For long-term goals in order to remain an established company, going public is almost a requirement in my mind. A private company when it goes public ...

Negative cash flow is definitely more influential than profit itself when evaluating when companies fail. Getting to a negative cash flow indicates nu...

One critical factor which could be overlooked with "extremely" innovative technologies would be the payback period. Payback period is the length of ti...

Some of the communication troubles between QA and QC because integration of the two is tricky due to the nature of how they deal with quality. QA focu...

Adding on with a specific example of incomplete documentation missing which leads to a failed audit is the lack of "assumed" process in the documentat...

Specifically when comparing QA/QC in the development stages of medical devices versus in the post-market surveillance, companies should adapt their st...

I agree that engineers should have a layer of responsibility for regulatory basics. Understanding of FDA regulations is important for proper design of...

I do think that if a reform is needed on the classification of medical devices in the FDA, the time to do it should be in the near future before too m...

I agree with the opinion that smaller startups should focus more on innovation than compliance since it can give them a good product to stand out. Thi...

Starting research on time in industry is realistic, but fully completing research on time is less realistic. The deadlines in industry are often there...

I do agree with the next step for pre-clinical research before testing on humans is the substitution of animal testing with computer simulations, but ...

The choice between novel and tested materials ultimately comes down to balancing the benefits versus the risks a company is willing to take to gain fr...

Over-planning sounds like it would lead to a more straight-forward project, however it could complicate risk management processes. While meticulous pl...

As you mentioned, projects may not go exactly as planned, especially in medical device projects. A lack of organization can mean that a project fails ...

I would say that the biggest obstacle in projects is making sure everyone does their fair share of work. Disagreements can be solved through discussio...