There can be a lot of reasons to change a device and as long as it doesn’t effect he safety, efficacy or performance of the device, there shouldn’t be too much of a hassle to change it. Reasons to change…   Read more»

At work we were working on a project to develop a new diagnostic test. We hit a road bump about 2 weeks prior to turning over the project to manufacturing. This put the entire project behind by a week. Fortunately,…   Read more»

I recently have found it interesting at my job how different the metrics can be based on what upper management deems a quality project or not. It’s pretty self explanatory but I’m working on two projects and one of them…   Read more»

To add on, this will let the team and upper management decide whether or not a project is worth following through on if it hits too many road bumps. If there are major set backs that were not planned for…   Read more»

There was a project that I was on that we should have spent more time in the research phase. We were culturing cells for this project and there was one very old article that we found a few weeks after…   Read more»

I work at a very small company so they assume that they do not need to complete WBS at all. So this accounts for everyone taking on more responsibility than is needed and certain things falling through the cracks. We…   Read more»

One of the manufacturing projects that my team works on at my company, was delayed because of an issue in the biology department. The cell biology department had an incubator that was contaminated that killed all of the cells that…   Read more»

Catheter with antimicrobial coating is another example of a combination product. This allows the catheter to function as it is intended but prevents catheter-associated urinary tract infections (CAUTI). This allows the user to use a catheter with the same function…   Read more»

I agree with everything said so far. This is more an example of where having an interpersonal “beef” with another employee caused a long delay in the production at the company I currently work for. There was an issue with…   Read more»

Currently, I work for Scimedx, a small diagnostic medical device company. Since the company is small (only about 30 people) its a little harder to describe how we operate but I think it is closely related to a matrix organization….   Read more»

To add on to what aij5 has said, there is also legal liabilities that companies should make sure that they have covered. If a product goes out to market with known risks and they have made sure that the public…   Read more»

This one might be a layup but a pretty common one would be a first aid kit. They have aspririn and antibiotic cream that would go through CDER which are probably class 2 with 510k. The bandages and gauze would…   Read more»

I think there is the assumption that engineers will be well equipped enough in their jobs that they can learn and evolve throughout the entire process. Interpersonal skills are something that are necessary in every job and for some people,…   Read more»