An NDA and a patent both help protect ideas, but they are not substitutes for each other. An NDA is a private agreement that keeps information confidential between the parties involved. It only works ...

If you’re asked to sign an NDA, the main thing to remember is that you should never sign something you don’t fully understand. An NDA is still a legal contract, so you should read it carefully and mak...

A verbal/oral agreement is essentially the same thing, both mean an agreement made through spoken communication. Verbal agreements can be legally binding, but the biggest problem is proving what was a...

If I had to choose, I’d prefer working in a matrix-based organization as well. It offers the best mix of both worlds: the deep expertise of functional teams and the clear goals and accountability of p...

Successful Scenario (Strong Matrix)A medical device company launches a new imaging probe. The project manager controls all budget and timeline aspects and decision-making authority but R&D and QA ...

Medical device companies need to change their internal operations because healthcare organizations now use value-based care models which require them to focus on patient outcomes instead of device sal...

I definitely believe risk management is an important part of the planning phase. It’s not a waste of money or time. In fact, it often saves both in the long run. Identifying potential risks early help...

It’s important to look at hazards and hazardous situations separately because they happen at different stages of risk. A hazard is something that can cause harm, while a hazardous situation is when so...

A real example of this happened during the 2014 Ebola outbreak, when healthcare workers in West Africa faced serious exposure risks. The hazard was the Ebola virus present in infected patients’ blood ...

I think risk acceptance means recognizing a risk but choosing not to take any immediate action because the potential impact is minor or the cost of controlling it is too high compared to the benefit. ...

Yes, I definitely feel safer knowing that validation and verification are key parts of the medical device development process. The process verifies that all devices fulfill their design requirements w...

Risk management operates together with design verification and validation to detect all possible hazards which get evaluated and managed from start to finish during medical device development. The act...

Medical device development needs design control as its fundamental requirement to confirm that products meet safety standards and quality benchmarks and user requirements. Design control systems that ...

The placebo effect creates difficulties in clinical trial result analysis because it demonstrates how mental factors can affect actual physical health results. The brains of patients who receive sham ...

Researchers use various approaches to minimize placebo effects while confirming that their results show the genuine effects of treatments. The most common approach is blinding. Single-blind studies pr...