@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»