In the simulation this week, we were tasked with correcting bottle label failure. When dealing with experiment failure in general, what do you feel is the most effective method for resolution?

There are different ways to get funding for a project depending on the size of the company. It also depends on if the company is privately owned or public. Overall, I would more so look at the risk fo...

Dr. Simon touched upon Design Review Meetings. He gave a strategy of sending documents to the expected attendees ahead of time in order to get a faster approval. Is there any other way that you can th...

Design Verification and Validation should, on some level, be implemented throughout the entire life cycle of a medical device. You should verify that you can make each component of the device consiste...

I don't see global regulation happening. When filling out the different applications with the FDA, there are application fees. If everything becomes global the application fee will change as well whic...

Anthony, The premise of the device is interesting and can provide needed support with suggested treatment. The reason for the disclaimer, in my opinion, is because electronics can fail. If they state ...

The FDA definition for a medical device captures a broad spectrum of products that one may not initially consider a medical device. An example of this would be a bedpan. Although a band-aid is not use...

Picking the proper project team is an essential component of a project. Each project will have multiple moving parts and having a diverse project team will be beneficial. It is important to have a wel...

A project manager needs to be able to make decisions. Communication is an important skill as well, yet without the ability to make a decision a project will fail. Having all of the information in the ...

I believe education is always a proper investment. In order to succeed at anything, you need to know what is going on. How often do you go to a store or a restaurant and immediately notice when someon...

I don't feel the ratio is as literal as it seems. It's not that a certain individual is 30% competent technically, it's that that person's overall success is relying on their technical knowledge 30% o...

When I think of an NDA, I always think of the Krabby Patty formula. Mr. Krabs kept what he wanted to himself inside a bottle in his safe. Everything else that was common, he didn't care about. The sam...

Dr. Simon, Wow ... the semester is already almost over ... I really enjoyed this course. I didn't know about all of the roles that I could have gone into utilizing a BME degree, and I would rather cha...

When entering into a contract, I would dissuade one from relying on a verbal agreement. A contract is similar to meeting minutes if it's not written in the contract, it did not happen. I've seen count...

I work in more of a Project-based Organization. Every hospital is considered a separate account and they run as such. If another account needs help, I can go to that account to lend my expertise for a...