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 able to survey the environment and make decisions based on that is something that I feel I can excel at. Making long term plans is…[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 to knowledge and information. I work in product development, but if I have a question about the packaging or manufacturing of the product then I can quickly go…[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 worker has two managers, that means they will have pressure on them form two places. So it…[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 many steps as possible and then identifying the risks at each step. This allows for the manufacturer to see exactly where risks…[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 the operating room is not going to take the time to read the instructions when they remove the device form it’s packaging. Where…[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. But it is something that companies have to deal with. It is one of the many things that can hamper the growth of biotech startups.

One…[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 once it is all put together that the power outputted by the LEDs will not harm the patient using the product. Once we built the circuit…[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 until the device is actually built. As you said, merzkrashed, doing it early allows for these…[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 using it are doing each step of the design of the product with the necessary amount of checks in place to ensure that the final product they…[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 weekly one on one meetings with my manager to discuss what I am currently working on as well as anything he needs me to do or any questions 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 iterations in my lab notebook. But it was very different as there was no one really reviewing them. They were…[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 to review a new pain relieving lotion. due to the way my department functions, it was not exactly the same as the way one functions…[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 without it. Principal investigators and investigators will benefit immensely form this as they will be in the test center…[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 are receiving what treatment then you will be more likely to see positive results in those patients. If we use your example of a…[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 investigators know has no real effect. The ethical question of course is it ethical to give someone a drug you know will…[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 Ad. The use of positive emotions will always be more successful to me than using negative emotions. Many commercials try to sell…[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 with that does this well is Aveeno. They use a palette of soft browns to beiges. This ties into their active naturals…[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 day it is the owners of the stock that can control the business and it is to them that the upper management reports. Private…[Read more]

If I was to start my own company I would most likely decide on an LLC. The most attractive part of it to me is the lowered levels of risk. If the company goes out of business then it will not ruin me financially. The big downside to this for me is that I would not be in control if someone with more money wanted to be in control. I know that I…[Read more]

To me type doesn’t matter. What I value is the how the company operates, its core values, and if they will value me as an employee. I’m currently working a J&J. I really like the company because it operates in a way that allows me to feel like I work for a good company. WE try to hold ourselves to a high standard and make sure that we are putting…[Read more]