White Paper: Manufacturing & Prototyping

Life Cycle Support for Medical Devices

Part 1: The specialized skills of contract manufacturing organizations play a vital role in supporting the work of serial medtech innovators

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For medtech manufacturers, engaging an experienced contract manufacturing organization (CMO) as a product development partner can reduce time to market while ensuring compliance with applicable regulatory requirements and best practices. This two-part paper examines the long-term partnership between Bard Access Systems (BAS) and Flexan, a full-service CMO specializing in product development and cleanroom manufacturing of silicone and thermoplastic components for medical technologies. Beginning in the 1990s, the partners’ approach to product innovation resulted in the creation of many market-dominating generations of surgical catheters and specialized products for vascular access. Here, Part 1 examines the role of specialized CMOs in supporting innovative medical technology companies.

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