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 require a unique response. A clear chain of…   Read more»

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 difference for biomedical engineering students, not…   Read more»

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 data collection. In some cases, the way a…   Read more»

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 that goes…   Read more»

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’ve gained through engineering with the creative…   Read more»

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 rely on both the product…   Read more»

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 have to post. Without that…   Read more»

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 him and hearing…   Read more»

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 that at the…   Read more»

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 documented. Studies point out frequent findings in supplier management, such…   Read more»

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 recorded so that risks can be tracked and then addressed. I…   Read more»

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 updates, and connectivity, which makes risk management and validation…   Read more»

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 wondering, though, is whether there is any creative aspect…   Read more»

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”, the…   Read more»

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 the approval process can…   Read more»

Biocompatibility throughout a device’s whole lifecycle is tough since the body will always react to foreign materials in some way. Even metals like titanium or ceramics can still cause issues over time. That’s why manufacturers look beyond just the base…   Read more»

One thing I think is interesting when comparing academia and industry is the pace and priorities. In academia, it feels like the goal is more about discovery and publishing. You need to be patient and persistence and be able to…   Read more»

I think everyone raised really good points about cost, time, variability in biological responses, and different supplier issues could all be hurdles in device development. Something I would like to add that was discussed in the lecture videos is that…   Read more»

Something I’ve noticed in my own group projects is how the environment has an impact on whether people actually share concerns or just keep them to themselves. Even if the manager isn’t the more technical person in the room, the…   Read more»

I like all the points that have been made so far, it does feel like academia follows a much more relaxed and less structed project management path than the industry does. This is definitely the case because the industry involved…   Read more»