I believe from the point of view of a project manager, it can be the most challenging to work in a matrix organization. This comes from the conflict of everyone having at least two distinctly separate bosses. The project manager would have to coordinate with the staff to not interfere with their departmental obligations. This comes in contrast…[Read more]

I currently work in a functional organization, which to my understanding is the most traditional form of business organization. There are functional managers of each department, such as Manufacturing, Quality, Purchasing, and R&D. Within these, there are individual staff members who are recruited for the current projects being completed. I would…[Read more]

When forming a project team, it is important to consider someone’s skill as well as their personable skills. It is important to get along well with everyone on the team. It is not always ideal to choose close friends as there are personal limitations that would compromise the quality of the project. Sometimes when teams are picked by good personal…[Read more]

I think in the context of any other field, As Far As Possible is daunting and almost unattainable. However, in medical devices and anything else regulated by the FDA, it is necessary. The goal of the FDA is to have products that are safe and effective. It is sensible that companies should not even consider economics when reducing or even…[Read more]

It seems like a fair trade-off, especially for more established companies that know what their goals and needs are. However, for new companies like start ups, it would make sense to have some way to rent the material before purchasing it to see how it would align with their needs. Overall, it is important to have this documentation in order to to…[Read more]

Our company uses FMEA, which only differs from the acronym for FMECA by the one word “criticality”. In an FMEA, the Failure Mode Effects Analysis addresses potential risks of the product, whether in production or distribution. There is an extensive amount of documentation that covers every part of the production process that may carry risks, and…[Read more]

The ultimate goal of the FDA is to ensure that products are safe and effective. These are the two most crucial factors of a medical device. For design control systems, the FDA is making sure that every phase in the process is contributing to some way for the device to be both safe and effective. The FDA is also looking for a system that is easily…[Read more]

I am currently in Capstone I, and we have completed the phase of customer needs and business requirements. This phase is very similar to the process in industry, as we are learning in the course. Through gathering customer needs, we could identify what a customer would need when developing the product. These needs are specific yet contain no…[Read more]

I support @bb254‘s description of the process of design review meetings. While I am not yet an engineer, as a co-op I am often tasked with preparing the data and materials before an engineer’s design review meeting. For example I was responsible for testing samples for a protocol that they would be presenting for the design review meeting. The…[Read more]

As mentioned above, design review meetings happen at various points during a project, usually towards the end. In my experience in production engineering, however, design review meetings are conducted once a week and attended to by every engineer and upper level managers. These meetings are to establish the current status of smaller projects and…[Read more]

Currently in capstone this semester, I see the importance of the business requirements. We have yet to create test plans for our device. Through the detailed business requirements, someone not familiar with your product should have the ability to recreate it to some extent. All of the details must be quantitative if possible, and qualitative where…[Read more]

In my experience with minutes, it is important to keep them handy and organized, especially in anything involving a group and a long term project. For our capstone group, our advisor encourages or even requires us to take copious meeting minutes. This is important for the success of the project, so that everyone is on the same page when it comes…[Read more]

Every individual has the right to his or her own body, along with whatever may come from a study of it. In the case of Henrietta Lacks, she should have of course been given the right to refuse, as well as the right to fully consent, to the use of her cells in the name of science. If she had deferred decision-making rights to her family, they also…[Read more]

A double-blind study is necessary in cases where the investigator may become biased if they had knowledge of which is the effective drug. For the example presented in the question, with a drug to treat Alzheimer’s the investigator may selectively distribute the drug. In the unlikely case that they personally know someone in the study, they may…[Read more]

Placebo-controlled trials are necessary to the effectiveness of certain studies. In order to be sure that the drug or device is the factor that is in actuality changing the condition of the patient or just a change of mentality. There are cases where the placebo effect is so powerful that a patient will feel healed or treated, and the use of the…[Read more]

A product that does well without the use of television or other mainstream forms of advertisement is Krispy Kreme doughnuts. These have such a strong following of enthusiasts that search specifically for the coveted glazed doughnut that it does not require advertising. Additionally, other consumers will advertise simply by word of mouth or by…[Read more]

A vision statement, as discussed in the lecture, states the goal of the company, along with what they value and why they do what they do. A mission statement states how the company carries out these goals and what the company considers to be success. These are both essential in defining a company and setting it apart from competitors or to…[Read more]

In highly populated places like New York City, it is becoming popular to have interactive and immersive advertising tools. These can be in the form of exhibits or distributing samples of the product, or making it an “instagrammable” ad. For example, Perrier had a pop-up exhibit in NYC that enticed consumers to interact with the product. There was…[Read more]

Unfortunately, in a sole proprietorship, the company cannot be passed down. It would simply have to be the same company name but a different company. The sons of the owner would not have any rights to the original company created. The owner can hire his sons but once he dies he cannot pass down the money earned. As stated by gingeranderson, the…[Read more]

A public company has stocks that are traded publicly, so there are many people that own a stake in the company. Their financial statements are reported quarterly. Additionally, they are held to the legal standards of laws like Sarbanes-Oxley. An example of a very successful public company is Amazon with a revenue of $136 billion. Private companies…[Read more]