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 c...

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 the...

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 tha...

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 responsibilitie...

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. Howeve...

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 objecti...

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 fundam...

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 t...

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...

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 ...

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 ma...

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 deadlin...

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 capacit...

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...

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, howev...