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pv223 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
Back on September 9, 2018 the FDA recalled a lot of Montelukast Sodium 10 mg tablets, the generic for Singulair 10mg. The reason behind this recall was a product/label mix-up which may result in some tablets of Losartan Potassium, or Cozaar, to be mixed into the bunch. This is a huge issue because Losartan is a medication that is used to treat…[Read more]
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pv223 replied to the topic RECALLS in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
I feel that when the FDA orders a recall on products or medications, it is not because the product itself is bad but a recent batch that was rolled out that may have some sort of defect that could cause harm to people. For example, Levothyroxine is a generic medication for Synthroid, which is a thyroid medication. While the medication itself has…[Read more]
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pv223 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
Working in the pharmaceutical industry, I do not feel that FDA regulations are too strict. When it comes to products that have a direct impact on our life, whether it be through food or drugs, this administration needs to make sure that whatever it approves is completely safe for humans. Sure, sometimes that philosophy may keep some products away…[Read more]
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pv223 replied to the topic This vs That in the forum Pre-clinical Device Development 6 years, 6 months ago
As you said, there are pros and cons to both kinds of research.
For academia, the work you do and the hours you spend researching has chances of completely changing the world, depending on the subject of the research. However, there is no guarantee that all those hours spent mean the research and project will be a success. There is a significant…[Read more]
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pv223 replied to the topic Research for the Fututre or Now? in the forum Pre-clinical Device Development 6 years, 6 months ago
While both industry research and academia research are important and necessary, I want my work to have an immediate impact, just like many of those who posted above. When it comes to academia research, there is always the risk that whatever you were researching becomes irrelevant if the hypothesis is proved wrong. With industry, the immediate…[Read more]
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pv223 replied to the topic Animals Used in Animal Testing in the forum Pre-clinical Device Development 6 years, 6 months ago
As nice as it would be to not have to run tests and clinical trials on animals, with the current technology we have there is no other reliable method of testing different kinds of treatments or products to see if they are harmful to humans. Instead, as Karen said, we have a system in place to minimize the suffering different animal subjects go…[Read more]
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pv223 replied to the topic Multiple Project Managers for one project in the forum Intro to Project Management 6 years, 6 months ago
Having multiple project managers that work on different parts of project management would not be a bad idea under two conditions: 1. The project is a huge undertaking where there is too much for one manager to manage and 2. They have their own manager or supervisor to report to. I believe the second condition is necessary because without it, their…[Read more]
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pv223 replied to the topic Manager Vs Engineering in the forum Intro to Project Management 6 years, 6 months ago
Like many who have posted above me, I believe that there should be a more transparent relationship between managers and engineers in order for communication to be more clear and fluid. I also agree that a manager should have experience that is related to the project in order for there to be a good structure and a more successful outcome. This way…[Read more]
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pv223 replied to the topic Project Objectives in the forum Intro to Project Management 6 years, 6 months ago
Just like krp67 mentioned, I believe the most important part of a project is for it to be achievable. If the end goal of a project is not achievable, then working on the project itself is a waste of time. Other aspects of a project are not even relevant if the project is not achievable to begin with. For example, if a project is not achievable it…[Read more]
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pv223 replied to the topic Thoughts on BS, MS, and PhD in BME in the forum Introduction to Medical Device Development 6 years, 7 months ago
In today’s world and with the way we are advancing, having a BS isn’t “good enough” anymore so to speak. In order to be successful and have a decent paying job it’s almost as if having a MS or PhD is mandatory. As for how to go about it, one common piece of advice that I’ve heard is to work a few years in the industry and then come back for your…[Read more]
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pv223 replied to the topic Thoughts on BME degree, "a little of everything" in the forum Introduction to Medical Device Development 6 years, 7 months ago
The thing with being a BME where we’re a jack of all trades but a master of none is that there is always going to be someone better in every area than us, simply because the major they went with was more focused in that area. While it’s nice being versatile and having some sort of prior experience on whatever it is we end up doing, there is a…[Read more]
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pv223 replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 6 years, 7 months ago
While having a more even split between practical and informational courses sounds amazing, with the amount of information we as BME students have to learn, it would not work without some reform to the curriculum. For example, we take half of hour undergraduate careers doing introductory courses and decide which track we want to follow. If the…[Read more]