Understand the combined pressure

AI, robotics, and more personalized approaches are expanding product possibilities. Regulatory expectations evolve alongside those technologies, while connected devices, home monitoring, and changing care models reshape demand.

This February 2024 perspective discussed several regulatory topics as they stood at publication. Specific requirements and pathways should always be checked against current authoritative guidance.

Build the ability to adapt

Companies need clear customer insight, disciplined development, and leadership that can make timely choices. Encourage experimentation within appropriate controls and improve product development cycle time without compromising quality.

Resilience depends on shared information, capable teams, and a culture that learns from experience. The strongest response is an organization able to translate new evidence into decisions and execution, rather than a series of disconnected reactions to each technological or regulatory development.

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