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 components that could malfunction, I believe that…   Read more»

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 it to function, which may cause…   Read more»

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 patients if businesses attempted to eliminate every potential…   Read more»

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 conventional foam liners with a multi-layer lattice that…   Read more»

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 think of them as more paperwork rather than anything…   Read more»

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, and standard operating procedures. In order to show that the procedure…   Read more»

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 you could decide that all…   Read more»

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 market. It’s quite difficult to determine…   Read more»

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 ignoring unsuccessful verification processes. Doing something…   Read more»

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 may improve your health, at least mentally. It can…   Read more»

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 accuracy of…   Read more»

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 the results when neither…   Read more»

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 frequently used by tech companies such…   Read more»

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 marketing and sales may be thrilling once…   Read more»

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 have listened to the most resulting in millions of…   Read more»

I believe it would be very useful to add an additional business subject to take. The majority of us graduate with knowledge of how to design or construct things, but not necessarily how a business operates or generates revenue. Having…   Read more»

I believe an MBA is not required for an engineer to launch a profitable company. Experience and problem-solving are the main factors that determine success in my opinion, even though business education can provide useful management and financial abilities. The…   Read more»

Depending on the organization, I would definitely decline a job offer if I had the option to choose. The research I would do on the company would not be extensive, but there would be some. Compared to a sole proprietorship…   Read more»

From what I understand, the FDA usually distinguishes between major and minor nonconformances. A couple of small errors in labeling or paperwork that don’t directly impact the safety or effectiveness of the device would likely be documented as observations in…   Read more»

I think a physician who wants to create their own medical device would face a lot of challenges, even though their medical expertise would give them a strong starting point. One major obstacle is the gap between knowing what patients…   Read more»