White Paper: Manufacturing & Prototyping

Life Cycle Support for Medical Devices

Part 2: Team integration enables manufacturers and suppliers to use each project as a springboard to the next, keeping the R&D pipeline full—and profitable


Addressing unmet clinical needs while also keeping an eye on the competition requires medtech manufacturers to adopt a structured approach that supports the development of new technologies. An extraordinarily successful example of such an approach took flight in the 1990s, when Bard Access Systems (BAS) partnered with Flexan, a full-service contract manufacturing organization (CMO) specializing in product development and cleanroom manufacturing of silicone and thermoplastic components. This two-part paper describes how BAS and Flexan applied a life cycle approach to the development of surgical catheters and specialized products for vascular access, enabling BAS to maintain its market leadership for more than a decade. Here, Part 2 looks at how medtech manufacturers and CMOs can apply a product life cycle model to support ongoing innovation.

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