Right to Try seems to be a good step in terms of validating the drugs that companies make, assuming that it continues to use the “compassionate use” case in order to decide who gets these drugs. For patients that have no other approved option to turn to, potentially life saving drugs could be given to patients even if all known options have been…[Read more]

I agree with the point made earlier that manipulation and persuasion have some relation to each other, though manipulation tends to have a worse reputation that persuasion. Perhaps the differentiating factor though is the degree to which the recipient is aware that they are changing their mind. With persuasion (more presentation of facts and…[Read more]

In terms of software, what I have noticed (and what I have seen on my own phone) is that the most common colors that have been used are blue, green, and red. It’s not very often you see other colors like brown or yellow. Oftentimes, I have seen these less commonly used colors when it is actually being used to depict something in real life (Ex. a…[Read more]

For myself, I find that the commercials I enjoy the most are the ones that tell a good story. I think that when the commercial makes one feel good inside, it leaves the watcher with a positive feeling about the company who made it, if not then at the very least some level of respect for the advertiser. This type of commercial usually isn’t…[Read more]

There are several differences between public companies and private ones. For one, as many mentioned, a public company is able to sell shares of the company to the public, while private companies cannot (however they can sell private shares to investors). Another one, which I found interesting, is that public companies must report their records to…[Read more]

I would likely take a partnership with someone only if our ideas and vision aligned completely. That alone is something hard to find. If you have a partner who is not as committed as you are, when things get rough, you won’t be able to rely on them, or they will not have the same drive that you do to push through. Someone earlier mentioned that…[Read more]

As many other people have echoed, I think in the beginning of one’s career, especially right out of college, the type of company is not neccessarily the foremost priority in one’s mind when choosing a job. Oftentimes reputation, company size, culture, and a myriad of other factors are what can often weigh in on the decision. On the other hand,…[Read more]

Having awareness of a risk does not necessarily guarantee that it will be averted. Going along with the analogy Dr. Simon mentioned, if getting the form is similar to getting a speeding ticket, drivers are aware that speeding will result in them getting a ticket or worse from a police officer if they get caught. Being aware of the risk does not…[Read more]

If a company strives to just make the standards of regulations, then it would follow that the product would not be of the best quality. Quality standards within many medical device companies however tend to surpass the standards of regulatory bodies for a variety of reasons. There is a marketing point to not only meeting regulatory standards but…[Read more]

In response to the original post:
Document controls can seem stringent at times, however if they seem so, it is for good reason. At times, because of the controls, it can sometimes cause delays where there are different hoops that need to be jumped through in order to go from document to product in hand. However, having those hoops prevents some…[Read more]

Precision and accuracy are both fundamental aspects of medical devices to not only the FDA but those developing the device as well. In order for a product to be functional and successful, one aspect cannot be without the other. If a device is precise but not accurate, then it is not performing at the level that it should be. In other words, it is…[Read more]

On the reverse side, one drug banned in other countries but not the US is Soma (carisoprodol). It’s a muscle relaxant that treats pain and stiffness from muscle spasms. While it’s still prescribed in the US today, in Europe (especially in Norway) it is banned as it started to be used recreationally. The urgency in banning it was due to how…[Read more]

Sometimes there are circumstances that you could not possibly account for when you are designing a product or reviewing it from the FDA standpoint. While a company may design a product to function a certain way under a certain set of conditions, chances are that someone somewhere using the product will use it in a way that was not thought of or…[Read more]

In academia, one approach to research can often be starting a wide variety of projects that all interest you, seeing what has traction. Depending on what interests you the most or what is the most convenient (or needed) project, that project is the one that gets the most traction. It is all up to you as the researcher to define the timeline. In…[Read more]

While using animals in trials can often be a dicey object, where the line is drawn in terms of what animals can be used is not so often a hard set one. Like many other areas the answer tends to be “it depends”. What exactly is being tested? If it’s something that can easily be tested on a smaller “less significant” animal, then the line is drawn…[Read more]

An argument for working in academia is one that was told to me by one of my advisors: “Working in academia let’s you work on the cool stuff!” What she meant by this is that like Dr. Simon said, working in academia can often mean working on projects that are cutting edge, or things that no one has ever seen or even thought about. At that frontier,…[Read more]

Where I currently work, I actually have my direct manager, and his manager who also manages the entire team that I am on. Both of my managers have the approach of “whatever works for you” in that as long as you can get your work done in a way that is quality and on a reasonable timeline, then they are fine. They aren’t too particular about the…[Read more]

I think it might be easy to focus on any of these characteristics and say that any which one is the most important, but the way I see it, being achievable actually hinges on the other two mentioned characteristics in some way, shape or form. If an objective cannot be easily understood by others, then it simply cannot be achieved due to lack of…[Read more]

In response to Mattie718: Again though, to echo a point made earlier in this thread, it is not completely realistic to expect a manager to have done every single task prior that those under him have to do, at least at a high level. It may work on a lower level, such as a manager of a team within the same department. However, when teams become…[Read more]

The point jr377 makes is one that resonates with me greatly. Within my own time in undergraduate BME studies at NJIT, there come to mind 3-4 classes (within the biomechanics concentration specifically) that were just repeats of elementary physics or simple applications of concepts repeated constantly from class to class. There are only so many…[Read more]