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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 :
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Manufacturing is not a core
competency of the organization.
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The device requires high development
and clinical costs, which may limit the resources required to
engage in high quality and high productivity manufacturing.
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Their organization’s financial
objectives result in the consideration of reducing company
overhead, including facility costs or a reduction in labor costs.
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Their internal logistics support may
not be “optimized” for procuring and handling materials necessary
to ensure the safety and efficacy of your medical devices.
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Capital equipment ROI objectives are
not being achieved or current manufacturing equipment is outdated
for the production of highly complex medical devices.
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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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