I too agree with the comments above. The probability of occurrence and the severity of the risk drive the risk values. The occurrence can be frequent, infrequent or occasional, and the severity can ...

Changing design may be cost prohibitive , but sometimes it has to be done, even if it cause financial stress for a company. The alternative is negligence, which can lead to criminal investigations or...

My time tested risk management tool has been brainstorming with a SWOT analysis mind-set. The ability to approach brainstorming honestly and to empathize with the perspective of a customer will allow...

My time tested risk management tool has been brainstorming with a SWOT analysis mind-set. The ability to approach brainstorming honestly and to empathize with the perspective of a customer will allow...

Your question has a lot of depth. As accepting clinical trials “as is” is easy because they have always been done a certain way. It is easy to also conclude that it must be okay because patients pro...

@alexandrabuga Great topic, a nice contrast to typical posts. I do believe that Henretta lics heirs were ultimately compensated – largely due the pubic cries of “foul”, which I believe appropriate. ...

@amd29, I think you're suggesting the multi-billion dollar pharmaceutical industry has little value? Which I would like to agree, but there is strong evidence to suggest otherwise. Pharmaceuticals p...

Yes, I will consider having a partner. Having a partner can be a great thing. Therefore, you must consider what you're will to trade off. It is very important to have it all. Having a partner also...

Medtronic and Boston Scientific are c-corps because they are publicly traded companies with thousands of shareholders. S-corps are really tough to give an example because they are not created with th...

The merit is very limited, and you actually make a really good point. At a minimum, there should be a "time-out" period where comparison to products over a certain age are disallowed. Medical innova...

I think the quality department can become to preoccupied with finding problems, which is not hard to do for any product. Therefore, a collaborative environment must exist so that if problems are loca...

On occasion, I passively thought the two roles were the same. Until I had opportunity to do QC. There is a clear delineation between the two. QA sets the policy and framework, while QC ensures its ...

If you select polymers then you will certainly need implantation, genotoxicity, system toxicity, irritation, sensitization, and cytotoxicity test. Test like these are provided by many companies, and ...

Both leave a legacy, but I tend to agree that I rather see the impact now. Still, who's to say that my research activity will not foster future research, as most science builds upon the work of previ...

@merzkrashed great feedback. Are you a product manager? Some years ago I had the unfortunate experience of being apart of a product launch that was missing the product manager... I'm still not sure ...