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 wa...

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...

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...

Everyone’s shared great technical solutions, but another issue behind documentation fatigue is how people interact with the process, not just the tool...

Everyone’s made great points about prediction limits and company oversight. Another major gap is that verification and validation don’t really reflect...

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

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 ...

I agree that multiple design reviews are needed, especially at major milestones like inputs, outputs, and validation. But to answer your question abou...

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 gr...

One thing I’d add is that CRAs help maintain safety and data integrity not just through monitoring, but through ongoing site training and communicatio...

I think digital tools and AI are helping find eligible patients faster, but one challenge that still gets overlooked is the actual burden of participa...

I feel like biomedical engineers play a more active role in clinical research rather than just a supportive one. Yes, they help design devices and ana...

Dexcom is another company that has been doing great and growing. It’s a business known for its continuous glucose monitoring (CGM) devices, and has ha...

I think your description of it as "serious science meets stand-up comedy" is really accurate. Especially for those who are not very knowledgeable abou...

Differentiation can rely less on the product itself in a time where many devices have similar features/functions and more on how businesses use patien...