Another factor to consider is the Duration of harmful events. For example, cancer therapies and surgeries often cause adverse symptoms in patients that can last for the entirety of their treatment and even sometimes after.  If the cancer was going…   Read more»

In medical devices specifically, I would think that the nature of how a device may fail and harm an individual and the extent of the harm would impact and contribute to the risk value. While the likelihood of failure/risk is…   Read more»

I think a balance of both individuals with whom you have a relationship and individuals who have the required skill-sets/knowledge base makes for a good project team. A team made entirely of your, “friends” might seem like a good idea,…   Read more»

In all honesty, I think that the traits of upper and middle management are quite similar (depending on how you look at them). Both are required to be able to communicate effectively, articulate plans and goals, monitor the progress and…   Read more»

From my limited experience, I think I would actually prefer working in a project-based organization. While a matrix-organization does allow for potentially more personal growth since I would be working with a larger variety of people, a project-based organization would…   Read more»

Having these documents is one thing, making sure that these documents aren’t falsified is another. I think, along with ensuring that these documents are present and complete, the FDA most likely also looks into how accurate these documents really are. …   Read more»

Personally, I think human factors validation should only be re-performed if the user interface has changed with whatever product update has been done. As said in your question, validation is often not required if it can be argued that the…   Read more»

Unlike in the US, design controls are not required in Europe to release a product. I personally prefer the American method of requiring a DHF and DMF, specifically when the DHF is treated as an unchanging document while the DMF…   Read more»

I write down almost everything discussed during meetings. Not all of the information is useful, but doing such both helps me remember the meeting better and provides a basis for writing my weekly plan. In all honesty, I would say…   Read more»

In all honesty, I think it depends on the nature of your research. If you are working with animals or humans then comparative documents would be IRB approval and approval from animal review boards.  If you view it from a…   Read more»

As stated in the question: verification is required to ensure that the product works and that it is safe for a patient to use.  An example of this would be bandaids. I think, when designing a bandaid, it would be…   Read more»

Generally, clinical research is planned and designed to be as low-risk as possible for patients. Any human testing requires IRB approval and oversight at multiple steps of development.  This is necessary since new medical products or drugs can be extremely…   Read more»

The interesting thing about Henriatta Lacks case is that it occurred prior to legislation that now exists to inform and protect patients. (As well as occurring before legislation regarding the ownership of tissues was created. Fun fact: If you consent…   Read more»

I think that a clinical background is necessary but that the extent of such should vary. While someone may be able to do work in this profession, having experience working with people and being comfortable in a clinical setting is…   Read more»

In all honesty, I think marketing relies heavily on manipulation. Marketing convinces buyers that they need a product and then gives them reasons as to why they should buy it. It plays into their emotions and needs and convinces them…   Read more»

Emotional intelligence is one’s ability to modify their emotions to a scenario (i.e knowing when to be empathetic, knowing how to respond to the emotions of another person and how to control your own in an appropriate manner)  I think…   Read more»

I don’t know if I would define it as, “Clever” but I’ve seen people advertise their products by using another product’s viral failure. A good example is competitive advertising between fast-food companies, where they will often bash one companies product…   Read more»

I think when you get into giant companies such as Microsoft the risks behind these, “bad years” and, “bad ratios” reduce. They are so large and continue to make large amounts of money that even a drop in such shouldn’t…   Read more»

I don’t think I would necessarily turn down a company based on its type. As you said in your question, you tend to look at financial history and success before applying to a position. Even if the company is small,…   Read more»

In all honesty, I do not know if I would ever enter into a partnership. At this point in my life, I have no interest in organizing that level of responsibility and communication. That being said, if I were to…   Read more»