@aca I don’t particularly think there should be an emphasis on patient diversity as clinical trials are meant to be done for the potential population who will utilize the medical device. If patient diversity is emphasized, companies could lose the…   Read more»

@aca I agree that manufacturers should demonstrate that a medical device can be used safely by healthcare providers with appropriate training before receiving regulatory approval. Even if a device performs well in AI simulations, the results may be different depending…   Read more»

@aca I agree with your point about the root cause still being in the process, and I think high defect rates should absolutely be treated as a warning for the quality assurance system. A high defect rate means the process…   Read more»

@aca I agree with you, and my answer to your question is yes. I think companies should define risk levels ahead of time that require a second review when an AI system and a QA professional disagree. Without them, the…   Read more»

@aca In my opinion, having a tiered second review has merit and is consistent with how regulators view software in quality systems. The greater the impact of the AI tool output on patient safety or product quality, the more scrutiny…   Read more»

@aca I agree with your point that AI-enabled medical systems don’t need to submit entirely new documentation each time there is an update. I think that the degree to which the system must be tested depends on how substantial the…   Read more»

@aca your challenging of the idea that the DHF is the PM’s ultimate deliverable. If a PM’s mindset becomes to produce a perfect DHF, they risk placing too much focus on compliance instead of acting as a proper strategic leader….   Read more»

@aca You raise an interesting issue here, as this is not just a technical setback but a design control and traceability event. With a high risk device like the stent, dissolution rate is not a secondary parameter, due to its…   Read more»