https://medicaldevicecourses.com/members/karen-immanuel/activity/ Activity feed for Karen Immanuel. Fri, 24 Apr 2026 19:23:05 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e1fc82f82a06af36e877b2a0d4a72d88 https://medicaldevicecourses.com/activity/p/17408/ Wed, 15 May 2019 21:39:13 -0400 This was such an awesome course! Taking this class parallel to my internship really helped. It helped me understand more about my company (and other medical device companies), its structure, and departmental functions, as a lot of topics covered, I…   Read more»

]]> ba7bda3e124eedd1985c2c872981617a https://medicaldevicecourses.com/activity/p/17404/ Wed, 15 May 2019 21:39:11 -0400 To be honest, I think these laws are necessary and I don’t really think they are too restricted. Yes it does make situations awkward (like when the doctor brings his wife and her meal can’t be payed for). But usually…   Read more»

]]> 3df9ae587fa2fddc8de727218bee0b20 https://medicaldevicecourses.com/activity/p/17402/ Wed, 15 May 2019 21:39:10 -0400 I think we need to first understand that both verbal and written agreements are recorded in some manner or the other. So both can be used and defended with. The difference is that verbal agreement usually isn’t as detailed as…   Read more»

]]> dbc465c72a495570fd5a98b661560c31 https://medicaldevicecourses.com/activity/p/17288/ Wed, 15 May 2019 21:38:15 -0400 Building a strong team is crucial to working better. I believe that a strong team is made of people with a mixture of skills. For example, they must have certain knowledge in their field, must be motivated to be on…   Read more»

]]> d923e9fd2a4fd9fa395f0323a442aaf7 https://medicaldevicecourses.com/activity/p/17286/ Wed, 15 May 2019 21:38:14 -0400 For collaboration process, I think matrix type organization is the best option. A matrix type organization allows people to move around based on projects and their talents. I think this is a good option because a project manager can pick…   Read more»

]]> fe8e7619a5940e34ba9ed26dd31e41cd https://medicaldevicecourses.com/activity/p/17258/ Wed, 15 May 2019 21:38:01 -0400 I work in a functional based organization. I work for a specific department and my manager is the department supervisor. I haven’t been a part of a project, but I work on tasks that is required within my department. If…   Read more»

]]> c72220cc223b8341f26a8fa1aae34b5d https://medicaldevicecourses.com/activity/p/17215/ Wed, 15 May 2019 21:37:36 -0400 When it comes to Off-The-Shelf (OTS) products, I think the quality department knows that consumers don’t really read the labels and instructions that warn them about risks, and try their best to make them as safe as possible. OTS products…   Read more»

]]> b756e16e7d2676061a767982331e9e25 https://medicaldevicecourses.com/activity/p/17210/ Wed, 15 May 2019 21:37:34 -0400 This is a great question! For high level risks, I would try my best to go with avoidance, I do not want to put the patient and the company at risk, given that we know the failure occurs frequently and…   Read more»

]]> 6179a838aa86c513eec02be581a4ae9e https://medicaldevicecourses.com/activity/p/17207/ Wed, 15 May 2019 21:37:32 -0400 Although severity and number of occurrence are the main large categories that must be looked at for risk management, there should be more evaluation and discussion of other categories such as user’s age, quality of life after product failure, cost…   Read more»

]]> d7bf519cfc9c34f8ed3d56a0139f1bd5 https://medicaldevicecourses.com/activity/p/17093/ Wed, 15 May 2019 21:36:35 -0400 In the company that I work for, we interchange the term “Design Control” and “Document Control” because everything in design control is detained in documents called Standard Operating Procedures (SOPs). So when design control fails, it means we have taken…   Read more»

]]> 5840e02908d053b73623f1aa6ea3d24a https://medicaldevicecourses.com/activity/p/17091/ Wed, 15 May 2019 21:36:34 -0400 As many of the students stated, design inputs so usually come from research and other investigational ideas. I would like to add that some also come from doctors and other medical companies. Hospitals and companies contract other companies to provide…   Read more»

]]> 81d4ae1ced82bd037ee090ed9fd9162b https://medicaldevicecourses.com/activity/p/16974/ Wed, 15 May 2019 21:35:35 -0400 I think the need or the advantage of the DID and DSD is that they serve two different audience. DID, which contains the broad specifications, is great for the customers, the ones who are actually interested in buying the product….   Read more»

]]> 53c0ffa6ff18a051210ce10311ca8ab3 https://medicaldevicecourses.com/activity/p/16973/ Wed, 15 May 2019 21:35:35 -0400 From my experience in research, we did also document a lot and were very specific. But we didn’t have anyone inspecting us or our documents, we did it for the sake of honest data that was needed for publication. When…   Read more»

]]> 1c079f0fde2e574c9fbd5d4977c4c0cf https://medicaldevicecourses.com/activity/p/16972/ Wed, 15 May 2019 21:35:34 -0400 When I used to work at a research lab on campus, I didn’t really pay much attention to the meeting minutes sent to me. This is because it had the information (tasks and decisions) for all the members in that…   Read more»

]]> a0f3a1c34eb0b9aefde554d45aa884b8 https://medicaldevicecourses.com/activity/p/16889/ Wed, 15 May 2019 21:34:51 -0400 Informed consent in very very important and I’m happy to say that now a days, it is taken very seriously. Back in Henrietta’s case, I don’t even think she was given a consent form, she just went for cancer treatment…   Read more»

]]> 5b3277fb9b95ed31931080f2820e26a9 https://medicaldevicecourses.com/activity/p/16887/ Wed, 15 May 2019 21:34:50 -0400 As many students above stated, having a clinical background depends on the role. There are some roles like the PI that require clinical background, this is because the role is usually critical and can’t allow much mistakes. Having clinical background…   Read more»

]]> 46f4f1bf1af85def594249361ec7e7d9 https://medicaldevicecourses.com/activity/p/16879/ Wed, 15 May 2019 21:34:46 -0400 Double blind studies much better than a single blind study, mainly to avoid mental bias. Thinking that drug will make someone better alters the mind to feel like it has actually worked. This is true for both the patient and…   Read more»

]]> c378cc57e43d6b1eab700ccdbbd611f6 https://medicaldevicecourses.com/activity/p/16797/ Wed, 15 May 2019 19:42:45 -0400 Emotional Intelligence (EI) is the ability to recognize one’s own emotions and feelings and of those around them. One will know if they have EI based on how they are able to cope with their own emotions and control their…   Read more»

]]> 7bd431a98967380354f9f76bbb47f08f https://medicaldevicecourses.com/activity/p/16793/ Wed, 15 May 2019 19:42:41 -0400 SWOT analysis for Becton Dickenson (BD) Strengths: – Strong Free Cash Flow – Highly successful at Go To Market strategies for its products. – Good Returns on Capital Expenditure – Highly skilled workforce through successful training and learning programs. -…   Read more»

]]> 29255c40c4a634af4a66a618b7c18708 https://medicaldevicecourses.com/activity/p/16791/ Wed, 15 May 2019 19:42:40 -0400 Marketing has changed over time. Gone are times when advertising was honest and to the point, now more tactics such as emotional intelligence and manipulation is used to lure people to buy the products. I think that the main reason…   Read more»

]]> aad2ee5fec6c012834b1d3c1c7a75d63 https://medicaldevicecourses.com/activity/p/16682/ Wed, 15 May 2019 19:41:35 -0400 If I was an entrepreneur, I would definitely do a partnership. Choosing the right person/persons is very very important. I prefer partnership over sole proprietorship mainly because it’s better to have more people to discuss, decide, and execute a plan…   Read more»

]]> f10e7908fdec34120c24897c1fe17ca0 https://medicaldevicecourses.com/activity/p/16681/ Wed, 15 May 2019 19:41:34 -0400 Being eager to get an internship, I really didn’t look into the company’s financial and economic history. But my dad was the one who sat with me and went through the company’s financial history, revenue, efficiency , stock price, competitors,…   Read more»

]]> ca0bcba830a3078d0bac876d5799ed78 https://medicaldevicecourses.com/activity/p/16680/ Wed, 15 May 2019 19:41:34 -0400 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…   Read more»

]]> 1c390247e0b4ec0d5cabe7367d4eb8da https://medicaldevicecourses.com/activity/p/16558/ Wed, 15 May 2019 19:40:19 -0400 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…   Read more»

]]> aa93272d32167b6b097450479e61714a https://medicaldevicecourses.com/activity/p/16556/ Wed, 15 May 2019 19:40:18 -0400 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…   Read more»

]]> 5a62af65c4a319c1aff1fe31caa3d6b3 https://medicaldevicecourses.com/activity/p/16554/ Wed, 15 May 2019 19:40:16 -0400 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…   Read more»

]]> 8a107b2d4e2079dafca47fbb98d768a0 https://medicaldevicecourses.com/activity/p/16459/ Wed, 15 May 2019 19:39:29 -0400 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…   Read more»

]]> 5bb15753c9e2023d30b288b4048829fd https://medicaldevicecourses.com/activity/p/16455/ Wed, 15 May 2019 19:39:27 -0400 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…   Read more»

]]> 56011c92d4c2c37ede7a43b458b6eea0 https://medicaldevicecourses.com/activity/p/16454/ Wed, 15 May 2019 19:39:26 -0400 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…   Read more»

]]> 29e4c483d2b7575c0e7e7f219fd571fe https://medicaldevicecourses.com/activity/p/16340/ Wed, 15 May 2019 19:38:19 -0400 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…   Read more»

]]> 59f79ba68384f11f3b67841fbd632a12 https://medicaldevicecourses.com/activity/p/16337/ Wed, 15 May 2019 19:38:17 -0400 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…   Read more»

]]> 239be4200c935ec57f805b8490fdfa95 https://medicaldevicecourses.com/activity/p/16336/ Wed, 15 May 2019 19:38:16 -0400 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…   Read more»

]]> a9319d76d3a2fb55dfd158e9da0c1f28 https://medicaldevicecourses.com/activity/p/16246/ Wed, 15 May 2019 19:37:24 -0400 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…   Read more»

]]> cff246d8af6b891500b609ec36866fdb https://medicaldevicecourses.com/activity/p/16244/ Wed, 15 May 2019 19:37:23 -0400 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…   Read more»

]]> a2c4139e24d133449e8268884d06e3d0 https://medicaldevicecourses.com/activity/p/16241/ Wed, 15 May 2019 19:37:21 -0400 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….   Read more»

]]> 295335dc944c3f4a7bb8fcd233c6b0cb https://medicaldevicecourses.com/activity/p/16143/ Wed, 15 May 2019 19:17:37 -0400 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…   Read more»

]]> 98d5f870fd8d4273b662fcf90c5cbcb5 https://medicaldevicecourses.com/activity/p/16141/ Wed, 15 May 2019 19:17:36 -0400 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…   Read more»

]]> 16e8691f601cad5f961984cb0637022f https://medicaldevicecourses.com/activity/p/10735/ Wed, 15 May 2019 16:36:04 -0400 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…   Read more»

]]> 3400f47a992b09b26a51918eb25902d7 https://medicaldevicecourses.com/activity/p/9248/ Mon, 03 Dec 2018 04:27:07 -0500 This was such an awesome course! Taking this class parallel to my internship really helped. It helped me understand more about my company (and other medical device companies), its structure, and departmental functions, as a lot of topics covered, I was able to experience first hand. I also love the way Dr. Simon explained each topic in detail, it…[Read more]

]]> 0 2b6783a41af263ee6c9ccefb7aa34006 https://medicaldevicecourses.com/activity/p/9243/ Mon, 03 Dec 2018 04:12:52 -0500 To be honest, I think these laws are necessary and I don’t really think they are too restricted. Yes it does make situations awkward (like when the doctor brings his wife and her meal can’t be payed for). But usually family members are not expected to be present during professional meetings and events, so it makes sense to me why such a…[Read more]

]]> 0 f7434ab1e227417360445e468b123366 https://medicaldevicecourses.com/activity/p/9239/ Mon, 03 Dec 2018 03:51:47 -0500 I think we need to first understand that both verbal and written agreements are recorded in some manner or the other. So both can be used and defended with. The difference is that verbal agreement usually isn’t as detailed as written agreements. But having a written agreement for everything is time consuming and can be a waste of resources when it…[Read more]

]]> 0 10ccc126c1009bf45ccf8a34271b042f https://medicaldevicecourses.com/activity/p/9117/ Mon, 26 Nov 2018 01:07:46 -0500 Building a strong team is crucial to working better. I believe that a strong team is made of people with a mixture of skills. For example, they must have certain knowledge in their field, must be motivated to be on board and to do the project, work well with others, and most importantly keep in communication! I think being comfortable in…[Read more]

]]> 0 050c97fe7214a47543d671324cfdb4d1 https://medicaldevicecourses.com/activity/p/9115/ Mon, 26 Nov 2018 00:56:45 -0500 For collaboration process, I think matrix type organization is the best option. A matrix type organization allows people to move around based on projects and their talents. I think this is a good option because a project manager can pick and choose the best employees of the company for each project. They can pick and choose who they think…[Read more]

]]> 0 18bde96289ba748e999e7139d07f751e https://medicaldevicecourses.com/activity/p/9086/ Sat, 24 Nov 2018 22:37:46 -0500 I work in a functional based organization. I work for a specific department and my manager is the department supervisor. I haven’t been a part of a project, but I work on tasks that is required within my department. If I had a choice I would like to work for a matrix type organization where I would be moved around based on projects. I like this…[Read more]

]]> 0 9559d3812265bb857e94e396bbcbb20a https://medicaldevicecourses.com/activity/p/9034/ Mon, 19 Nov 2018 04:45:49 -0500 When it comes to Off-The-Shelf (OTS) products, I think the quality department knows that consumers don’t really read the labels and instructions that warn them about risks, and try their best to make them as safe as possible. OTS products can’t be prescribed to a specific group of consumers, it can be used by young and old, readers and…[Read more]

]]> 0 ee2b3be259d40f78057a71d266c3c9fe https://medicaldevicecourses.com/activity/p/9029/ Mon, 19 Nov 2018 04:23:40 -0500 This is a great question! For high level risks, I would try my best to go with avoidance, I do not want to put the patient and the company at risk, given that we know the failure occurs frequently and its effects are severe. It’s not worth it to put a product out there, that could and most probably will fails and will affect the patient’s health,…[Read more]

]]> 0 07a4672aa9fe63b9949f6ea4d90bc9b4 https://medicaldevicecourses.com/activity/p/9026/ Mon, 19 Nov 2018 04:10:40 -0500 Although severity and number of occurrence are the main large categories that must be looked at for risk management, there should be more evaluation and discussion of other categories such as user’s age, quality of life after product failure, cost of replacement, cost of losing or damaging brand name, number of users, shares affected, patterning…[Read more]

]]> 0 7dbc920e04c771c26abf08e204d2fb84 https://medicaldevicecourses.com/activity/p/8906/ Mon, 12 Nov 2018 01:55:07 -0500 In the company that I work for, we interchange the term “Design Control” and “Document Control” because everything in design control is detained in documents called Standard Operating Procedures (SOPs). So when design control fails, it means we have taken a detour for the procedure. This introduces variability or failure in production. This could…[Read more]

]]> 0 7aef89612844da6138193a56b28b71dc https://medicaldevicecourses.com/activity/p/8904/ Mon, 12 Nov 2018 01:38:19 -0500 As many of the students stated, design inputs so usually come from research and other investigational ideas. I would like to add that some also come from doctors and other medical companies. Hospitals and companies contract other companies to provide certain parts and products. In these cases, they provide the design inputs to the contracted…[Read more]

]]> 0 084bc5f76976e862a25fc76ed3e9d1c0 https://medicaldevicecourses.com/activity/p/8783/ Sun, 04 Nov 2018 22:02:25 -0500 I think the need or the advantage of the DID and DSD is that they serve two different audience. DID, which contains the broad specifications, is great for the customers, the ones who are actually interested in buying the product. It is also good for project managers, to review the market needs and the importance of such a product. This audience…[Read more]

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