Refreshing this topic for the new class coming in.  See the first post in the thread here.

What other changes are we seeing in the medical devices industry due to covid19?

A thought here to stimulate more discussion:  Different strokes for different folks.   There are people who like to go to work every day and do the same thing.  Maybe, as someone who is not like that, this is a weird…   Read more»

Posted by: @dh239 Practical courses do fall short to informational courses when research or academia is the goal of the student. For professionals and those looking to go into industry, practical courses are perhaps the most important. For that reason,…   Read more»

@quanzi What specifically do you mean when you say that a “metal for a stent would be incompatible for use with a breast plant”?

@quanzi Yes, and “difficulty” of a medical device project has a number of facets to it.  There’s financial difficulty, technological difficulty, clinical difficulty, and others.

@quanzi Yes, and “difficulty” of a medical device project has a number of facets to it.  There’s financial difficulty, technological difficulty, clinical difficulty, and others.

You definitely do not want to start a project before you know the idea is feasible, but let me ask this: in strict terms, couldn’t the feasibility practices be a project themselves?  Wouldn’t you want to manage feasibility like a…   Read more»

Face to face interactions can become too much at times, keep in mind.  Ever hear of a company, or work in one, that does nothing but have meetings which leaves nobody with enough time left over to actually do the…   Read more»

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…   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…   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…   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…   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…   Read more»