There were a lot of good suggestions in this thread about methods and tools you can implement in a risk management plan. I saw FMEA, and the bowtie method already mentioned in this thread, which are b...

I agree that a more dynamic approach to each device would be the best way to handle risk management on any individual project. I do think that you are correct, that maybe there may not be enough empha...

I do not think it is really possible to design a zero-risk device. While certain kinds of risks can be eliminated, some risk will always exist in some form. Unfortunately, I think that means that stri...

I think you brought up a great point about validating alternative equipment, in case of equipment failure. I think that in addition to validating alternative equipment, alternative materials should al...

Alot of great points were already brought up in this thread. Trying to keep balance between maintaining up-to-date documentation and balancing inefficiencies, has some challenges. I agree with the app...

While it might be possible that not every real-world failure can be predicted or fixed with design controls, however in this case highlights how design controls are not effective unless there is a wor...

There are many issues and limitations involved with using contract manufacturers. Someone has already brought up ensuring good and consistent QC. Whether you rely on their internal QC or your QC to en...

I generally do agree with the others that one design review is probably not likely to be enough, and while technically following the law is likely not the best idea. Not only will this raise uncomfort...

Others have already mentioned specifics of using documents like the DID, and DSD to turn broad user needs into specific device specifications. However, I believe that more generally speaking, anything...

While virtual trials can help with reaching as many patients as possible, this approach has drawbacks to it as well. The main benefit of virtual trials is of course, the ability to reach the maximum n...

GCP is absolutely necessary because innovation is useless, if the methods used to essentially prove the device are not sound. While GCP does involve much more extra paperwork, that causes things to ta...

I agree with you, that trust is absolutely vital in a clinical study, not only to attract and retain participants, but to also ensure that the patients report honestly. I believe that the best way to ...

I think marketing for medical devices should first and foremost focus on presenting positive patient outcomes. It should especially be emphasized for outcomes that beat out competitors to highlight th...

For dental tools, as someone else has already mentioned, dentists tend to be in small practices that they may own and run themselves as opposed to larger hospitals. This makes marketing to them more d...

@shreya I think you bring up a really great point about how different audiences being important for narratives. I think that different narratives and storytelling styles should be used for different ...