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Sterilisation
In
India, manufacturers have continued to employ two
standard sterilization processes for the majority of
medical devices processed worldwide: gamma and
ethylene-oxide (EtO) gas diffusion.
EtO,
the oldest of the technologies, continues to flourish
as a robust and flexible 21st-century method of
industrial sterilization of medical devices.
New
regulations
Although the highly reactive nature of the EtO
molecule (epoxy ring molecule) offers an excellent
method of sterilisation, it also presents a
significant number of regulatory challenges. There are
currently two International Organisation for
Standardisation (ISO) standards that are in the
process of being changed. These changes will affect
the sterilisation of medical devices using EtO gas.
Medical
devices used for short-term duration (24 hours) will
need to conform to significantly reduce residual
criteria prior to release for patient use. Without
significant changes to the sterilisation process or
ventilation of the packaging, the medical device
manufacturer can expect an extension to product
quarantine time pending the necessary EtO residual
levels being met.
Planning Ahead
From a manufacturer's perspective, it is critical to
prioritize the most important needs and to articulate
those to the contract manufacturer. To be successful,
both device companies and contract manufacturers will
become increasingly focused on anticipating market
needs.
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Following questions should
help medical device companies find common ground with
their outsourcing partners for mutually beneficial
collaborations:
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What is your company's specialty area (e.g.,
cardiology, dialysis, anesthesia, home healthcare,
etc.)?
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Is the device to be developed or manufactured Class I,
Class II, or Class III? The class affects the device's
development, regulatory pathway, financial liability,
and
complexities.
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What gaps do you need
your partners to fill (e.g., engineering resources,
distribution, packaging, or finished-device
manufacturing) awaiting?
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Is the quality system of the contract manufacturer
sufficient for the device being manufactured? Both the
contract manufacturer and medical device company
should do a gap analysis of their quality systems.
Mutually agreeing on what needs to be included in the
quality system of the contract manufacturer should be
done before manufacturing begins.
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How will the transfer of developed products to
manufactured products be managed? Using one company
for development and another for manufacturing can
complicate the process and can increase time to
market. It is important to ensure that engineering
designs created in the development phase support
designs for manufacturability.
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What are the current and expected national and global
demands for the finished device? If demand is expected
to increase, then device companies should request
year-over-year pricing decreases. However, if demand
is expected to fall, be prepared that a contract
manufacturer may expect year-over-year volume
commitments.
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What are the current and expected average selling
prices (ASPs) for the finished devices? (Low ASPs
generally equate to high-volume production.) Does the
contract manufacturer have access to low-cost
manufacturing?
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