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, and no model captures…   Read more»

@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 treatment assignment stays hidden. A…   Read more»

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 trials. I think it…   Read more»

@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, maintenance, disposables, and whether insurers will…   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»

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 to report their financial information every quarter and…   Read more»

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 it does. A high debt ratio…   Read more»

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 injure a patient and lead…   Read more»

@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 rate means the process…   Read more»

@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. Without them, the…   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»

@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 situations where their involvement does add more time, especially if the…   Read more»

@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 claims from the beginning rather…   Read more»

@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 introduces a small change that does not…   Read more»

@dmcclee I totally agree with your point, but unfortunately, as we learned from today’s module, industry does not always set deadlines based on the amount of time the science actually requires. Sometimes deadlines are established for business or project-related reasons,…   Read more»

I really enjoyed this topic because I was actually thinking about this question while going through this week’s module. I believe the decision ultimately depends on the resources available and how much time you have to complete the research. Each…   Read more»

I also lean toward industry being a stronger contributor to research than academia. I feel like I learned a lot from Dr. Josh Simon’s module this week because it showed me a side of research that I had not really…   Read more»

I totally agree with the perspective that project management skills can benefit people working on a project and are not necessarily only useful for those in leadership positions. I believe having these skills can help people work more effectively with…   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»