Dr Simon, I enjoyed this course pretty thoroughly. It is refreshingly different from most courses at NJIT in the sense that it gives information about how the world actually works, not how a concept works in an ideal situation. It…   Read more»

An NDA is a way of allowing you to tell some things, but not the whole story. It is analogous to if you told someone a family recipe for cookies. “A little flour, sugar, vanilla extract, a special blend, and…   Read more»

Verbal contracts are hard to defend in court and are thus not quite as actionable. Generally, if it is important and there are risks associated with one party backing out, it goes in a written contract. If breaking the contract…   Read more»

In upper management you have real control over the company but most of your work is confined to maintaining the company and dealing with finances legislature. You are in the position of maintaining the logistics of the company. In middle…   Read more»

From my experience the best impact of worker performance is leadership. This works both ways, poor leadership means very poor outcomes. A leader needs to firstly have a clearly defined vision. Without a vision the workers cannot see an end…   Read more»

The first thing our team did was go over the timeline of the project. We set up a simple flowchart of what has to happen and what everyone needs to do. Then, we started giving tasks to the people that…   Read more»

In the assessment of risks of devices section (4.2) the standard lists duration of the risk as a parameter. This is an important distinguisher because it dictates how much damage a risk can do under worst case scenario. Oftentimes business…   Read more»

The type of risk plays a role in what statistical analysis you need when testing. Most companies here just use a higher sample size when testing high risk hazards but I believe it can go deeper than that. Each risk…   Read more»

I believe the best results from a risk analysis meeting come from minimizing bias. The beginning of the meeting is about finding hazards by going through the chronological life cycle of the project. Starting with the machining/manufacturing process and following…   Read more»

I am president of a new start up club on campus and we have used various methods to keep track of the meeting progress. Having someone take notes throughout the meeting and upload them directly afterwards to a folder accessible…   Read more»

The Gantt chart is a useful organizational tool, if not for actually keeping track of the project timeline. When creating the Gantt chart, you are forced to think about reasonable time estimates for the project tasks. It helps to break…   Read more»

If you were to make a device in the EU, it would be subject not to the regulatory documents required in the US but to those required in the EU. Every country has its regulating body that ensures the safety…   Read more»

Statistical sampling tests I have used for research included the paired t-test and one way ANOVA. Typically, for something to be taken as statistically significant, a power of 95% or better is needed. Whereas in industry you will be checking…   Read more»

Verification ensures that the the customer specifications are meant. Without verifying specifications, you are blindly trusting what the manufacturing department took to be what was meant on the DID. In industry, this is a dangerous assumption because the departments rarely…   Read more»

Putting blinds on a study makes its results subject to less bias and outside influence. The more blinds there are the more representative of normal the data will become, and thus the more believable. With each addition of a blind,…   Read more»

Asking for clinical trial experience is just asking for job experience. If you apply for a systems engineering job, the company would want systems engineering experience. It is the same thing. Companies always want to hire people who are familiar…   Read more»

The necessity for informed consent in clinical trials is purely a legal issue. Before the days of informed consent, it was morally enough to ask “can I treat you”? The same morals still apply today. In many informed consent forms,…   Read more»

Some of the most interesting methods of subtle marketing I have seen are used in television. Everyone knows that no one pays attention to advertisements in between shows. However, everyone who is watching the show is going to pay attention…   Read more»

“Shifting Health Care Models By Putting People First” Optum “Developing Software to Help People Get Well, Help People Stay Well, and Help Future Generations Be Healthier” Epic I think Optum’s mission statement instills greater confidence than Epic’s. The mission statement…   Read more»

Emotional intelligence, as previously said, is the measure of someones ability to sense emotions in other people. But, it also measures how well the person knows their own emotions. In marketing, you need to keep a cool head. People react…   Read more»