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 should hit the ground running. As in, the company ...

Negative cash flow is definitely more influential than profit itself when evaluating when companies fail. Getting to a negative cash flow indicates numerous poor financial decisions; it is never the r...

One critical factor which could be overlooked with "extremely" innovative technologies would be the payback period. Payback period is the length of time estimated to break even from the development of...

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 focuses on being more proactive, while QC is more reac...

Adding on with a specific example of incomplete documentation missing which leads to a failed audit is the lack of "assumed" process in the documentation. In cases where employees work at a company fo...

Specifically when comparing QA/QC in the development stages of medical devices versus in the post-market surveillance, companies should adapt their strategies in a way which makes the process quicker ...

I agree that engineers should have a layer of responsibility for regulatory basics. Understanding of FDA regulations is important for proper design of medical devices, but with constantly changing gui...

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 many problems arise in classifying "in between" med...

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. This lets them develop opportunities for receiving fu...

Starting research on time in industry is realistic, but fully completing research on time is less realistic. The deadlines in industry are often there to demonstrate that progress is being made to sha...

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 in reality I don't think this will be happening an...

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 from a market. Materials that are already proven are...

Over-planning sounds like it would lead to a more straight-forward project, however it could complicate risk management processes. While meticulous planning could account for many risks, there is alwa...

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 to pivot quickly enough to address issues, delays,...

I would say that the biggest obstacle in projects is making sure everyone does their fair share of work. Disagreements can be solved through discussion, and more than likely a solution will arise. Whe...