I think having a standardized process for handling adverse events is essential, but it should also include build-in flexibility. Each trial is differe...

I really agree with what a lot of people here have said about the gap between classroom learning and real-world clinical experience. I think spending ...

I think another interesting angle that hasn't been mentioned yet is how the placebo effect can actually reveal the power of patient-clinician interact...

To agree with many others, I think the product is overall the most essential part of the four P's. You can have the best promotion, price, and placeme...

If I were to transition out of engineering, I'd probably lean toward marketing, especially since I'm pursuing a business minor. I think marketing woul...

I totally agree that the building trust is the biggest part of being a successful sales rep in the medical device industry. These relationships can la...

Going private can be a good thing for a company like EA that you mentioned because it gives them more freedom to focus on their long-term goals rather...

I think most people choose an LLC over an LLP because of how much simpler and more flexible it is to manage. My brother actually started his own LLC c...

I was also shocked when the Professor dropped this fact in the lecture video, 80% seemed really high to me for a medical device. I was talking to a cl...

From what I've read, one of the most common issues during QMS audits is weak traceability, especially when companies can't clearly connect design chan...

Quality assurance can also make sure Class III devices meet safety standards by focusing on strong documentation and traceability during design and de...

I think the biggest challenge right now is keeping quality control up to speed with how quickly medical device technology is advancing. Devices aren't...

I've also been interested in regulatory affairs since this class started, especially because Professor Simon keeps mentioning how it's a growing field...

I like how you framed this because it made me think of how it really is all about balance. I agree that engineers don't need to be regulatory experts,...

I think the FDA has a difficult position of wanting to encourage innovation while also making sure the devices are not going to cause harm and are pro...