I don’t believe that a device with excellent virtual results but little testing on real people should be used in a hospital. A virtual patient is only as reliable as the data and assumptions behind it...

@pz98 I agree with your point about explaining why blinding matters without making patients anxious. I think the key to trust in a blinded trial is being open about the process itself, even though the...

You did a good job showing how many roles have to work together, and I think the part of your post that matters most is the question of whether true informed consent is possible in technology-driven t...

@aysegultinas I like your point about total cost of ownership, because it changes how I think about price. I was picturing the number on the quote, but a hospital is really judging training time, main...

@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...

@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...

I think a medical device startup would benefit more from staying private during product development, and I think the points from the lecture explain why. The lecture showed that public companies have ...

As a biomedical engineering student who hopes to work in this industry someday, I would lean toward continuing to invest in the promising product, but only if the company can keep itself stable while ...

I would prioritize the liability protection of an LLC, even on a limited budget. The main reason is that medical devices carry a different kind of risk than most startups. A device that fails can inju...

@aca I agree with your point about the root cause still being in the process, and I think high defect rates should absolutely be treated as a warning for the quality assurance system. A high defect ra...

@aca I agree with you, and my answer to your question is yes. I think companies should define risk levels ahead of time that require a second review when an AI system and a QA professional disagree. W...

@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...

@31623940 I totally agree. I also wanted to add that I don't necessarily think involving regulatory professionals early in the process would unnecessarily slow down development. There may be situation...

@dcapera I see your point, and after thinking about it more, I agree that starting with fewer claims probably makes more sense. My initial thought was that it might be more efficient to make broader c...

@ma3295 I agree with your point. I think requiring every AI update to go through the same regulatory process as a completely new medical device could become redundant, especially when the update only ...