I agree with the replies above that paying a surgeon for design input or testing is fair, while paying them per device sold is not. But I think the line is blurrier than it looks. A surgeon who spent two…   Read more»

I think most of the responsibility has to sit with the company, because they’re the ones holding the test data. A surgeon reading a brochure can’t see what was left out. The Kimberly-Clark and Halyard gown case mentioned earlier in…   Read more»

I’d put price first, with one condition: we have to mean total cost of ownership, not the number on the quote. Hospitals run on thin margins, and a purchasing committee has to defend every acquisition. The purchase cost is part…   Read more»

I think structure and freedom affect creativity and productivity at different stages of a project, which is why neither setting wins outright. Freedom helps most at the start, when you’re coming up with ideas. In a lab, you can follow…   Read more»

Everyone here is focused on double taxation, which only matters once a company is making money. A device startup might go five or more years without revenue while it builds prototypes, runs bench testing, and works through the FDA. The…   Read more»

I agree with dcapera that this isn’t really an either/or question‚ but I’d push a little further on why independence matters so much in this industry specifically․ Engineers‚ no matter how much they care‚ will always have a bias towards…   Read more»

I think this thread shows that the real issue may not be whether QC is necessary, but how and when testing is done. DarshP’s point about using similarity to approved devices connects to the FDA’s 510(k) pathway, where some devices…   Read more»

A lot of companies are resistant to QA‚ but QC has a pretty immediate payback: You inspect a batch and you can point to a defect rate going down․ But QA is much harder to “see” working․ If I spend…   Read more»

The FDA classification system still works pretty well overall, but newer technologies make some of the categories harder to apply. Software, AI, and connected devices can create serious risks even if they are not directly interacting with the patient. Should…   Read more»

I think it would be more effective for engineers to have a proactive way of keeping up with regulatory changes rather than only reacting once a change starts affecting a project. At the same time, I don’t think engineers should…   Read more»

When Dr. Simon says “research model,” I took it to mean the model being used in the research design. Since he says to do a literature search first and be able to justify the model you choose, I think this…   Read more»

I agree that we need to innovate‚ but I do not therefore agree that we should shorten the testing process to get new materials to patients more quickly․ A better way forward is a more risk-based and efficient testing process․Pre-clinical…   Read more»

The timetable is only one aspect of the project‚ and a project which is delivered on time may not be ideal․ And an open issue in the compliance or safety world can be a much more serious problem later on…   Read more»

In my opinion starting with a simpler tool can be helpful when someone is still learning project management, because it gives them time to understand task tracking, deadlines, and team responsibilities without too many extra features. But I also wonder…   Read more»

I think the point that you brought up there about intellectual property is a really good one because medical device development is so much more than just having a good idea․ It’s easy for biomedical engineers to think about whether…   Read more»

Hi Ahmed, I liked your topic and wanted to said couple things.I had a similar reaction to the first lecture. What stood out to me was that the course seems focused less on memorizing information and more on understanding how…   Read more»