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vbp098
@vbp098
Eminent Member
Joined: Sep 1, 2025
Last seen: Nov 16, 2025
Topics: 0 / Replies: 33
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RE: Can Risk Really Be Eliminated — or Only Managed?

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 th...

10 months ago
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RE: Risk Management in the Manufacturing Process

I agree that avoidance is best solution, but sometimes depending on the situation, the best solution is more likely to simply mitigate the risk becaus...

10 months ago
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RE: When Mitigation Becomes Its Own Risk!

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 efficie...

10 months ago
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RE: Design Matrix Content

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 ...

10 months ago
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RE: Verification vs. Validation — Do We Really Need Both?

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 m...

10 months ago
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RE: When Design Controls Fail — The DePuy Hip Recall

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...

10 months ago
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RE: Do Design Controls Help Innovation or Slow It Down?

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 cr...

11 months ago
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RE: How Many Design Reviews Are Enough?

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...

11 months ago
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RE: Bridging the Gap Between Users Needs and Design Inputs

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 f...

11 months ago
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RE: Benefits for Patients in Clinical Research

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 ...

11 months ago
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RE: Handling Adverse Events in Trials

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 ha...

11 months ago
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RE: Placebo Effect

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 ...

11 months ago
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RE: Who Are You Selling To?

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...

11 months ago
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RE: Marketing Strategies to Differentiate from the Competition

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 ha...

11 months ago
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RE: Science and Strategy… or Just Storytelling?

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 s...

11 months ago
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