comes to tooling expenses.”
“At times, OEMs don’t fully examine the effect to their CMs when they
change SOPs or elements of their quality systems. These changes may
have major impacts on the way business is conducted between the two
parties if not considered and planned up front. It would not be uncommon
to cause a supply interruption or unintended regulatory consequences,”
Springett adds, “Some OEMs have the misconception that all CMs are
equal. This is not the case. The OEM needs to take into consideration the
manufacturing expertise of the CM, such as, ‘Can they achieve the difficult
but strict dimensional requirements? If the CM is using different facilities
to manufacture various parts of a device, are all facilities following the
same quality manual, and will it have an impact on time to market?’ OEMs
should also ensure they are looking at a true apples-to-apples comparison
when evaluating quotes from multiple contract manufacturers. The OEM
needs to confirm upfront what is included in a quote and any additional
expenses they may incur prior to program launch.”
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Developing a medical device from beginning
through manufacturing to sales and distribution can be a daunting task for any medical
device manufacturer to do on its own in
today’s business environment. While it is
difficult to select the right partner to aid in
this task, doing so can alleviate the aspects
where an OEM is not an expert, enabling
the company to focus solely on those core
competencies in which it is an expert. Additionally, partnering with a CM can eliminate
the need to hire additional personnel, invest
in capital equipment, or relocate to larger
facilities. Being able to have a company help
get to market faster can be the difference
in being first to the market with a device.
Finally, having a company that is intimately
familiar with the strict regulations that are put
out by the FDA may prove invaluable should
they find something in the design that could
have potentially caused a recall years down
the road. Contract manufacturers are a valuable tool available to medical device OEMs,
capable of making the difference between the
success and failure of a medical device. But
keep in mind that not all CMs are equal so
OEMs need to ensure they really put in the
required time when making their selection for
a strategic partner.
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[Editor’s Note: The full responses from
the Q&As with the participants for this
Roundtable feature will be posted as
blogs on the MDT website. You will
be able to view them at
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