Risk controls should be kept in their design when it effectively mitigates a risk. When a mitigation effort lowers the initial risk but introduces new issues that are even worse, such as more componen...

The project team and the risk management team shouldn't necessarily be the same individuals because this might lead to heavy bias and/or blind spots. When you build a device, of course you would want ...

Since there are no zero-risk medical devices, I believe the objective should always be to lower risk to a manageable level rather than strive for something that's zero-risk. Nothing would ever reach p...

My team and I created a 3D-printed lattice cushioning system for construction helmets in order to lower the risk of traumatic brain injury for our capstone project. The idea was to replace conventiona...

I believe that many businesses, particularly smaller ones that are under pressure to launch a product quickly, first view design controls as merely another regulatory box to check. It's simple to thin...

I think a good contract manufacturer should do more than just produce the parts they should also thoroughly record every stage of the process, including operator training, equipment qualifications, an...

I think that defining "success" in quantifiable terms is the first step to converting a qualitative user need into a quantitative design input. If a user requests that a device should be easy to clean...

Improper implementation of design control might lead to several issues later on. Problems with the device may not become apparent until the end of development or even after it has been put on the mark...

Although I haven't personally witnessed businesses doing this, as I believe a majority of people haven't, I am aware that certain employees may be tempted to cut corners in order to save time by ignor...

The placebo effect can definitely cause some difficulties in clinical studies. It really is amazing how, even if the medication isn't helping in itself, the mere belief that you're receiving treatment...

I think I would like to work on the data management team if I was a part of a clinical research trial. The analytical aspect of research has always piqued my interest when it comes to verifying the ac...

I see your point that double blind trials appear to be a waste of time, but i think they have a decent purpose as others have said. It helps ensure that no one's expectations unintentionally affect th...

I've seen that many businesses spend a lot of time and money for their color selections, especially in relation to the feelings they hope to manifest. For instance, white, silver, and blue hues are fr...

Personally, I would prefer to continue working as an engineer. I like the technical problem solving aspect of engineering at least more than I would trying to sell something to someone, even if market...

I have noticed the use of Spotify's "Wrapped" feature as one instance of clever marketing participation. For those unaware the concept is pretty straightforward. Users show the songs and artists they ...