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»

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 something that the QA person doesn’t see,…   Read more»

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 new doesn’t automatically…   Read more»

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 cleared based on a predicate, and that…   Read more»

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 think in a regulated industry those two…   Read more»

This is an interesting question because I don’t think there is ever a point where researchers can say they have eliminated every possible risk before going into human trials. To me, the decision is more about whether enough evidence has…   Read more»

Having worked in manufacturing previously, I believe in addition to cost, equipment and timeline, I might consider how much control I want to have over the research process. Being in a highly regulated industry has helped me to understand that…   Read more»

I believe both passion and funding are equally important; however, I do not believe that it is necessary for academia and industry to compete on who contributes more to each of them. To me, they represent different stages of the…   Read more»

I think technology can definitely make project management easier, but at the same time, I feel like it really depends on how people actually use it. From working in manufacturing, I’ve realized how important communication and documentation are when different…   Read more»