think the requirements for such a role should not be that stringent. Often times biomedical engineers will fill these roles but the job responsibilities involved can really be completed by…   Read more»

Without a doubt QA/QC is the most important aspect of the medical device development process. Of course, there would be no quality control if there is no R&D or product development process. However, a product idea is just that, an…   Read more»

I would believe the first step is to have a centralized system for all control documents. As a company grows, some divisions update their internal procedures more frequently and with different objectives than others. Over the course of just a…   Read more»

As some have said before me, I don’t believe we should “speed up” the approval process. I am sure there are areas which can be done more efficiently and move an approval along more quickly, but fundamentally the review of…   Read more»

Precision and accuracy are essentially different ways of saying effective and safe. When something is precise you achieve a more predictable result. In terms of medical devices, if a 100 trials show that heart valve works perfect for only 6…   Read more»

I feel in principle the 510k approval process makes a lot of sense. If you want to improve upon an existing device that has already shown to be safe and effective, it would be excessive to undergo the the full…   Read more»

I don’t believe it is unethical to test on animals. With that said, the testing being performed on animals must be fully thought out and made with good conscious. I don’t believe its ethical to treat animals with experiments as…   Read more»

I would prefer my research to have a direct impact in my lifetime, more so to “see the fruits of my labor”. However, I believe more often than not any discoveries or contributions to science I will make won’t be…   Read more»

I believe it would incredibly dangerous to cut corners in research and then use poor results to then sell a product. It is counter-intuitive to comprise the integrity of your results to meet a deadline becase in doing so you’re…   Read more»

I believe that the transition to a virtual environment has improved project communication. While some aspects of virtual work have existed prior to COVID-19 they certainly did not exist in the capacity nor the efficiency that they do now. It…   Read more»

I believe one of the best ways to estimate task duration is to find a similar project that accomplished the same goal to understand that if the conditions were the same the task should be completed in the same amount…   Read more»

Challenges in project management for medical devices would be the rules outlined by regulatory bodies. Many people have mentioned that the FDA imposes the greatest challenge to project managers, however I would add that the FDA equivalent in other countries,…   Read more»

@sfrancis I had the same idea at first glance of the question. Being underqualified allows for a bigger gap of where you “should” be and gives you a clear objective to work towards, something that I really appreciate. However, my…   Read more»

@srp98 I agree largely with the points you have made but maybe for different reasons. I would prefer to have a hybrid work schedule and after my internship this summer I’ve gathered that almost unanimously people do NOT want to…   Read more»

@ridmehta I agree with a lot of your points especially that there should be more than 5 practical courses to choose from. Where I disagree is in the ratio, I believe a 70/30 of practical to academic classes should be…   Read more»