I agree that clearer limits might help, but one thing that hasn’t been mentioned is how inconsistent a single numerical cap would be across regions. A $100 meal can be modest in one city and unrealist...

One thing I don’t think has been brought up yet is how verbal agreements become risky simply because people change. Teams shift, managers leave, and projects get handed off. Without written documentat...

One thing I think hasn’t been mentioned yet is that a consulting agreement can become risky even when the contract itself looks perfectly compliant. Regulators don’t just look at what’s written, they ...

Another important factor is the extent to which the team's members influence whether leadership or management works better. Different personalities respond to different styles. Some engineers thrive u...

I think a big reason teams struggle to connect Design Controls with Project Management is simply that most engineers were never really trained in PM tools to begin with. Design Controls feel familiar ...

Something I think doesn’t get talked about enough is how much the environment affects whether someone actually feels comfortable speaking up. It’s not always about if we should raise the concern, but ...

One issue I see with depending too much on FMEAs is that they are predicated on the idea that failures occur one component at a time in predictable ways. However, contemporary medical devices do not m...

One thing that often gets overlooked is that risk isn’t just tied to the device design but it’s tied to the patient using it. Two people with the same pacemaker can have completely different reactions...

Sometimes a mitigation doesn’t make the product safer overall, it just transfers the risk to a different user group, workflow, or failure mode. For ex., adding too many alarms on a medical device can ...

Everyone’s shared great technical solutions, but another issue behind documentation fatigue is how people interact with the process, not just the tools themselves. When updates feel like busywork inst...

Everyone’s made great points about prediction limits and company oversight. Another major gap is that verification and validation don’t really reflect real-life patient diversity. The DePuy implants m...

While many have raised valid points about adaptive algorithms and overconfidence in structured systems, I think a modern “Therac moment” could result less from technical gaps and more from ethical and...

I agree with everyone that design controls don’t have to kill creativity - it really depends on how teams use them. One idea I haven’t seen mentioned yet is how design controls can work alongside agil...

I agree that multiple design reviews are needed, especially at major milestones like inputs, outputs, and validation. But to answer your question about how to ensure full traceability, I think the key...

I like how you mentioned the importance of using documents like the DID and DSD to turn user needs into measurable specs. Something that also works great for bridging that gap is Quality Function Depl...