I agree that the team matters more than the tool. One thing that makes it worse is the scoring itself. Since an RPN multiplies severity, occurrence, and detection, a failure that could kill someone but is rated as rare can…   Read more»

I like the CAP example because it shows training doesn’t have to be a one-time thing. I agree it’s the weakest control in general, but I think implants are a bit of a special case. With something like a hip…   Read more»

Honestly the first thing I pictured was the attachment flying off while it’s still spinning. With a drill or saw, that could cut soft tissue, hit a nerve or blood vessel, or even leave a piece behind in the wound,…   Read more»

Do you think watching users during early testing is more useful than just asking them for feedback? I ask because what people say and what they actually do don’t always match. A surgeon might call a device easy to use…   Read more»

I think the fact that two surgeons can have different experiences with the same device is actually something you can measure, not a reason to give up on measuring. In human factors testing (IEC 62366 is the standard most of…   Read more»

Design changes and documentation matter because even a small modification can affect a device’s safety, its performance or the way it’s manufactured. I also think manufacturing teams should be part of these discussions. They work with the product hands-on every…   Read more»

In my opinion packaging and labeling deserve as much attention as the device itself, because both have a direct effect on patient safety and on how the device gets used. A device can be designed perfectly and still cause serious…   Read more»

I think it matters a lot to bring different users into the design process early, because they don’t all interact with a device the same way. A surgeon is usually focused on performance and precision. A nurse may care more…   Read more»

@bryan-xavier @james-olson I agree the user need comes first, but I’m not sure “consensus” works as a threshold. A room agreeing the device works is still an opinion. I think the threshold should be something you can check on paper,…   Read more»

I think a lot of the DePuy problem started at the design input stage, before any testing.ISO 13485 7.3.3 says design inputs should include information from similar designs. Metal-on-metal hips from the 1960s and 70s already had wear debris problems….   Read more»

Nobody has picked up the question about sham procedures yet, so I’ll take that one. I think shams should face stricter standards, but it depends on what the sham involves. The fake ultrasound device from our lecture slides is low…   Read more»

I think pz98’s question about blinded trials is the hardest part of this. One thing that helps is being upfront during informed consent that the study is blinded, and explaining that the patient won’t know which treatment they’re getting until…   Read more»

I wouldn’t be comfortable using a device in a hospital if most of its evidence came from virtual patients. A simulation can only model what we already understand about the body, and the problems that end up hurting patients are…   Read more»

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»