An important dimension to consider is how risk-based approaches guide companies in retrospectively building a DHF for legacy products. Legacy devices already have a level of technical documentation, h...

The Therac-25 disaster serves as a poignant reminder of the vital importance of design controls and verifications in medical device development. I realize that modern frameworks (e.g., IEC 62304 and I...

I wanted to add that the way design controls are perceived also goes a long way. A lot of tension is generated, I think, when design controls are viewed simply as a regulatory burden rather than a way...

When transferring design controls to a contract manufacturer, it is critical to maintain traceability and design intent throughout the production process. Even if contract manufacturers have strong QC...

An interesting perspective is how emerging development models (e.g., human-factors-driven design) are reshaping the distinction between verification and validation. In traditional systems, V&V has...

Another perspective to consider is how regulatory and ethical obligations can affect the balance between user needs and business constraints. In other industries, such as consumer technology, compromi...

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...