Perhaps in your career you will meet (or be) a physician who works in a hospital or private practice and wishes to create his or her own medical device. Though this is a noble goal, what challenges w...

Up until now we have talked about two big topics: project management and pre-clinical research. There are some other discussions in this forum about biomaterial selection for scientific and safety p...

I have mentioned that it is possible for a medical device to include drug and/or biologic aspects, which makes it a combination device. Think about what this would do to the rules and regulations tha...

Well said, JOnyekwere. Bioengineering deals a lot with the cultivation of biological products, such as those used in the pharmaceutical/biologics industries, and not so much the medical device field. ...

Take a look around the Internet and check out the various programs from different schools on Biomedical Engineering and Bioengineering. You can look at Bachelor's and/or Masters/PhD programs. What di...

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....

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 Reg...

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 fund...

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 befo...

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 ...

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 docum...

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...

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.