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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...

6 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...

6 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...

6 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 ...

6 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...

6 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...

6 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...

6 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...

6 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...

6 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 ...

7 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...

7 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 ...

7 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...

7 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...

7 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...

7 months ago
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