I also work for a medical device company and I agree with the concerns above. I would also add a challenge that we face with design control quality is that they constantly make up new rules for us to ...

I just became aware of all of the complications surrounding Johnson and Johnson’s vaginal mesh so I did some more reading. Transvaginal mesh products are sometimes used during hernia surgery or to rep...

The FDA posted an article 3 days ago entitled “FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration” The FreeStyle Libre Flash Glucose Monitoring ...

Another combination product on the market is a catheter with antimicrobial coating. They are used to lower the risk of catheter colonization and infection. The Foley catheter, for example is describe ...

I have a friend that is currently transitioning from academic research to industry research. She said she is happier in her new role because she feels like she gets more feedback on her performance. H...

I haven't worked on any clinical trials or clinical research. But I came across this website that graphically describes the reasons for clinical trial failures from 2013 to 2015. It seems like "effica...

I read through many of the posts above and for the most part, everyone is interested in the immediate results. It makes perfect sense and I agree. People want to see the fruits of their labor. One of ...

In addition to competition against similar products, there is also a challenge of continuous improvement of the device itself. Medical Device companies almost always want smaller products with “cuttin...

I read an article online about effective project management for medical devices and I thought it was pretty interesting. The article suggests the use of matrix management as an ideal management style ...

I am currently working on a project that I inherited from a former coworker about a month ago. Very high level, it is a software driven update to some manufacturing equipment. It seems like the people...

Hey everyone, One of the learning objectives for this week was to get an idea of the different jobs available to Biomedical Engineers. In this week’s lecture, Dr. Simon identified a few positions that...

I don’t know if you can remove the undergrad stress over academics because you need that GPA for scholarships, internships and to make yourself more competitive as an applicant. I agree that you shoul...

I currently work in the industry as a manufacturing engineer and I am primarily focused on Design Control. Before starting this job, I had very little understanding of the industry. When I first start...