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 reducing harm, it is not as impactful…   Read more»

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 because acknowledging a risk gives you…   Read more»

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,” but diverse clinical trials tell…   Read more»

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, having a secure packaging that…   Read more»

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 or digital mockups in a…   Read more»

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 themselves are not informed. I think…   Read more»

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 that can…   Read more»

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 models are only limited…   Read more»

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 concerns that are brought up for the…   Read more»

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 dies, and the…   Read more»

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 affect it. It also…   Read more»

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 is accurate…   Read more»

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 other positions within the field of…   Read more»

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 the scenes before…   Read more»

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 it is critical that companies take…   Read more»

As much as I love animals, I do believe that human life is more important than animal life, and I do not think that animal testing can be “a thing of the past,” at least not any time soon. Unfortunately,…   Read more»

I agree with you on preferring to do research in industry where we can see the results of our work in our lifetime. I do admit that it is a bit selfish of me, but I will say that I…   Read more»

While I am a huge animal lover and I honestly do not like the idea of animal testing, I believe it is necessary. Running simulations and doing calculations alone can only get us so far. In my experience with running…   Read more»

I agree that disagreements are bound to happen, but discussing different ideas and perspectives is often a positive. Although it is sometimes time consuming, finding a compromise is typically not that challenging, at least in my experience working in groups….   Read more»

While being organized is extremely important, I do believe that being a team player, keeping everyone motivated, and handling stress well is the key to being a good project manager. In this position, you have to work well under pressure…   Read more»