I think that it is certainly sometimes crucial to go back to the planning phase in order to ensure the success of a project. Regardless of how well a project is planned out, sometimes obstacles and se...

While it is important to manage risk, it is also important to encourage creativity and risk taking within a company. Risks are what lead to breakthroughs and great medical products that can advance th...

In addition to what ak977 said, the main mission of medical device companies is to improve healthcare. Cutting corners just to increase profit or prevent the company from losing money is unethical and...

I think an important thing to add to this discussion is how to adjust things when out of scope - whether it be due to budget or time. An example is in capstone, whenever something takes more time than...

I think that an additional topic to add to this discussion is while large corporations experience this issue with class II and class III devices, sometimes going the less creative or risky route with ...

Online reviews of this book explain how Lenzer compares and contrasts pharmaceuticals with medical devices. Lenzer makes the claim that pharmaceuticals go through more testing than medical devices. Do...

From reviews online, it says Lenzer has written about several devices that have been proven problematic. Investigative journalism can sometimes bring notice to problems that may be overlooked. For ex...

Through getting my bachelors degree at NJIT, I felt that my interpersonal skills have improved tremendously. Different experiences that improved my interpersonal skills included getting involved with ...

Of course emotional intelligence combined with technical knowledge are important qualities in a project manager, as well as all of the qualities people mentioned above. To me, one of the greatest sk...

Verification and validation are one of a project’s largest costs. Rework is the only cost larger than verification and validation in a project. If it is not adequately planned, not only will the sched...

I think that all of this definitely should, and hopefully is, going through medical device reporting to the FDA. In my opinion, spending money and time to re-test this device is not the responsibility...

In correction to my last post, fitbit does not currently monitor blood pressure. However, what I wrote about applies to the physiological factors it does monitor such as heart beat. On the other hand,...

In response to AnmolKaur, MDR is very important. If a medical device is resulting in deaths or injuries, it needs to be investigated and potentially taken off the market. After pre-clinical and clinic...

Class 1 devices are intended for devices that require general controls by the FDA. At home blood pressure monitors are considered a class 1 device. Although they are not intended to diagnose, people r...

As stated in Dr. Simon's lecture, leadership is 30% academic and intelligence based and 70% interpersonal skills based. While I do not have experience in industry, I spent this entire past fall interv...