@ahmed-elmonier I feel like sometimes one can get away with not involving manufacturing until the later stages of medical device development, but I also feel like they can offer firsthand experience in medical device production. They could help identify practical…   Read more»

@ahmed-elmonier In cases where a medical device passes verification but fails validation, then the first step should be determining if the issue is the design itself, the process, or the original requirements. It is important to understand that human error…   Read more»

@ahmed-elmonier I agree that asking people what they want isn’t always enough, and your manufacturing example makes the point well. I think companies should do both, but I’d lean toward observation as the better way to find problems and use…   Read more»

@ahmed-elmonier I agree that performance matters more over time, and I like your point that marketing doesn’t stop once the product is sold. I think a strong marketing strategy can carry a company for a while, but I don’t think…   Read more»

@ahmed-elmonier I agree with your point about separating who owns quality from who has final authority, and I think that answers your question. Yes, I think employees would take quality less seriously if they saw it as only the QA/QC…   Read more»

@ahmed-elmonier Disclosure of finances is important, but I don’t think it’s enough by itself. Even if the surgeon is completely honest about the financial relationship with a company, the relationship will always influence how they will view the medical device,…   Read more»

@Ahmed-elmonier, good point about claims changing the pathway. It connects to what we talked about with the 510(k) process. To get cleared, a new device has to be shown to be similar to a device already on the market, and…   Read more»

@ahmed-elmonier The FDA should definitely consider the specific kinds of risks a potential new device can pose when deciding a new pathway. Certain risks can be easily detected and controlled compared to other risks. For instance, if there is a…   Read more»

@ahmed-elmonier I would definitely say the level of evidence needed before moving on should depend on the details of the condition. For example, if a new technology is being developed to potentially reduce the deterioration of a degenerative muscular disease,…   Read more»

@ahmed-elmonier I wouldn’t use an outside lab for industry for the reason you mentioned, the reduced control and monitoring over the lab. For projects to maintain consistent deadlines, adding a non-affiliated entity to the project has increased potential for miscommunication…   Read more»

@ahmed-elmonier I agree with your point that a safety concern does not always mean the entire project needs to stop because a safety concern does not necessarily affect every part of the project. I believe that the project manager should…   Read more»