vbp098

Forum Replies Created

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 that no one expected, so even if a product can start...

In forum Risk Analysis for Medical Devices

6 months ago
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 because otherwise the product will not be built. It is f...

In forum Risk Analysis for Medical Devices

6 months ago
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 efficiency of building the product after the update has b...

In forum Risk Analysis for Medical Devices

6 months ago
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 actual product on a mass scale. It should explain ...

In forum Introduction to Design Controls

6 months ago
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 meet deadlines to just miss a major flaw, so I pers...

In forum Introduction to Design Controls

6 months ago
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 and even if you have the best scientists availabl...

In forum Introduction to Design Controls

6 months ago
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 creatively in case their idea gets rejected initiall...

In forum Introduction to Design Controls

7 months ago
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 just one meeting, so it is necessary to have mult...

In forum Introduction to Design Controls

7 months ago
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 for too much. Because of that there is a need for a...

In forum Introduction to Design Controls

7 months ago
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 in the medication, but the risks of it being harmf...

In forum Clinical Research Basics

7 months ago
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 harder to find a method that can work for everyone. ...

In forum Clinical Research Basics

7 months ago
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 of the medication. If the placebo group were to do...

In forum Clinical Research Basics

7 months ago
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 spread the word because there are definitely conn...

In forum Marketing and Sales

7 months ago
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 harsh, but the products are going to be different in...

In forum Marketing and Sales

7 months ago
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 sell the product the most. Usually, the best bet is...

In forum Marketing and Sales

7 months ago
Page 1 / 3