As previous posts have stated, packaging and labeling are just as important as the medical device itself. One aspect I would add is that packaging should also be considered throughout the entire lifec...

I think one of the biggest challenges is that engineers can sometimes focus too much on meeting the technical requirements that they overlook how the device will actually be used in a real-world envir...

I agree with both responses that safety and reliability should remain the priority, especially because even minor design changes can introduce risks that were not present in the original device. I als...

One of the best ways to attract participants besides money is to make the study more convenient and provide them with benefits. For example, offering transportation reimbursement, flexible appointment...

AI assisted virtual trials could be useful during the early stages of medical device development but I would not feel comfortable using a device in a hospital if it has only been tested virtually. One...

I understand the argument that a single blind study should be enough, especially if the investigator has no intention of influencing the results. However, I think double blind studies are important be...

I think medical device companies can make sure they are meeting actual needs by focusing on three things. First, they should communicate directly with physicians and patients to understand the challen...

I think price has the greatest influence on whether a hospital adopts a new medical device because hospitals have to consider their budgets and whether the benefits justify the cost. Even if a device ...

Advertising is a crucial component of marketing, however memorable ads are subjective and highly depends on each persons interests. The most memorable ads are those that increase the value of a compan...

I was also surprised after hearing the 80% statistic in this weeks lecture. There are a lot of great points in this discussion thread regarding the ethics behind shelving a medical device just cause i...

The aspect of limited liability is something that has always bothered me about corporations, especially those whose leaders and/or decision makers get no punishment after harming the public. Corporati...

I was intrigued by this discussion thread because I know very little about the business side of medical device companies and this weeks lecture helped me better understand it. From what I learned, it ...

Like most other posts, I believe that the final decision should be made by the QA professional. From what I have learned, AI tools are increasingly being used in medical device companies, specifically...

I think the original post is phrased in a way where we have to pick which option is better and dcapera does a great job of breaking down the differences between each role and their contribution to the...

I agree that companies may be more likely to focus on QC because catching defective parts gives an immediate measurable result while the benefits of QA are harder to see since they involve problems th...