Based on the responses thus far, transparency, bias, and privacy seem to be the three most critical and identified ethical challenges for using AI. I want to expand a bit on the accountability aspect,...

Virtual trials and telemedicine have certainly bolstered the inclusivity of recruitment, but another promising development is the use of real-world data (RWD) and artificial intelligence (AI) to selec...

I agree that patient safety and data integrity are critical to ethical clinical research, and the principles of ICH-GCP certainly operationalize such goals. For example, ICH E6 (R2) emphasizes accurat...

Zoom is a company experiencing rapid growth due to its optimization of telehealth and virtual care. Despite Zoom being originally a video conference platform, Zoom now holds 36% of the US national tel...

AI can certainly transform medical device marketing, particularly when it comes to understanding audience behavior and personalizing outreach. However, I think the real issue is striking a balance bet...

I certainly agree that patient perspectives greatly add value to marketing strategies, particularly as patients are increasingly seen as partners in their own care. However, I also think it's essentia...

I definitely agree that it's unethical for companies to withhold medical devices purely for profit margins; however, I think the issue is more systemic than simply due to corporate greed. The high mar...

Going private can definitely liberate a company like EA from short-term shareholders' expectations, however, I think it also has great potential to inspire greater innovation. Typically, when companie...

If I were starting my own business, I would choose to establish a Limited Liability Company (LLC), as LLCs offer both limited liability protection and simplicity in management. The protection alone of...

I do agree with the emphasis on the balance between QA and QC, but I would like to integrate the discussion of cost and efficiency into the balance. If QA is done well, this would reduce the number of...

@krp67 I found your internship experience at Paramount Metal Finishings quite interesting, particularly the portion where you discuss how QC investigated whether rust issues were caused by drying, hum...

As embedded software is now a critical component of medical devices (e.g., insulin pumps and pacemakers), I have found that quality assurance processes extend beyond just functionality to encompass pa...

Something I would like to introduce to the discussion is the complexity of post-market surveillance and regulation for combination products. Contrasting standalone products (e.g., devices/drugs), comb...

Another important point of delineation lies in the fact that clinical trials for medical devices often incorporate a higher degree of iterative design than for pharmaceuticals. Pharmaceuticals or drug...

These are all great posts covering the various facets of regulation. One point that has not been raised is the contrast of regulation between the United States and countries outside the US. The FDA is...