Based on my experiences in the industry, the risk to quality isn’t because of incompetence or neglect. I believe it is mostly because of the pressures from project deadlines and teams not incorporating all relevant departments in project planning. For example, I was recently working on a design change project to help the software team deploy new c…[Read more]

I have not participated in an audit from an audit stand point but I recently attended a weeklong training on the FDA’s Quality System Regulation by AAMI University. The trainings were hosted by FDA, consultants, and at least half the class were FDA employees that were mandated to attend the course. It was a shared learning environment and the c…[Read more]

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 follow as per their ‘style’ of doing things or how they want it done. Sometime they mandate that things are done a certain way in the design change…[Read more]

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 repair pelvic organ prolapse or stress urinary incontinence. From what I havw read, the mesh has been risky from the start. The very first mesh in 1…[Read more]

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 System is a class III device by Abbott Diabetes so it would need an IDE and a PMA. It works by using a small sensor that goes under the skins sur…[Read more]

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 as “flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.” These type of devices are…[Read more]

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. Her job evaluates her performance frequently and it allows her to do better and grow in her new role. My friend also pointed out that in academic…[Read more]

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 “efficacy” is the most common cause of failure in Phase II and Phase III trials. There are more operational and commercial reasons for failure in Phase III…[Read more]

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 the reasons I chose to be a biomedical engineer was to “help people”. However, I do want to point out that long term research is crucial because the…[Read more]

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 “cutting edge technology” and that means increased complexity and increased sophistication of the design. If it is a long term design project such as new…[Read more]

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 who controlled this project before me did not consider potential impact to process validation and all of the processes that interface with the…[Read more]

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 shouldn’t sacrifice an opportunity for co-op, research, or an internship out of fear of your GPA dropping a little. But I do believe that exposure to dif…[Read more]

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 started, my coworkers and management tossed around words like validation, verification, design control, DMR, DHF all the time and I had to pick up on…[Read more]