Validation is the process that guarantees the product quality that the end user expects. The design must provide that expectation with a process that can be consistent with that expectation as well. ...

Medical devices must be safe and reliable. With data from the FDA that states that "44% of voluntary recalls from October 1983 through September 1989 may have been prevented by adequatedesign control...

As with many things in medicine and healthcare it looks good on paper. In action is where the ethical dilemmas present themselves. On one side there is a huge opportunity to advance medicine in real...

Experience is always valuable. That is even more important in clinical research. There is huge liabilities that are present when conducting research on human subjects. I can understand why experien...

I live in a country where many people believe that we should have the right to choose. Choose to own a gun, choose to say what we want, choose to vote; the quote life, liberty, and the pursuit of hap...

I taught an entrepreneurship class for a summer camp we did for our students. In that class we watched a video on how Coca Cola was started. At the time there was differentiation in branding among c...

@jafar The fact that the fate of the business is not connected to any individual owner upon there death is extremely important. The flexibility with ownership makes comfort in longevity a lot easier....

At this time I would start an LLC. I would start an LLC because it is cheaper and easier to start. An LLC will still provide the legal protection that I would need when operating a business. I woul...

I have not worked in a regulatory project but I have worked in government inspections and enforcement. My first experience in the field was in zoning code enforcement. I was responsible for enforcin...

QA/QC in relation to ethics can present interesting dynamics. I can go back to my college job as a cashier at Home Depot. We were asked to meet performance measures of timeliness, accuracy, sales, a...

If I was to simplify the difference between quality control and quality assurance, I would say that QA puts systems in place that supports the creation of a quality good or service. QC refers to work...

@llefevre This is a very interesting topic. Companies can't be innovators and pioneers if they have not mastered the other needs outlined in the pyramid. It makes me think if that is true. If we lo...

I have not personally signed a non-compete agreement. It seems as though in biotech that it would almost be a necessity. With the success of biotech organizations directly related to innovation, it ...

The type of organization that works best is the one that maximizes management effectiveness. My preference is a matrix organization. The matrix organization has a lot of benefits. I believe it prov...

If I were involved with a medical device development project, biomaterial selection would be important. Choosing the right biomaterial is important for project success. Biomaterial selection involve...