Medical Device Life Cycle Management | Medical Device Design | Integer

Product Life Cycle Management

Integer’s product life cycle management addresses our customer’s challenges by optimizing resources, reducing risk, and lowering total cost of ownership. Our team of experts provides the following services to ensure seamless production during the entire process and create opportunity from multiple vantage points.

  • Optimize resources
    Manufacturing partners that already have facilities, staff, equipment and supply chains in place can begin design, optimization, testing and manufacturing quickly. Likewise, larger outsourced manufacturing partners provide already built-in and scalable manufacturing infrastructure and an established supply chain to allow the OEM to avoid replication that could be costly and require 12 to 18 months of activity.

  • Reduce risk and improve continuity
    A complex medical device may call for hundreds of components and materials, each with specific requirements, associated standards and applicable regulations. In particular, the environmental movement has added requirements for reduction of hazardous materials and specific guidelines for disassembly, recycling, and disposal. In contrast, large, global design, and manufacturing services companies typically have robust supply chains that they qualify, strictly monitor and proactively manage on an ongoing basis. Leveraging its partner’s vertical integration helps the OEM streamline production. Further, thanks to high purchase volumes, economies of scale and global scope, an OEM’s partner can often drive down costs and optimize supply chain management more effectively than the OEM itself.

  • Lower total cost of ownership
    Transferring a product line to an outsource manufacturing partner not only provides the opportunity for seamless extension of your in-house manufacturing capabilities, but also transfers direct and indirect costs to produce a product to your external partner. This increases the flexibility helps you avoid the need to scale facilities and staff up and down, making it easier to balance priorities.

Product Line Transfer

  • Feasibility and risk assessment
  • Project planning and scheduling
  • Process and tooling development
  • Supply chain adoption
  • Component insourcing
  • Product equivalency

Prototype-to-Production Migration

  • Design for Manufacturability (DFM)
  • Design for Assembly (DFA)
  • Bill of materials insourcing and outsourcing
  • Custom tooling and fixturing
  • Process development and scale-up production
  • Scale up and transfer to low-cost manufacturing
  • Quality system management

Line Duplication

  • Feasibility and risk assessment
  • Project planning and scheduling
  • Process and tooling duplication
  • Line duplication/expansion-to-scale production
  • Process improvement
  • Product equivalency

Dedicated Transfer Team

Customers benefit from our centralized transfer project management team. They direct the execution activities handled by site-specific project teams at the sending and receiving sites. Integer recognizes there are differing organization structures assigned different responsibilities within the customers we work with. Our playbook is structured around each type of work reflected in the work breakdown groups (not function) across the phases of the project. The individual owners of each activity and deliverable are defined at the planning phase.

Example of a Targeted Functional Representation

  • Product Planning
  • Optimization, Ramp-Up
  • Commercial & Legal
  • HR & Communication
  • Quality Systems & Regulatory
  • Supply Chain & Procurement
  • Operations & Manufacturing
  • Information Technology
  • Engineering