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Articles

The Agile MedTech Lifecycle: Rethinking Regulatory Adoption in a Time of Global Disruption

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By Arjunvasan Ambigapathy, Six Sigma, Lean Automation
| MedTech Intelligence
Introduction: A Wake-Up Call from Recent History In 2023, Philips recalled over 5 million ventilators globally due to foam degradation linked to potential carcinogen exposure (Source: FDA, 2023). This event underscored a systemic challenge: traditional medical device lifecycles are rigid, slow to respond to emerging risks, and lack real-time monitoring capabilities.
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