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 as one with no coating on it, but with less risk of infection. This is submitted to…[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 production that most likely could have been solved in about 2 weeks if it was managed by the head of manufacturing, however the…[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. If there is a large product, the people in the microbiology department (my department) will help out whatever other…[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 knows about them and have warning labels and such on the product, they are less liable for legal action against them. If a drug goes to…[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 go through the CDHR and be a class 1 device.

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, these skills are harder to develop than technical skills or knowledge. So if you come out of college with a…[Read more]