After watching the lectures from this past week, one of the slides that depicts a comic strip of what a customer wanted versus how everyone in the company perceived the customers request was shown. Th...

In the time period we are currently living in, as many others have mentioned, I believe the most effective ways of getting customers to get engagement with marketing information that they are interest...

Becton Dickinson (BD) Mission Statement: “To help all people live healthy lives” Vision Statement: “Become the organization most known for eliminating unnecessary suffering and death from disease, and...

When i think of a companies that are corporations, I never think of that corporation being specifically an "S-Corp" or a "C-Corp". I just think of them as a corporation, can you please provide an exam...

The major difference between public and private companies, is that public companies have shares that can be publicly traded on the stock market. A private company might become a public company by cond...

For a mid-sized medical device company like you have described (50 people & approx. 10 million in revenue), there are a few benefits that a company like this could get from becoming an “Inc.” vers...

I think there could be many ways to overcome the bad relations that the quality department often has with other departments such as R&D. One way could be to ensure that the quality representative ...

Hello Professor, as someone who works as an R&D engineer and has a lot of experience working with the quality department I can relate to the notion of quality as “burden”. After spending so much t...

I am currently working as an R&D Engineer for a medical device company, and have been for the past 6 years. As an R&D engineer I do have a lot of experience working with the Quality department...

De Novo is a classification process which uses a risk based strategy for new novel devices whose types has not previously been classified. It can be used for devices that would have been classified in...

A product that was recently recalled was the BD Intelliport Medication and Management System Sensor, which was officially recalled by the FDA on January 09, 2017. This product was recalled on its inab...

Based on the research I was able to find the FDA does regulate all cigarettes, smokeless (e-cigs), and roll your own tobacco and these regulations have been in effect since 2009. On August 8th, 201 th...

In my experience in working as an R&D product development engineer in the medical device industry, I would say that projects do generally get pushed to get done quicker due to project deadlines bu...

As many have already said in this thread, both types of research are important and I do not necessarily see one as more important than the other. There will always be a need to solve current societal ...

In my opinion, most of the challenge for project management of medical devices comes from the process (aka Design Controls). Developing medical devices requires a lot of detailed traceable documentati...