I think surgeons should definitely be compensated when they're actually helping develop or improve a medical device. They're providing their experience and knowledge, so I don't really see anything wr...

I think getting feedback from physicians and patients is really important, but I also wonder if just asking people what they want is always enough. Sometimes people get so used to doing something a ce...

I think all four are important, but I would probably lean more toward placement, especially when it comes to medical devices. I know most people mentioned product or price, which definitely makes sens...

I think something else worth considering is what happens after the product is sold. I agree that a company with better marketing can probably sell more devices even if its product isn't necessarily th...

I think outsourcing can definitely help a company save money, especially when it's still growing and doesn't have all the resources to do everything itself. But something I wonder about is whether com...

One thing from this week's lecture that got me thinking was how companies decide whether something is worth investing in. I never really thought much about the financial side of these decisions, espec...

I think one thing that makes this topic interesting is how much influence executives can have on decisions without actually being involved in the day-to-day work. Working in manufacturing, I've realiz...

I think it actually makes sense for a company to start with one business structure and change it later as it grows. Especially for a medical device startup, where the company might spend years develop...

I think quality should be everyone's responsibility, but I don't think that necessarily means everyone should have the same authority when it comes to quality decisions. Working in manufacturing has m...

I think another reason QC might get more attention is because QA can sometimes feel less visible to the people actually doing the process. Working in manufacturing, I can physically see when something...

I agree that the QA professional should probably have the final say, but I also think the disagreement itself shouldn't just be ignored after the decision is made. If the AI keeps identifying somethin...

I think there should be an easier path for novel devices that are clearly lower risk. I understand being more cautious when there isn't a predicate device to compare it to, but at the same time, being...

I think your point about how strict "substantially equivalent" should be is interesting. Something else that made me think about this differently was the reading for this week. If a new device is clea...

One thing that caught my attention from this week's lecture was when Dr. Simon talked about how product claims can actually affect the regulatory pathway. I honestly never really thought about that be...

I can see your point that Regulatory Affairs represents the company when communicating with the FDA, but I don't know if I would separate protecting the company and protecting patients that much. I th...