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About When to Consider Outsourcing Medical Device Manufacturing to a Contract Manufacturer?


Medical Device Manufacturers are grappling with mounting pressures related to cost , time to market , and an increasing stringent regulatory environment. Many of the companies view contract manufacturing as an alternative in one or more of the following situations :

  1. Manufacturing is not a core competency of the organization.

  2. The device requires high development and clinical costs, which may limit the resources required to engage in high quality and high productivity manufacturing.

  3. Their organization’s financial objectives result in the consideration of reducing company overhead, including facility costs or a reduction in labor costs.

  4. Their internal logistics support may not be “optimized” for procuring and handling materials necessary to ensure the safety and efficacy of your medical devices.

  5. Capital equipment ROI objectives are not being achieved or current manufacturing equipment is outdated for the production of highly complex medical devices.

  6. Risk Mitigation - Managing growth effectively by developing partnerships with supplemental resources to support quality and regulatory compliance, economies of scale, as well as disaster and business recovery planning strategies for the customers and investors is a good business practice.

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