Medical device outsourcing is expanding, driven by the need for specialized expertise, cost pressures, accelerated innovation, and regulatory complexities. Lessons from the pandemic emphasized the value of supply chain resilience and robust CMO partnerships, leading to increased focus on risk mitigation, nearshoring/reshoring, and enhanced disaster preparedness. OEMs prioritize CMOs with strong quality systems, regulatory proficiency, vertical integration, and collaborative capabilities like early design involvement (Dfx) and customer obsession. While supply chains have largely recovered, the industry addresses ongoing challenges like labor shortages and evolving trends including digital health, AI integration, sustainability, and alternative sterilization methods.

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