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 ...

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...

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...

One of the main reasons people form a corporation is to protect themselves. The company is treated as its own "person" under the law, so if it gets sued or goes bankrupt, the owners only lose the mone...

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 wi...

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 test...

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 c...

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(...

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 mor...

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 ...

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 d...

What I found interesting from this week’s slides was how much the claims made about a medical device can affect its regulatory path. Before this lecture, I mostly thought the FDA classified a device b...

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 ...

Pre-clinical research can happen in both academia and industry, but I often wonder which one contributes more to real progress and what actually drives that contribution: funding or the personal motiv...

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 e...