I believe that MDD and AMDD have been essential to my coursework here at NJIT. I am currently working in manufacturing engineering at a medical device company. In the manufacturing department of a medical device company, it is all about…   Read more»

I appreciated going through the simulations each week. It was a more hands-on experience of everything that the course has been teaching through lectures. Using my current industry experience, I have been able to suggest logical solutions. In the opposite…   Read more»

I am not personally involved in the clinical aspect of medical device development. However, in the future I would like to at one point be part of this process as it seems to be very interesting. In the previous course,…   Read more»

Executing a clinical trial can take large budgets to complete. To compete with this, companies tend to use developing countries as their regulations are less strict or even non-existent. The location of these trials makes a difference, however. For example,…   Read more»

If the subject were to undergo unexpected outcomes and no longer wants to take part in the trial, it is up to their discretion to continue or to end their treatment. Informed consent includes consent throughout the entirety of the…   Read more»

With management, it is important to be open to communication while still maintaining a high level of respect. It is possible that since management is so far removed from the lower levels of the chain, they are blind to the…   Read more»

Non-conformance can occur at any point in the production process, and this does not always indicate the need for a CAPA. A non-conformance for a singular unit of the device can just indicate a minor human error from an operator….   Read more»

In my experience, a correction can also be called a rework in which the product is fixed for a nonconformity. In the medical device industry, this would mean fixing the medical device before it even leaves the production floor. For…   Read more»

Depending on how established the company is, GMPs may be constantly under appraisal in order to refine them. The changes can range from a minor difference in recording something to entirely modifying the system in place for the company’s QSR….   Read more»

The purpose of CAPAs is to ensure that the product is up to the highest consumer standards. The preventative actions are required to foresee every possible negative outcome. These preventative actions are used to anticipate what can go wrong and…   Read more»

Internal audits are essential to medical device companies because this creates a controlled environment in which the company can comprehensively evaluate how they are doing in terms of their Quality System. Internal audits are less variable than one from a…   Read more»

During the maturity phase of the product life cycle, it is important to be FDA and EU compliant. This product is now on the market and is used for real people. These FDA and EU guidelines are in place to…   Read more»

Since the development phase of production is one of the most expensive parts of production, I think a company, depending on their resources and priorities, should consider killing the project. This can vary from company to company, for example a…   Read more»

It is essential to have both accurate business knowledge as well as good interpersonal skills. This comes from any point of sales in any aspect, everything from clothing retail to medical device sales. In order to first develop a bond…   Read more»

I find that the development phase can be the more expensive phase as not every investment made during this phase will ultimately have a pay off or even lead down the path that the company wants to go down. This…   Read more»

There is always a push and pull between keeping companies as is, and moving forward towards innovation. In my experience, there has always been individuals that have been in place for so long that they lack the motivation to change….   Read more»

I have had experience with obsoleting product in my company that had been cumbersome to carry as a product. These were product that had not been making the amount of money that was worth the cost of production. The undertaking…   Read more»

It would vary with each company, but even if the equipment does not go through the entire validation process again, it does have to keep up with calibration expiration as well as preventive maintenance at scheduled intervals. With these routine…   Read more»

It is important to have preventative action in medical devices because once a negative effect happens, it has already been out on the market if it was not prevented and this could cost lives. Reactive action is important but it…   Read more»

I have come across this issue with a certain gauge that was applicable to several parts of the production process. The manufacturing department argued that it can just be specified that this gauge has several locations but still performs the…   Read more»