Blinded studies are those in which either the patient, doctor, or scientist is not aware which group is getting the actual drug vs. the placebo. There are single blind (patient is unaware), double bli...

Good Clinical Practices, as defined by the FDA on their website, are "laws and regulations that are intended to ensure the integrity of clinical data on which product approvals are based and to help p...

I am interested in triple blind studies because I believe this is the best method to get unbiased and accurate results from a study. A triple blind study is a version of blinded studies, in which the ...

I feel this is particularly important for salespeople working for larger healthcare companies that have a large variety of devices, for example Johnson and Johnson or Medtronic. If you are a salespers...

I feel this is particularly important for salespeople working for larger healthcare companies that have a large variety of devices, for example Johnson and Johnson or Medtronic. If you are a salespers...

I believe the main differentiation between marketing and sales is the depth of knowledge that is required regarding the medical device. Due to FDA regulations regarding advertising, the marketing depa...

While I agree with the above posts that having a defined and quality product makes the remaining P's easier to accomplish, I do believe that promotion has an important role as well. You could have an ...

I agree that a MBA is not required because the knowledge you should have before starting a business can be learned through other ways, such as online courses and videos. However, completing a MBA prog...

I found an LLP called Covington & Burling LLP that specialize in providing regulatory counsel to device and diagnostic companies ranging from start-ups to multi-billion dollar companies. They have...

I agree with @ag2357 that creating a medical device company as an S-corp is the better choice. The worst choice, in my opinion, would be choosing a partnership. This is primarily due to medical device...

The concept of the cost of quality is very important and applies to every company in the healthcare field. This concept is particularly important when maintaining quality requires a commitment of mone...

Prior to this lecture, I had visualized quality control as a process companies had to do to appease the FDA and get their products out on the market. I assumed that companies would cut corners during ...

It is understandable that the relationship between Quality and other departments can become strained, especially when it can appear that the Quality department is making the jobs of other departments ...

As mentioned above, both functions of the regulatory department are crucial and equally important to the operations of the company. Both functions control different stages of the product lifecycle, th...

This is a very good question. In my opinion, an important point to keep in mind is that while the FDA's purpose is to keep people safe from harmful products, there are products that can be sold withou...