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Executive Brief: Scaling Software as a Medical Device

Software velocity is not simply a development challenge. It is becoming an enterprise capability.

Software is increasingly driving differentiation, recurring revenue, and customer value in MedTech. But many organizations are still trying to develop and release software through operating models designed for long-cycle hardware.

The result is a growing mismatch: agile software teams operating inside rigid funding models, sequential quality processes, and late-stage regulatory gates.

This Executive Brief examines what it takes to close that gap—drawing on McKinsey’s analysis of the future of…

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