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vbp098 replied to the topic "Design Matrix Content" – 6 days, 7 hours ago
I think that these four columns are enough, but one more should be added it should be about the manufacturing process and how easy it is to build the actual product on a mass scale. It should explain the review… Read more»
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vbp098 replied to the topic "Verification vs. Validation — Do We Really Need Both?" – 6 days, 7 hours ago
I am a proponent for extra precautions being taken no matter how similar the steps may be because it is easy when as a company the goal is to simply meet deadlines to just miss a major flaw, so I… Read more»
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vbp098 replied to the topic "When Design Controls Fail — The DePuy Hip Recall" – 6 days, 7 hours ago
I think that unforeseen circumstances can always occur no matter how in-depth of a plan someone has, it is difficult to predict every possible outcome and even if you have the best scientists available it is easy to miss something…. Read more»
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vbp098 replied to the topic "Do Design Controls Help Innovation or Slow It Down?" – 1 week, 6 days ago
I do agree with the idea that these controls are slowing down innovation because it is preventing harm, but also maybe even causing people to think creatively in case their idea gets rejected initially. The idea of these measures is… Read more»
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vbp098 replied to the topic "How Many Design Reviews Are Enough?" – 1 week, 6 days ago
I definitely agree with what has been said about needing multiple reviews because there is usually some small aspect that can easily get overlooked at just one meeting, so it is necessary to have multiple reviews maybe it could be… Read more»
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vbp098 replied to the topic "Bridging the Gap Between Users Needs and Design Inputs" – 1 week, 6 days ago
From working at my coop, I realized that the customers usually have many wants and they are usually not all realistic because they are simply asking for too much. Because of that there is a need for a clear conversation… Read more»
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vbp098 replied to the topic "Benefits for Patients in Clinical Research" – 3 weeks, 1 day ago
I think they should be given payment because it is still a risk that they are choosing to take and there are of course possible benefits of partaking in the medication, but the risks of it being harmful are far… Read more»
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vbp098 replied to the topic "Handling Adverse Events in Trials" – 3 weeks, 1 day ago
I feel a standardized procedure may be hard to define as the research is quite different depending on the device that is being tested, so it can be harder to find a method that can work for everyone. However, I… Read more»
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vbp098 replied to the topic "Placebo Effect" – 3 weeks, 1 day ago
I agree with what has been said about negative results if the placebo effect seems to be helping patients because it seems to disprove the actual use of the medication. If the placebo group were to do better in comparison… Read more»
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vbp098 replied to the topic "Who Are You Selling To?" – 3 weeks, 6 days ago
I think the best mode of selling for this would be physicians and dentists themselves because they are the ones using it and they will be able to help spread the word because there are definitely connections. It helps if… Read more»
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vbp098 replied to the topic "Marketing Strategies to Differentiate from the Competition" – 3 weeks, 6 days ago
I think for a medical device it is best to highlight what the other brands are lacking and then exploiting that to sell your own product. It sounds harsh, but the products are going to be different in some way… Read more»
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vbp098 replied to the topic "Science and Strategy… or Just Storytelling?" – 3 weeks, 6 days ago
Building off what has been said already, I think it is important for people to understand their audience and then use a strategy that will help them sell the product the most. Usually, the best bet is to show off… Read more»
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vbp098 replied to the topic "Factors going into Buisness" – 1 month, 1 week ago
I have to agree with what a lot of people have said already about needing a business idea, but I think it is also important to figure out what kind of business you want to run. The plan for the… Read more»
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vbp098 replied to the topic "Sole Proprietorship or Partnership?" – 1 month, 1 week ago
I would prefer to create a Limited Liability Partnership or a Limited Liability Company because the liability protection is a lot better in these two in comparison to the sole proprietorship because as soon as there is an issue the… Read more»
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vbp098 replied to the topic "Public vs. Private" – 1 month, 1 week ago
I personally think that going private is the best for a company because it gives them a bit more freedom in how they want to run certain their business, which comes from the fact that there are less people that… Read more»
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vbp098 replied to the topic "organizational skills for QC" – 1 month, 2 weeks ago
I learned a lot about QC from my current COOP, essentially everything needs to be documented as soon as material arrives it is noted off, and its batch number is taken down. It is quite important in the medical field… Read more»
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vbp098 replied to the topic "Emerging technologies and QA" – 1 month, 2 weeks ago
I think that with technology that is arising as advancements are made it is necessary to keep up with them and try to find a way to integrate that into all parts of the world. QA/ QC would definitely benefit… Read more»
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vbp098 replied to the topic "Discussion Topic: The cost of Quality" – 1 month, 2 weeks ago
As frustrating as it is to be a QA/QC may be it is quite a necessary step because this ensures that people are not hurt and the cost will definitely be much lower in comparison to if the company were… Read more»
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vbp098 replied to the topic "Product Labeling" – 1 month, 3 weeks ago
I think if there is an issue with the packaging and the customer chooses to buy and use the product; it is on the customer because on the packaging it says not to use the product if there is any… Read more»
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vbp098 replied to the topic "FDA rules too strict?" – 1 month, 3 weeks ago
I do not think that a middle ground is possible because there will always be people that argue for either time range and say that it is too much or too little. It also depends on the product that is… Read more»
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