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Effective Vendor Management For Medical Device Industry
Medical device manufacturers rely on suppliers for many
things. Choosing the right vendors and managing them
effectively can increase a manufacturer’s efficiency - in
terms of time, cost, and quality. Unfortunately, suppliers
can also sometimes put their clients in hot water when
their quality standards are below par.
There are a lot of contract manufacturers that are
shifting their focus to medical technology due to the
stability of the marketplace as compared with the
automotive or aerospace industry. While many of them have
good intentions, they often don’t understand the
complexities of medtech manufacturing.
However, for Medical Device Manufacturers, their suppliers
are their partners. Although they are ultimately
responsible for complying with regulations and standards,
their vendors should provide support by being compliant
themselves.
The manufacturer of the finished device - not the
supplier - is responsible for compliance. However, the
regulations also specify that device manufacturers should
select only suppliers with the capability to provide
quality products. It is said that, “Quality cannot be
inspected or tested into Products and Services. It must be
built into device.”
Medical Device Manufacturers should identify suppliers
that have a successful track record in the device
industry. They should be competent to satisfy quality and
regulatory needs.
Purchasing Controls: It is necessary to establish and
maintain quality requirements for suppliers, vendors, and
contractors.
Medical Device manufacturers should evaluate and select
potential suppliers, contractors, and consultants on the
basis of their ability to meet specified requirements,
including quality requirements.
The major issues that impact a device manufacturer’s
Compliance efforts are:
1 Vague Quality Requirements: Not having quality
requirements for suppliers is one of the major problems.
Working closely and collaboratively with suppliers in
creating and documenting the criteria is very essential.
This result in making suppliers part of quality process
which in turn results in better quality for your
materials/components. It will also help manufacturing to
produce high quality products at reasonable cost.
2 Participation in Validation: It is god to prefer
suppliers that implement meaningful validation program.
This along with strict change control is very essential.
It is also necessary to ensure that suppliers are
notifying us of any changes that take place in material
and/or processes.
For, effective Vendor Management, some of the important
considerations are:
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Getting the right references from the suppliers.
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Installing good software system to have a robust audit
program.
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Use of latest technology to incorporate purchasing
controls in the Quality Management Systems (QMS)
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Ensuring that the suppliers and their
suppliers/subcontractors are in harmony and the suppliers
have control over their outsourcing process.
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Medtech Companies Need Collaboration With External
Partners For Innovation And Growth
As per a recent global study by
“PwC Health Research Institute”, Medtech executives
are beginning to appreciate that innovation must occur
outside of traditional research and development units,
they cocreate - that is, they involve customers or
external partners from idea generation to execution -
on onethird or less of their products and services.
Most Medtech companies identify “open innovation” -
external and internal people generating and
commercializing ideas together - as one of the top two
approaches that will generate the most growth. Nearly
81% of executives have plans to collaborate with
strategic partners during the next three years, but
more than half said a major challenge is finding the
right partners. How they collaborate with these
partners will be key. |
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