From the standpoint of a biomedical company, I don’t believe sending document for review ahead of time, would necessarily imply that your documents will be reviewed faster. Given the large number of projects that a company might have at a time, your document will mostly like be buried until its actually review date approaches. However, to expedite…[Read more]

I believe there are three fundamental criteria undeniably important when it comes to picking out project team member. Those criteria are communication, compatibility and expertise. I hold communication to be the highest in term of importance out of these three categories. It doesn’t matter how well informed and educated the member of the team…[Read more]

To better judge the qualification of the Left-Atrial Appendage Closure Device, we should first recognize that classification is based entirely on risks. The risk for any devices ( medical or not) becomes less prominent as the use of the device becomes more common. This statement implies that we tend to learn and know more about an instrument by…[Read more]

Have I read this post three years ago, my immediate answer would have been “no”. My recent experience in the military, special with combat medic forces, has colored my perception. In a standard setting, where medical ressources are not scarce, FDA regulations should be implemented regarding the use of medical devices. However, as many pointed…[Read more]

In terms of labeling mishaps, there are two criteria that should be considered: The adhesive property of the label to the product container as well as the content of the label itself. Reading the comments above, not much importance seems to be given to the adhesive property of the label. I believe that aspect of labeling is just as important as…[Read more]

Since ethics and regulations were not fully enforced back then, I don’t her family will be receipt any compensation. Some may argue that the regulation should be made to be retro-effective, but I wouldn’t agree with that. If all regulations were made retro-effective, a chaos will created. However, I do believe that the scientific world should at…[Read more]

Clinical research is a huge industry that encompasses many different professional roles – including medical writers, clinical trial managers, and biostatisticians.
Although having a clinical background is the preferred option when applying for CRA positions, I don’t think it is entirely necessary. With a strong background in science and the a…[Read more]

In a single-blind study or experiment, the subjects don’t know if they are the experimental test subjects or members of the control group. But the tester knows. In short, the subjects are not told their identities in the setup.
In the double-blind setup, both the tester and the subjects are blinded: both are not told of the subjects’ identities in…[Read more]

Placebo of clinical trials are ethically acceptable provided that patients receiving placebo are not at risk for serious harm and give informed consent

I have heard of a situation where participants of a pharmaceutical cancer trial got together in a room following a group informed consent session and combined their meds and then divided them out…[Read more]

I think when we use the term manipulation as it pertains to marketing, we already attaching a negative connotation on that term. Perhaps if we use the term “persuasion”, in relation to marketing, we wouldn’t be so quick to refer back on that negativity. Although some might argue that “persuasion” is a less obvious form of manipulation, I believe…[Read more]

To me, marketing in its simplest form is the act of getting into the market while doing something. Like Act is a play but when you start doing it, it is Acting. Work is there but when you start doing it, it is working. So basically for me, it is the act of getting into the market while performing an activity. Marketing is four P’s that involve…[Read more]

I remember a commercial for DOVE products that stood out to me. I have always used Dove cosmetics products for as long as I can remember and given that I have a peculiar interest in this women studies especially in woman self-hatred and lack of self-esteem, it just seems logical that that particular commercial piqued my interest. In the…[Read more]

From the list of grand strategies that Dr. Simon mentioned in his lecture, I will focus mainly on market growth. Market growth is a low-risk strategy compared to other, more encompassing, strategies. Instead of investing in research and development to create new product offerings, the market-growth strategy focuses on growing the market for a…[Read more]

I would consider partnership over sole proprietorships. In partnership, owners share loses and costs which can substantially beneficial if individual owners couldn’t afford them on their own. The company will benefit from the complementary skills of partners, however, there could also be potential disagreement among partners which, if severe,…[Read more]

An advantage of Cooperations lies in the fact the company’s debts can’t be transferred to individual owners. However, this advantage comes with the requirement that personal assets be separated from those of the company. For instance, using a company credit card to pay off personal expenses or the owner neglects to follow vital LLC rules and…[Read more]

As the name indicates, sole proprietorship implies that a company with the single owner which will dissolve if the owner dies. Passing the company on to the two sons will require to create a new company. As Dr. Simon suggested in the lecture, the sons might utilize the resources the father’s company, however, legally, the son’s company will be…[Read more]

I would prefer filing my company under a Limited Liability Company (LLC). First of all, an LLC limits personal liabilities because an LLC is legally separate from its owners. LLCs are responsible for their own debts and obligations, and although you can lose the money you have invested in the company, personal assets such as your home and bank…[Read more]

I used to ponder about the relationship between physician and drugs designer as well, so I completely understand where you are coming from. However, I believe eradicating or improve this relationship which is truly toxic to the patient will never fully be accomplished. It all boils down to the nature of humanity as a whole. We tend to make profits…[Read more]

From other departments point of view, I understand why they can sometimes regard Quality as a burden. Ultimate, Quality gets to determine if their project gets to move to the next phase or get complete rejected. Imagine spending time and energy in research and design to be finally rejected at the end. It might be the best feeling ever. however,…[Read more]