Currently, I work for a medical device company within the north jersey area. From my experience so far with the company, I would argue that is a functional organization. With such a large company it i...

I agree with the sentiments above in regards to picking project teams. Overall it is important to take a look not only at the team from a technical standpoint but from an interpersonal standpoint as w...

Risk management, from my understanding, is the act of ensuring your device is free from unacceptable harm. I believe the first step in any risk management plan is to determine your potential sources o...

For the case of the syringe, it would depend on the interaction with the body. I think that would have rather large implications and would dictate the various routes that may have to be pursued. For t...

I agree with the sentiments stated above as well. Overall you want to put a product out in the market that will in no way harm the patient and that can only be down through clinical or animal testing....

In my current position, I work within a functional organization. From the lectures I can understand how the disadvantages come about however I have no run into an issue of having silos form between di...

In response to ak977, I do believe that those are valid concerns to have over privacy. What I would propose as a potential solution is to have the transmitted data password protected, where the indivi...

I would argue that this product is a combination product. Abilify was first approved in 2002 and approved for use to treat Schizophrenia however the new novel aspect of this design is the sensor techn...

I work on the Merger’s and Acquisitions team for my company and our main projects when it comes to purchasing an outside company is to integrate and remediate the company to our standards. Generally w...

Replying to Amin's post on the intended use of Medical devices. I believe the company developing the device should do their due diligence in determining potential adverse effects of how their device i...

I think an important factor that should be taken into account is the consumer need and patient market when determining the priority for the projects. A project that does not receive the funding most l...

Project Management deals with different complexities within different industries. Say for example, within the medical device industry, there are different federal regulations such as the FDA or even I...