I would consider user training as part of mitigation, where it doesn't necessarily reduce or transfer the risk, but it aims to reduce harm. While training is definitely needed and is helpful in reduci...

I disagree with the comments saying that accepting a risk can increase the probability. I feel like if it had any effect on probability, accepting a risk would lower the likelihood of harm occurring b...

I agree that patient variability plays a huge role in how a device performs and that diversity is really important during clinical trials. Lab testing can only tell us that the device was "built right...

I agree that packaging and labeling are more important than one might think. I do believe that label and packaging durability need to be part of safety testing. For things that need to remain sterile,...

I agree that "user" is a very broad term and it can be difficult to include everyone and ensure "user ease" for all. Aside from verbal feedback from users, companies can also use physical prototypes o...

It is incredibly difficult to establish and maintain trust when it comes to a double-blind study, as it is quite literally impossible for doctors to tell their patients all of the details, as they the...

While I do not think there is necessarily anything wrong with selling a placebo treatment if it has been proven to speed up recovery, I do think it is wrong if there are other treatments on the market...

I agree that AI models are not as reliable as human trials, but they may be more useful in early development. However, I could see it being more beneficial in the future. As previously mentioned, AI m...

This is a great question, however the answer is deeply complicated. As many have previously noted, if those in leadership positions rush a product and it results in safety issues, or they ignore conce...

I feel like I would factor the type of company into my decision when accepting a job offer, as it can impact job security and project longevity. A partnership is risky since it dies when a partner die...

If I were starting a medical device company with the goal of it lasting long-term, I would definitely go with S-corp. An S-corp is more stable in the sense that shareholders leaving or dying will not ...

I understand where everyone is coming with as far as the whole "use AI to speed up quality inspections" thing, however I feel like it would take a significant amount of time to train AI to ensure it i...

I agree that QA and QC are extremely important. I honestly was under the assumption that working in these departments was one of those boring, unwanted jobs that is not very meaningful compared to oth...

I was actually under the same impression as well! While Regulatory Affairs does in fact do a lot of significant work after the product is developed and being used, I think the work that they do behind...

I see a lot of people discussing covid and how the outbreak could have been prevented or controlled better, but honestly, I disagree. Clearly there was a sense of urgency given the situation, however ...