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 also be shared among owners. The taxes for an LLC are simple in comparison to most other corporations. However,…[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. This makes it very difficult for engineers or anyone else in the company to comply to…[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 that arose. There are of course minor delays in finding the exact documents to answer the auditor’s question.…[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 might be operating at a different speed than the other, with one…[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 is possible for a device to be used outside of the normal mode of usage, or if it was used for a patient it was not…[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, it should be confirmed that it complies with existing standards. The accuracy of the device qualifies how…[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 itself, the models CS100i, CS100, and CS300 [2] The intra-aortic balloon itself was not at…[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 want or to at least have control over the possible outcomes. By leaving research to simmer and marinate for generations, the next generation of…[Read more]

Depending on how urgent that research is, it can be done within the specified timeline or it may be put on the back burner for years. For example, in the company that I am a co-op at, I have found that research and development is not as high of a priority as manufacturing and production. This may be because the market is relatively stable and…[Read more]

While we are organisms of compassion, we are also organisms of advancement. With the need to advance, sometimes the compassion is cast aside in the name of science. In the case of live animal studies, it is sometimes necessary to closely imitate how medical research will fare in the human body. However, it does not completely justify the pain that…[Read more]

I have not worked in a situation with multiple project managers for a single project. However, I do see the value in such a dynamic. Having multiple project managers would ensure that there is no one person shouldering the burden of the entire project. With multiple aspects being managed by several individuals, the project could be more dynamic.…[Read more]

The challenge in manufacturing medical devices as opposed to a sky scraper or a bridge is the process of making it compatible with the body. These medical devices will be used in, on, or around the body and must be engineered as such. The involvement with the FDA makes this process all the more complex. The FDA has a very specific set of…[Read more]

In my experience, it is preferable for a manager to be someone who has come from a similar background or even better yet, has been in the shoes of the engineer. Specifically in manufacturing medical devices, a manager with only a business and leadership background will not entirely understand what an engineer’s concerns are for a project. This…[Read more]

As a student and a co-op in industry, I would tell fellow students to take advantage of all the resources we have at NJIT. Attend career fairs, go to networking events, and create strong contacts with your professors. The professors are all very knowledgeable in both research and industry. Career fairs also help build your confidence with speaking…[Read more]

While I have not had experience in academia, I prefer the workforce of industry. I see how industry has a direct influence on helping the general public, by creating a device that will increase someone’s quality of life and in some cases even save their life. While it takes intense research to get to that point, the end-goal for research and…[Read more]

In my personal experience, the theoretical courses are essential during undergraduate courses. These courses usually also have a lab component with hands-on learning. However, once students get to higher education it is essential to have a more balanced ratio. Having a 50/50 ratio of practical and informational courses would prepare students for…[Read more]