first of all Dr. Simon is right, never sign an indefinite NDA. Always make sure there is a way for the NDA to end. This applies to any contract you sing, make sure there is a way for it to…   Read more»

An NDA is most certainly not a patent. An NDA is basically two parties agreeing that they will not tell anyone about the information in questions. It is more akin to a trade secret than a patent. A patent is…   Read more»

I think that I am better suited for upper management. I have held high level leadership roles before, and whilst they were not in a company, they still suited my personality and how I like to work quite well. Being…   Read more»

I currently work in a matrix style organization. I think it fits me the best, and if I founded a company that is the way I would run it. The biggest benefit in my eyes is the ease of access…   Read more»

Organizational structure and workplace culture are definitely correlated. If a company wants to use a matrix structure it is important that there be a relaxed environment where everyone feels they can express their ideas freely and without consequence. If a…   Read more»

My research into Task Analysis and Use Error Analysis seems that it is a good way to attempt to mitigate risk that stems from the actual handling and use of the products. IT involves breaking down the function into as…   Read more»

Risk management once the product is in the hands of the end user is as you say, the largest part of risk management. Either through the use case, timing, or general negligence. As Dr. Simon pointed out, a surgeon in…   Read more»

Sadly I think access to these regulations costs because they can. They know companies will need access and that they will be willing to pay as they will see it as a cost of doing business. Is it shady? Yes….   Read more»

I have encountered this on a small scale. For my capstone project we are using InfraRed LEDs to illuminate the eyes with IR light. When we designed the circuit that will power the LEDs we needed to make sure that…   Read more»

Design verification is an essential step in the medical device development process. It gives quantitative data on whether or not the prototype of the device is working to specification. This allows for the understanding of problems that do not arise…   Read more»

Design controls are in their simplest form a way to make sure that the product developed and released is going to meet the user needs and also be safe for the user. The process makes sure that those who are…   Read more»

Meeting minutes are important as they serve as a formal record of what was discussed. If a decision is made in a meeting then it needs to be recorded, to avoid confusion in the future. In my job I have…   Read more»

Having conducting a bit of research, the closest thing to design documents are definitely what is written in your lab notebook. The research that I did involved many custom built parts, so there were many sketches and notes on design…   Read more»

I have participated in 1 design review at my co-op, and whilst it occurred similarly to what others here have mentioned I think some more specifics would help people understand them a bit better. The one I was in was…   Read more»

The necessity of having a clinical background is highly dependent on the role you will have in the clinical trial. All of the roles will be made easier with some level of clinical experience, but they all can be conducted…   Read more»

Double blind studies are needed because it eliminates any bias that can arise in the course of testing. If you are conducting a clinical trial for a drug you obviously want it to succeed, and if you know which patients…   Read more»

As much as it feels like they should unethical, I believe placebo controlled trials are necessary, especially in the case of new drugs. They are needed to tell if the new drug is actually effective when compared to something the…   Read more»

The best advertisement that I can remember is Tide’s ad form the last Super Bowl. They did an excellent job in utilizing tropes from many other types of commercials then flipping at the last second the make it a Tide…   Read more»

Having spent some time working for a consumer products company I can definitely see the importance of coloring in terms of branding. It is important for a brand to establish “it’s color”. One of the brands that I have worked…   Read more»

The major difference between public and private companies is simply who they are beholden to. Public companies are controlled by the public who own the stock. Those who buy more stock have more say but at the end of the…   Read more»