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The Future of Delivering Software as a Medical Device

The Future of Delivering Software as a Medical Device

The Future of Delivering Software as a Medical Device

McKinsey & Company

McKinsey argues that software as a medical device (SaMD) is becoming a critical source of growth, differentiation, and patient value for MedTech, but traditional quality processes can slow software development. Leading organizations are adopting agile, product-focused operating models that embed quality, regulatory, cybersecurity, and risk requirements earlier and continuously throughout development. Automation and agentic AI can further reduce documentation, testing, risk assessment, and traceability workloads while maintaining human oversight for critical decisions. This approach can accelerate releases, increase development capacity, improve audit readiness, and enable faster innovation without compromising safety or regulatory compliance.

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