I think making changes in the design early would be the most efficient when completing a cost/benefit analysis. Changing the design early on is usually cheap because nothing has been manufactured yet,...

I think that risk acceptance does not really create a higher probability of risk, but it does mean the risk stays the same because nothing is being done to lower it. Usually companies only accept risk...

Some benefits of implementing a risk management assessment for a device include finding problems early before the device reaches patients, making the device safer. It also saves the company time and m...

I agree, a surgeon, nurse, and patient can all want different things from the same device. I think one way to make sure everyone is considered is to actually go into the hospital and see how the devic...

I agree, this was something we struggled with too. One way I think about it is that the user need can stay the same, like "easy to operate by surgeons," but you break it down into something you can ac...

The good thing about the DID is that it gives an overall description of the device and what the user needs. However, it is not descriptive in detail, so it would be hard to build or test the device fr...

To define success criteria, the team must have a plan and a step by step process. First they need to know what the device is supposed to do and the user needs. Then they set criteria that can actually...

I think that verification and validation are both equally important. It can be somewhat simultaneous depending on what the design or device is. However, if they are worked on simultaneously, it could ...

When it comes to design, user needs are the first step. If you do not know user needs, you cannot continue on to the next part. Knowing what the user needs is key to developing a successful design or ...

I think the responsibility depends on what went wrong. If the doctors and scientists followed the approved protocol, got proper informed consent, and the patient knew the risks, then it’s not really o...

I would not put anything out on the market until I have more information regarding the testing and the pill. If the pill was really a placebo, it shouldn’t have done better than the placebo group, so ...

This question is actually a good point. Clinical trials should be accurate, and the placebo effect can make that harder. If the placebo group shows the same results as the group getting the real drug,...

Using color for marketing is interesting because different colors represent different meanings. For example, the color green can represent health, wealth, and nature. Nature’s Bounty, a supplement and...

With the advancement of technology, the way companies market has tremendously changed. Instead of using media like TV or magazines, marketing now uses a lot of digital tools to attract customers. It i...

When it comes to sales, especially in the medical device industry, the main thing is building long lasting relationships. To be a successful sales rep, you must know your product as being in a clinica...