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 baking”. You tell them some things (that are public knowledge) and something that says you do something different. However, you do not tell…[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 is not associated with a lot of risk, then it is fine to only use a verbal contract. For example, if someone backing out…[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 management, you are working with the project teams and concerned with the logistics of the projects. You see…[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 goal and then it becomes a slog fest for them. Secondly, a leader needs to be animated. The leader needs to…[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 needed to do their job and give it to other people. We set deadlines for that and at the next meeting we will move onto the next developmental…[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 decisions are guided by worst case scenario simulations. This metric tells you that, at worst case, a very…[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 has an associate frequency and severity. For high frequency risks, increasing the sample size does not seem to make as much logical…[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 through till contact with end user. Once all the possible hazards are known, then…[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 by everyone is crucial. We used to just email the minutes, or try to remember what was said and quickly write it down…[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 the tasks up as small as reasonably possible to ensure that team members have a clear idea of what they are…[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 of its citizens. The EU is notably less strict than the US, and requires less thorough documentation, validation, and testing. If you wanted to…[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 for defects in the product, I was looking to see if my experiment showed any variable dependence. In the…[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 if ever understand each other fully. If a product is not verified, the…[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, less people become liabilities. In single blind, the researchers are liabilities only. In double blind, the…[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 with the responsibilities of their job. With clinical trials, it is arguably more important because…[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, there includes a section about further research using data gathered from you. Really, that is the whole point of the…[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 to the show itself. Oftentimes, a company will pay the show producer to include their product in the show,…[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 from Optum shows more action, they are committed to shifting and changing…[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 more positively if you are calm, concise, and passionate. As a marketer, you are the face of the company. You…[Read more]