Class,
Thanks for the great 2018 comments. I do take all your words into consideration.

This is an interesting time in medical devices, as you will soon find out in your jobs or in my future courses. A lot of updates for my course material are forthcoming, so stay alert. I have just accepted an additional adjunctship to teach this course at…[Read more]

Interestingly, as a brand new development which I have not had time to update for the course, Design Controls are now in fact required virtually everywhere in the world. The new EU Medical Device Regulation (MDR) specifically looks for a quality system that follows ISO 13485:2016. If you look at ISO 13485:2016 (which itself is still very new),…[Read more]

test Spiral Medical Development test post

Is a student 100% equipped to know what he or she should focus on during the course of study?

Regarding budget cuts, keep in mind that although we do not get our funding almost exclusively from grants when we work in industry, we do have budgets and funding to worry about. When a company funds a project, there are often times that the funding is not enough, and you will need to calculate your expenditures carefully. This is of course IF…[Read more]

Remember as we discussed in Medical Device Development, even if something goes through the 510K process in the US, it still undergoes design controls and has its own DHF. Wanted to clear that up before anyone got confused.

Yes, good catch on the joint implants. They are a higher class in the EU than the US. The impression in general is that EU classifications are somehow less strict or easier or lower, and that’s not actually true in modern times. As you can see with the joints, it’s often the reverse.

Another example: in the EU any device with a new biomaterial…[Read more]

The idea, in general, is that there are two basic kinds of regulatory systems:

A) Systems that document the current snapshot of the device’s design/manufacture/risk profile, etc.

B) Systems that document the whole history of the device’s design/manufacture/risk profile from development up through marketing

Both systems nowadays require…[Read more]

Keep in mind that pharma trials are very different from device trials, i.e. Phase I, II, II vs. no phases. The larger CRO’s can do both types, but there are smaller ones that specialize in one or the other.

Keep in mind here that Participation always involves a two-way communication, over whatever media. Product placement, exclusive content, etc. and ads are all “push media” because they are one-way.

One trend to be aware of on these forums is the asking of questions to the class and not giving your own answer or opinion on the matter. That is not something that takes thought or substantive construction of ideas. I do like the thought-provoking questions, but also want to see the thought that follows….from the people who reply AND the…[Read more]