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 bu...

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...

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 ...

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 d...

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 ...

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...

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 perfe...

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. ...

@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 s...

This week’s slides list environment of use as one of the main design input questions, next to function and performance. The Philips CPAP recall from June 2021 shows what happens when that input is too...

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 th...

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 f...

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...

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 ...

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 ...