What company would you choose to analyze, alexandrabuga?

We will learn later than an IDE is required for any clinical trial that poses significant risk, and usually this means that if you change the standard of care for a patient in the clinical trial, it is significant risk and thus needs an IDE. So, even if this device fell into Class II, it would need an IDE trial.

So given the content for this week, let’s think about this. Some of you are saying, and pointing out, that e-cigs are drug delivery devices rightfully regulated by the FDA. If this is a Class III device, it would mean that clinical trials are necessary for EVERY e-cig on the market. So, if I want to copy a competitor’s e-cig model, I still need…[Read more]

Right, so the underlying message there is that CRO’s are businesses that want to maximize their turnover. The more studies they do, the more money they make.

How is the situation different in a university? Obviously they also want to make money, but in this specific case of animal studies, that’s not the main motivating factor. What is?

Some great points made above, yes. You see some of the pitfalls that have happened with favoring close connections over sound business decisions, but as some of you correctly point out, the sound business decisions are not clear-cut either.

* University overhead can make an animal study nearly twice as expensive as doing it at a CRO
* Personal…[Read more]

That is an excellent point. What happens many times is the project is broken up into sections. There’s a general product development project, and then several separate regulatory projects hooked onto it, one for each country or region. You will often see a medical device come onto the market at different times in each country due to the…[Read more]

Definitely a good question, especially since either scenario could occur in real life: you could be working on a remote team, or working in an office every day. In either case, you would need to be able to do this kind of work.

I would like to thank everyone for the great feedback. It confirms for me that the reason why I made this course and the way in which I designed it are benefiting people. You were a good group.

One point I do want to make is that this course is definitely medical device based. Whatever useful information you may find here about the…[Read more]

That’s an interesting comment which got my attention because it is different from some of the others. What other names or verbiage in the description would make it more accurate? Tell me more.

Think about a medical device being used during a surgery. The surgeon is scrubbed in and working on the patient. The techs in the OR are following the surgeon’s instructions to hand things over, rinse things off, etc. At what point do you think anyone is going to open up the device out of a package and start reading the instructions or warning…[Read more]