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Karen Immanuel replied to the topic S-Corp vs C-Corp in the forum Business 101 7 years ago
S-Corp, as we learned, are only taxed once while C-Corp are taxed twice. Although, this seems like a drawback for companies whose main goal is to make profits, for the health and overall benefit, C-Corp is the best way to go. Most companies follow the C-corp brach because of the benefits and flexibility. C-corp’s major benefit that companies like…[Read more]
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Karen Immanuel replied to the topic Discussion Topic: The cost of Quality in the forum Quality Control and Quality Assurance 7 years ago
The quality policies usually come off as a burden because they are usually at every step of the medical device development evaluating and cutting things short and asking for steps to be redone until it passes it correctly. Quality just seems annoying to any innovation from the perspective of other departments, especially the R&D. But in the…[Read more]
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Karen Immanuel replied to the topic Quality Control and Quality Assurance + Ethics in the forum Quality Control and Quality Assurance 7 years ago
I currently intern as a quality engineer, and in my department I do see how values, morals, and ethics pay a huge role in driving us to produce better outcomes. For example, in my company, many people always express how the fact that our products are directly inserted into patients battling between life and death and are in most cases the last…[Read more]
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Karen Immanuel replied to the topic What are some ways Document Control can improve? in the forum Quality Control and Quality Assurance 7 years ago
If the concern is about delay of product launch due to strict documentation and doc. control, I think that other departments need to understand and fully familiarize with ‘Good Document Practices'(GDP). The quality department is very very picky about how and when things are documented and personally, I don’t think that should change. Quality is…[Read more]
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Karen Immanuel replied to the topic RECALLS in the forum Regulatory Basics for Medical Devices 7 years ago
Hey I had a similar curiosity as well. I don’t have an answer to your question but I wanted to share my curiosity as it falls along the same lines. The FDA regulates medical devices and drugs before they are sent to the market. Yet, about one third of medical devices and drugs have failed (recently) in patients or in the shelf. Where do you think…[Read more]
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Karen Immanuel replied to the topic The people we shall encounter in the field in the forum Regulatory Basics for Medical Devices 7 years ago
Personally, from my experiences in internships and class projects, I’ve always had a positive outcome with diversity in the team. When it comes to getting work done, different perspectives and ways of judgment are always helpful, though not everything is used, they are considered. One thing about diversity that slows me (personally) is accent. I…[Read more]
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Karen Immanuel replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years ago
Yes the FDA is too strict, but when it comes to regulating a devise that affects a human and their life, the FDA needs to be really strict. This causes them to be slow, really slow. But I don’t think that’s bad. It’s better to be slow and sure than to be fast and allow a chance of failure (which could potentially cause death). I understand the…[Read more]
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Karen Immanuel replied to the topic Approaches to Research in the forum Pre-clinical Device Development 7 years ago
As discussed in the lectures, research in academia is usually passion driven while research in industry is money driven. Now, which is better? It is up to each individual to decide. What motivates you to work harder? What drives you to push forward and ask questions? Is it something burning within you or is it some appreciation that’s around you?…[Read more]
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Karen Immanuel replied to the topic Discussion Topic: Beyond experimental design issues in the forum Pre-clinical Device Development 7 years ago
When one is at the pre-clinical step of their research project, there are many crucial and resource-driven factors that will come against the flawless plan laid out. In cases where the research facility is 1000 miles away, these factors seem even more risky. Time, money, people, modes of transportation, ordering animals, getting the right…[Read more]
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Karen Immanuel replied to the topic Animals Used in Animal Testing in the forum Pre-clinical Device Development 7 years ago
From my experience in research, my understanding is that different animals are used for different types or levels of testing. For example, the initial testing of a drug is usually to test its cytotoxicity and immunogenicity. These tests are usually done in rodents such as rats or mice because they are abundant, easy to get, and are small. If the…[Read more]
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Karen Immanuel replied to the topic Obstacles while working on a project in the forum Intro to Project Management 7 years ago
I was once working with a team on a project that aimed to create a communication or “chatting” app between a phone and a smartwatch. So one person can directly send a message to another person’s smartwatch. We thought this was possible but when we came to the stage of developing it, we figured out that the smartwatch is not able to function as an…[Read more]
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Karen Immanuel replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management 7 years ago
I think there is not much of a difference in how project management is structured and executed between the medical industry and any other industry. But one major difference or challenge for project management in the medical field is risk management. Although other industries have this as well, it’s usually a static evaluation but for medical…[Read more]
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Karen Immanuel replied to the topic Milestones Missed: Failure or Success? in the forum Intro to Project Management 7 years ago
As Dr. Simon said in an earlier lecture, the end result or product of your project is never exactly the same as what you planned it to be. One of the reason for that is/could be because of milestones missed. Now, the change in the project can be a good thing or a set back depending on how well one can compensate for the missed milestone. For…[Read more]
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Karen Immanuel replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 7 years ago
Courses offered by NJIT are mostly informative and knowledge based. Honestly, I don’t mind that it is not all skill based. I think it is fair to pay to receive knowledge, but I wouldn’t think it is worth it to pay to be working practically, in turn it makes sense to get paid for it. Therefore, getting into research, getting internships, etc are…[Read more]
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Karen Immanuel started the topic Thoughts on BS, MS, and PhD in BME in the forum Introduction to Medical Device Development 7 years ago
Hello all,
I was just curious as to what level of education is best before getting into industry.
My thoughts are that BS is good enough to employ you with basic skills and knowledge. Later, you can specialize once you get into industry. Downfall to that is that you have to get into industry through low-paying entry level jobs. In these cases,…[Read more]
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Karen Immanuel replied to the topic Advice for Biomedical Engineering Students in the forum Introduction to Medical Device Development 7 years ago
A majority of you suggested getting co-ops and internships. But in reality not all striving BME students are able to get them. For those cases, I suggest getting into research on campus, joining professional clubs, and just talking to your advisor about your interests. These are some ways I was able to land an internship and the bases behind this…[Read more]