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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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….   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…   Read more»

I would agree with bb254 in saying that I would also choose a limited liability company (LLC). There would be more flexibility in splitting profits, and also in splitting liabilities. If the company were to come into losses, they could…   Read more»

I agree with williamzembricki in stating that the largest issue with Document Control is the inconsistency. While Document Control exists to protect the entire company, there are some changes in the policy that come without warning or even without explanation….   Read more»

In my one experience with audits, the quality department must all be actively involved. The quality manager creates a detailed plan and assigns a designated role for each member in order to have a seamless system. There were no violations…   Read more»

I’ve experienced a similar set of circumstances in my work experience. I work in the production/manufacturing department. While quality and production are within the same physical environment, their work appears very separate. Even when working on related projects, one department…   Read more»

The FDA cannot foresee every possible outcome. There are usually a specific set of circumstances under which the device will be used, so if the device can pass certain quality and life-tests, it should not be an issue. However, it…   Read more»

Accuracy, as stated above, is an evaluation of the device to measure it up to existing standards. Precision evaluates the device against itself. Accuracy comes into play with the initial acceptance of the device. In order to accept the device,…   Read more»

AS Myton expressed in the previous post, Maquet/Datascope IABPs were recently recalled for the “False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump” [1]. However, this recall only resulted in the recall of the pump mechanism…   Read more»

While both are equally valued in their own ways, I personally would rather feel the impact within my lifetime. This is not only to see it in action, but to ensure that the work is carried out the way I…   Read more»