I recognize storytellers need an angle to make a compelling story and each of these chose a negative slant to highlight issues.

Unless it's fantastic, the content will be ignored. As patients – every one of us – the content is relevant and compelling and, in my opinion, needs to be told.

Do you see it otherwise, @Lena?

After seeing the Bleeding Edge, although it is very slanted against business and quite frankly the FDA, it did remind me of the somber nature of the work we do and striving to ensure that devices are safe and effective and that we have sound scientific data to back up the product and its claims. It will also be interesting to see the continued FDA evolution and response to the attacks on the FDA as well. Wondering if the EU MDR is a foreshadowing of what could be here in the US in the future. Just a thought.

The new EU regulations were criticized from day one by Notified Bodies as being a political, knee-jerk reaction that would not actually address the actual problems that we are trying to prevent. The additional post-market surveillance requirements in the EU should help in theory, but we won't know until we actually see a EUDAMED database that shares the post-market surveillance data. Consequences of the new EU regulations will be big increase in the cost of medical devices and decreased competition. The US FDA is reforming the 510(k) program, but I do not believe they will prevent the scandals that have been publicized. The FDA regulatory process is not capable of preventing all bad products from entering the market. The focus needs to be on gathering better post-market surveillance, benchmarking data against other products, and quickly removing bad products from the market. None of the FDA reforms are suggesting a dramatic increase in clinical data required for the 510(k) process--one of the more onerous requirements of the EU regulations. The FDA has also been systematically been deregulating low-risk devices by making Class II devices exempt from the 510(k) process where they can. The EU regulations are actually increasing regulations on Class I reusable instruments. The EU regulations are increasing unannounced audits, while the FDA is moving towards MDSAP. I would characterize the FDA approach as modernizing and it is driven by the FDA internally. The EU approach is driven by politicians rather than Notified Bodies and Competent Authorities. It's still too early to see if the mechanisms provided to adjust and change the regulations will be effective at helping solve implementation problems.