Medical Device Courses | vbp098 | Activity

vbp098 replied to the topic "Can Risk Really Be Eliminated — or Only Managed?" -

Sun, 16 Nov 2025 14:37:53 -0500

Zero risk devices would be the dream goal, but that is impossible because as the lecture mentioned, someone will always find a way to create a risk that no one expected, so even if a product can start off being… Read more»

vbp098 replied to the topic "Risk Management in the Manufacturing Process" -

Sun, 16 Nov 2025 14:30:14 -0500

I agree that avoidance is best solution, but sometimes depending on the situation, the best solution is more likely to simply mitigate the risk because otherwise the product will not be built. It is fine line between balancing efficiency and… Read more»

vbp098 replied to the topic "When Mitigation Becomes Its Own Risk!" -

Sun, 16 Nov 2025 14:21:06 -0500

I think there should be two concepts that are taken into account when deciding if a change is actually worth implanting and it should be about efficiency of building the product after the update has been made and the severity… Read more»

vbp098 replied to the topic "Design Matrix Content" -

Sun, 09 Nov 2025 14:35:14 -0500

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»

vbp098 replied to the topic "Verification vs. Validation — Do We Really Need Both?" -

Sun, 09 Nov 2025 14:18:27 -0500

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»

vbp098 replied to the topic "When Design Controls Fail — The DePuy Hip Recall" -

Sun, 09 Nov 2025 14:07:10 -0500

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»

vbp098 replied to the topic "Do Design Controls Help Innovation or Slow It Down?" -

Sun, 02 Nov 2025 13:51:47 -0500

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»

vbp098 replied to the topic "How Many Design Reviews Are Enough?" -

Sun, 02 Nov 2025 13:40:54 -0500

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»

vbp098 replied to the topic "Bridging the Gap Between Users Needs and Design Inputs" -

Sun, 02 Nov 2025 13:22:56 -0500

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»

vbp098 replied to the topic "Benefits for Patients in Clinical Research" -

Fri, 24 Oct 2025 11:47:12 -0400

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»

vbp098 replied to the topic "Handling Adverse Events in Trials" -

Fri, 24 Oct 2025 11:27:35 -0400

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»

vbp098 replied to the topic "Placebo Effect" -

Fri, 24 Oct 2025 10:14:31 -0400

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»

vbp098 replied to the topic "Who Are You Selling To?" -

Sun, 19 Oct 2025 02:13:55 -0400

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»

vbp098 replied to the topic "Marketing Strategies to Differentiate from the Competition" -

Sun, 19 Oct 2025 02:07:27 -0400

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»

vbp098 replied to the topic "Science and Strategy… or Just Storytelling?" -

Sun, 19 Oct 2025 01:57:42 -0400

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»

vbp098 replied to the topic "Factors going into Buisness" -

Thu, 09 Oct 2025 00:24:09 -0400

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»

vbp098 replied to the topic "Sole Proprietorship or Partnership?" -

Wed, 08 Oct 2025 13:08:01 -0400

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»

vbp098 replied to the topic "Public vs. Private" -

Tue, 07 Oct 2025 22:24:43 -0400

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»

vbp098 replied to the topic "organizational skills for QC" -

Tue, 30 Sep 2025 04:15:47 -0400

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»

vbp098 replied to the topic "Emerging technologies and QA" -

Tue, 30 Sep 2025 03:59:30 -0400

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»

vbp098 replied to the topic "Discussion Topic: The cost of Quality" -

Tue, 30 Sep 2025 03:25:56 -0400

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»

vbp098 replied to the topic "Product Labeling" -

Tue, 23 Sep 2025 19:06:14 -0400

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»

vbp098 replied to the topic "FDA rules too strict?" -

Tue, 23 Sep 2025 18:43:37 -0400

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»

vbp098 replied to the topic "FDA vs EMA drug approval rate" -

Tue, 23 Sep 2025 18:32:28 -0400

I do not necessarily think that time is good gauge of whether the company is working well or not because it depends mainly on how many people are working on the projects. If the FDA has a lot more available… Read more»

vbp098 replied to the topic "Cutting Corners in Research" -

Wed, 17 Sep 2025 00:01:08 -0400

Cutting corners is mainly due to avoid getting fired, but sometimes the way someone cuts a corner is a better abnormal way of speeding up the process. It may not be normally used, but their strange method could actually work,… Read more»

vbp098 replied to the topic "Research for the Fututre or Now?" -

Tue, 16 Sep 2025 23:11:13 -0400

I think that it is hard to guess what long term research could lead to because you never know where your research is going to lead and what unknown discoveries, but it may lead to nothing. I agree that it… Read more»

vbp098 replied to the topic "Animals used for research and for food" -

Tue, 16 Sep 2025 22:34:32 -0400

I actually did not realize that the statistics was that startingly about the use of animals in research, but I think that people are starting to realize more of what goes on the background and want to change the cruelties…. Read more»

vbp098 replied to the topic "Project Planning: How Much Detail is Enough?" -

Sun, 14 Sep 2025 02:17:13 -0400

I do not think you can be over detailed in any way because this just ensures that you are covering your bases, but I think it also means sometimes that it can be hard to adjust because if you do… Read more»

vbp098 replied to the topic "Prioritizing tasks while managing multiple projects simultaneously" -

Sun, 14 Sep 2025 02:08:32 -0400

It has been studied that you cannot multi-task because your brain is not meant to work like that, so I would have to maybe say that the best course is to be organized as possible and ensure that the beginning… Read more»

vbp098 replied to the topic "Which feature is the most important for a project manager?" -

Sun, 14 Sep 2025 01:52:01 -0400

Personally, I would say the best feature would be to think creatively and being able to think on your feet because you have to adjust quickly when a problem arises, so I think if a person cannot do that then… Read more»

vbp098 replied to the topic "Is AI going to control the medical Industry ?" -

Sun, 07 Sep 2025 14:00:54 -0400

AI is becoming a very hot topic because it has the ability to work swiftly and efficiently, but it is lacking due to its errors which are based on the learning models that it is being presented. If for example,… Read more»

vbp098 replied to the topic "Academia or Industry Preference?" -

Sun, 07 Sep 2025 13:30:40 -0400

I personally did not enjoy working in research-based fields simply because it lacked a solid foundation. I always felt that if something went wrong it would be difficult to pivot and move forward, but I think it is a lot… Read more»

vbp098 replied to the topic "Co-Op / Internship Experience" -

Sun, 07 Sep 2025 13:18:16 -0400

I do not personally think that the idea of coop or internships is just making it easier for you in the future, but I think it mainly about what you can learn from it. I did not realize how much… Read more»