I think this is a good question because honestly, some things are just difficult to measure, especially when it comes to comfort or how easy something is to use.I agree that user needs should be measurable, but I also think…   Read more»

I think this is a really interesting question because realistically, there’s always going to be something that can be improved in a medical device. But does that mean engineers should keep making changes every time they come up with a…   Read more»

I agree that both verification and validation are important, but one thing I was thinking about is how much trouble could be avoided if the people actually using the device were involved earlier in the process.Since I work in manufacturing,…   Read more»

I agree that having multiple design reviews is important, but I also feel like the number of reviews doesn’t always tell you how effective they actually are.One thing I’ve noticed from working in manufacturing is that sometimes everything looks good…   Read more»

I think this is a really good point because sometimes what engineers think is a great design might not necessarily be what the people using the device actually need. I feel like it’s easy to focus on making something more…   Read more»

I found this part of the lecture pretty interesting too. I honestly didn’t realize how different verification and validation were until going through this week’s material. I feel like both are equally important, but it also depends on what kind…   Read more»

I think this is a really good point. Working in manufacturing, I’ve seen how even small changes can sometimes affect a lot more than people initially expect. Something that might seem like a simple adjustment could end up requiring changes…   Read more»

One thing that stood out to me from this week’s lecture is how many different people and groups are involved in clinical research. I honestly didn’t realize how much coordination goes into a clinical trial beyond just testing a treatment…   Read more»

One thing I was thinking about while reading everyone’s responses is that building trust when everything is going well is probably the easy part. I feel like the real challenge comes when something unexpected happens during a clinical trial.Coming from…   Read more»

I think AI could actually be really useful in clinical trials, but maybe not necessarily by replacing human participants. Something I was thinking about while reading everyone’s responses is whether AI could help reduce some of the risks that patients…   Read more»

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 wrong with that.But what I find interesting is how difficult it…   Read more»

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 certain way that they might not even…   Read more»

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 sense, but I feel like having a great…   Read more»

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 the best one out there. But I…   Read more»

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 companies always consider the extra work that comes…   Read more»

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 realized that decisions made at the management level can eventually…   Read more»

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 developing something before it even starts…   Read more»

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 made me see the difference between the two.For example, as…   Read more»

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 is being checked or when a result…   Read more»