I think having a standardized process for handling adverse events is essential, but it should also include build-in flexibility. Each trial is different, and the severity or nature of an event might r...

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 time in a clinical setting would make a big differ...

I think another interesting angle that hasn't been mentioned yet is how the placebo effect can actually reveal the power of patient-clinician interaction rather than just being seen as an obstacle in ...

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 placement, but at the end of the day it's the product tha...

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 would be a great way to blend the technical knowledge ...

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 last for years, and customers need to know they can ...

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 than worrying about the quarterly profits they ha...

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 creating websites for clients, and after talking to...

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 classmate the other day and they were mentioning tha...

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 changes or complaints back to something they documente...

Quality assurance can also make sure Class III devices meet safety standards by focusing on strong documentation and traceability during design and development. Every change and decision should be rec...

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 simply hardware anymore, they have AI, software u...

I've also been interested in regulatory affairs since this class started, especially because Professor Simon keeps mentioning how it's a growing field with a lot of job opportunities. What I keep wond...

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, but they need to know the "rules of the game", th...

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 productive. One challenge I think is about how long t...