I would prefer middle management because you are more directly involved in the projects that happen. You have a better idea of what needs to be done and how to achieve them. Although it may be a lot of work,…   Read more»

Matrix organizational structures are more flexible in that you might have more flexibility with how you spend your time. With this structure, resources could be limited and there could be conflict if another project comes along and you have to…   Read more»

It always works out well when you really get along with the people in your groups. However, there does need to be some ground rules set before you begin working with someone you already know. Part of working in a…   Read more»

Once the meeting is set up and the purpose and function of the device is fully understood, it would be a good idea to have a group discussion about the potential risks associated with that product. Once the basic ones…   Read more»

I think one reason why companies get risk analysis wrong is because they know it requires a lot of work. What I mean by this is that once risks are identified and a plan is put out to deal with…   Read more»

One technique for risk analysis that I came across is a bottom-up approach called HAZOP (Hazard and operability). This is usually used for more complex devices that has a very involved process. In this instance, multiple control factors are identified…   Read more»

Design inputs include customer needs as well as customer requirements. These are the aspects of the product that are expected to happen. For example, if you state that your product has a sensor that should flash red when interacting with…   Read more»

It hasn’t happened to me personally, but recording the minutes of each meeting allows everyone involved to be on the same page about what was discussed. Many times some things may be stated or decided that are later disagreed upon….   Read more»

The purpose of Design Controls is to prove to the FDA that the product has all of the necessary requirements for being released to the market. The FDA needs a way of mapping out exactly how your product was made…   Read more»

Each document serves a different purpose. The DID gives a broader view of the product, outlining certain indicators and/or how it will function in a general sense. This document is mainly targeted towards people who are just trying to understand…   Read more»

If there is no way of mapping out how the device was made, the effects can be very detrimental. If something were to go wrong, there needs to be way of tracing back and figuring how/what went wrong and if…   Read more»

Design controls are a way to prove that you have done everything according to the procedures outlined by the FDA. It ensures that everything is accounted for in terms of risk management and that it performs the way it is…   Read more»

I think the point of a double blind study is that it eliminates any biases. The researchers and doctors might expect or wish for a certain outcome and might influence the distribution of the drug/therapy, making it biased. In order…   Read more»

Placebos used in studies are useful because they act as a sort of control. As stated previously, the brain is very powerful and can allow you think something is happening, when it actually may not be. As long as the…   Read more»

Clinical trials are necessary in order to further advance the final product. As Professor Simon stated in his lecture, you can’t assume that because something works in a mouse or rabbit, it will work the same way in a human….   Read more»

EI, or emotional intelligence, is the ability to understand one’s own emotions as well as the those of other people. EI is used a lot in marketing because it allows companies to focus on things that will grab peoples’ attention…   Read more»

I don’t know if I would use the word “manipulating,” but rather influential persuasion. People who work in marketing need to be able to persuade people enough to influence them to buy the product you’re trying to sell. A huge…   Read more»

To me, marketing is knowing your customers and targeting your sales pitch to get them to want to buy your product. This includes things like getting advertisements sent by mail or online, commercials/infomercials, or phone calls. Marketing in the medical…   Read more»

If a company of that size existed as an Inc corporation, it would allow more people to invest in the company’s shares. This also gives the option of eventually going public, which would create a lot of revenue for the…   Read more»

I think depending on your skill set, you need to decide whether the company’s success is big factor in accepting that position. If you’re fresh out of school, I wouldn’t think that this statistic would matter too much, unless however,…   Read more»