I think if I were to start up a company, I would try to go with a structure similar to the divisional market based org structure. As stated in the article, this is structured for a specific niche of market, such as a medical device. Medical devices do not reach out to much of the general market, but for the sake fo the medical market, it would be…[Read more]

I think what it comes down to is essentially the honor system. It may sound quite counterproductive because, of course if you give companies an inch, they’ll take a mile. However, if something during the production of an medical device goes wrong, and the company becomes scrutinized, they are going to be cross examined to see if they truly did go…[Read more]

As I understand it, dealing with risk is split up into three different categories:

Risk Analysis: Risk analysis is simply a definition of risk. Basically, if we do x, y and z may occur.
Risk Assessment: If y and z do occur, what security do we have in place to make sure y and z are taken care of in an efficient manner.
Risk Management: Risk…[Read more]

Yes I was going to mention the SWOT analysis. Preliminary risk assessments are hard to quantify sometimes, so there are many times when the best way to assess each risk is to go back and evaluate what the company has done previously and analyze the risks associated with that project. In a SWOT analysis, the company sits down and reviews something…[Read more]

One really important test is a fatigue tests and heat test. A the fatigue test is essentially a device that will put a certain amount of cyclic loading to the device and will determine how many of those cycles it takes to fatigue. That number is documented and a safety factor is created. Another common test is a heat test which is supposed to…[Read more]

When I was the president of a club during my NJIT undergrad tenure, the secretary of the club introduced the concept of minutes during our weekly e-board meetings. I didn’t really understand the concept of minutes other than just notes being taken. However, she was in a couple of other clubs in which she was responsible for taking minutes. She…[Read more]

The verification refers to the process that deals with evaluating the customer needs and “verifying” that what the scope is focused in on is based on the customer needs. Validation refers to the process of complying with regulations and specifications based on the process of verification. It seems that the verification precedes the validation…[Read more]

Thanks for this post. I think the scope management is the most important, not to say the others are unimportant, but understanding what needs to be done in the amount of time given is the best way to complete an efficient project. There’s nothing worse than having a project with a deadline, getting distracted and working on something out of the…[Read more]

Personally, I think that this topic should be considered with the famous motto “If it ain’t broke, don’t fix it” . Obviously, these documents and the protocol to make all these devices safe and effective are necessary. However, if these legacy products have been used in hospitals, doctors offices, and over the counter for years already, and there…[Read more]