|
The
several areas for outsourcing include finished device
manufacturing, component manufacturing, and product
development, including parts acquisition and prototype
design and development.
The Supplier as Consultant
Quite often, medical device manufacturer does not have
expertise in designing of critical components or
sub-assemblies. Taking help of the suppliers helps.
However it is generally not within the scope of the
customer service for the supplier. Sometimes, out
sourcing partners are required.
With the trend in outsourcing growing very fast , many
suppliers now have entire divisions dedicated to
providing these services to their OEM clients.
While looking at this type of outsourcing, medical
product manufacturers should first decide what they
want. Device companies often use such services because
they are seeking an unbiased opinion from a third
party.
Such services go beyond traditional customer service
functions. For medical component manufacturers
customer service is typically associated with minor
modifications to an existing product configuration.
When the supplier acts as consultant, the service
helps a company assess a project, identify objectives,
and achieve its goals.
Material Selection and Extrusion
Critical application of medical devices which includes
smaller size of the catheters requires them to be made
of much tougher materials than their larger
counterparts. Often Teflon, FEP, or PFA are used
rather than polyethylene or PVC, to maintain physical
strength in smaller-diameter catheters.
Tooling used to make the small catheters requires
tight tension controls and close tolerance. In order
to maintain product uniformity, temperature
controllers with tight control are also needed, as
well as tight speed controls of the extrusion and
downstream equipment. Variable-frequency drive motors
are now used to provide this increased accuracy for
the extrusion line. And active tension devices are
used to maintain constant tension on the wires and
catheters during extrusion. |
Injection Moulding Services
Medical
Device industry can grow by leveraging the outsourcing
of their medical component requirements. It is
important for them to select a good partner, since
these contract molders will become an extension of
their manufacturing capabilities.
Successful injection moulders have seamlessly
assimilated a scientific approach to international
product realization planning requirements in their
validation, quality, and manufacturing disciplines.
They appreciate that medical device manufacturers need
partners that apply technology and have a team of
expert operators that can advance their systems.
Lean manufacturing, six sigma, a vigilant commitment
to a quality policy, complying with the ISO 13485
standard etc work as the new benchmark.
This
commitment to quality helps a molding partner that has
implemented scientific molding practices and has
procedures to demonstrate it.
Assembly Outsourcing
Assembly of medical
devices is outsourced for various reasons with
following important considerations in mind:
- FDA Requirements
- Proper lot numbering
to maintain traceability.
- Specifications for
tolerances for components and sub-assemblies.
- Flexibility of
assembly designs
- Flexibility of
component sourcing.
- Appropriate
scheduling of deliveries
Packaging
On
average, 20% of pharmaceutical packaging is outsourced
to contract packagers, while nearly 14% of medical
packaging operations are outsourced. So reported
respondents to PMP News's 2006 Healthcare Packaging
Survey.
|
|
Medical Molder
Acquires Contract Manufacturer in India
SMC'S acquisition of an India-based company allows
clients to develop products in the U.S. and have
long-term manufacturing in Asia
SMC Ltd. ( Somerset, WI;
www.smcltd.com ),
a fully integrated designer, precision injection
molder, and contract manufacturer of medical devices,
has acquired Laxmi Electronics, a Bangalore,
India-based manufacturer with similar technologies.
The company will be known as SMC Laxmi Electronics.
"We have been fortunate to achieve significant growth
in the medical markets, and this acquisition brings
many strategic benefits for customers seeking to
develop products in the United States and have
long-term manufacturing in Asia," says Chetan N.
Patel, SMC's president and CEO. "It establishes our
presence in Asia and allows us to participate in the
remarkable growth of India's manufacturing base. This
is an opportunity to provide our customers with the
best of both worlds."
Founded in 1983 as a mold manufacturer, Laxmi
Electronics also has expertise in thermoplastics
technology, and has grown to three facilities totaling
more than 100,000 sq ft. In addition to tooling, the
ISO-certified company now provides precision
injection-molded component manufacturing and contract
manufacturing services to customers in Asia, Europe,
and the United States.
SMC Ltd. is a manufacturer of close-tolerance tooling,
injection-molded plastic parts, and OEM products
primarily for the medical industry. The company
operates three ISO-certified manufacturing facilities
in western Wisconsin and in the Minneapolis/St. Paul
metro area. The firm also operates a fully integrated
electromechanical design and rapid-prototype facility
in Dayton, OH, providing a turnkey resource for
product development.
( Ref:-
http://www.devicelink.com/mpmn/archive/07/03/013.html
) |
