I feel that it is acceptable to take the risk of a clinical trial when the results of the trial are expected to either benefit or not affect those involved. This would be in the case of testing an int...

Placebo-controlled studies are a necessity when it comes to establishing the efficacy of a drug, however, their ethical foundation comes into question when a placebo is given instead of an established...

I feel that, while not necessary, it is very advantageous to have a clinical background in the role of a CRA and especially in the role of a principal investigator. The reason for this is that a clini...

While the comparison between Apple and a medical device company is a bit of a stretch, they do use some similar techniques in terms of advertising. My father, who is a physician, always comes back fro...

Participation is an important aspect of marketing because of how easy it is to block out all the noise. Companies need to make it so that their consumers seek out and engage with the company and the p...

I feel that there is a strong negative connotation to the word "manipulation" and that its use in this field is not always appropriate. When the features of a product or the availability of a product...

I think this question depends heavily on the business being started. In my case, I have an interest in medicine and would probably open a clinic as an LLC. As an LLC, my company would be separate from...

Using data published by the Wall Street Journal on Tesla Inc. (TSLA) I have found the following metrics to be very interesting. Earnings per share: -4.68 Gross Margin: +22.48 Operating Margin: -9.86 R...

A company of that size would need to weigh the benefits and drawbacks of both of the choices. An LLC is excellent for smaller operations at it offers protection in the form of reduced personal liabili...

Quality control is similar to an insurance policy for a company's product. It is expensive, burdensome and, for younger companies, not obviously necessary. However, as the company grows, the need for ...

While I haven't been witness to any exceptional quality practices, I remember reading about how the auto industry handles mechanical defects in some of their parts. Apparently, if a defect is discover...

In my opinion, the best quality departments can work with both the company's and the customer's needs and wants in mind. In order to mesh well with the vision of the company, and allow for a synergist...

Although e-cigarettes are currently regulated by the FDA, they come with hazards that are overlooked because they are viewed as a "healthy" alternative to smoking. The combination device works by vapo...

The net effect of the increased user fees seems to be pointing to increased cost for small to mid-sized businesses in the medical device field and a greater burden on the end user of the device. Smal...

I agree with the points you made; the regulations of the FDA do, indeed, protect us and the compromise is worth the lives being saved. However, I feel that there is still room for improvement in the ...