Until then, companies will have to rely on customized solutions that already exist, such as nanomolding and specialty resins
that convert metal components into plastic.
Nanomolded parts usually are measured in cubic millimeters.
One company, Medical Murray Inc. of North Barrington, Ill., is already designing such microscopic parts. The firm has a nanomolding machine called the Sesame that can hold low volumes of
melted material and offers controlled high speed and high pressure injection capabilities. The machine, according to company literature, can make submicromolded-size parts with complex
geometric features from materials such as bioabsorbable polymers
that would disintegrate in standard equipment. The Sesame can
be used to make insert-molded devices that require tiny, integrated features for such applications as overmolded polymers,
electronics, and radiopaque markers.
Other Priorities: Turnaround Times,
Many of the outside influences currently affecting molders have remained unchanged over the last few years: cost pressures, time to
market, quality management and federal regulatory requirements.
“Many medical customers are outsourcing due to cost pres-
sures,” said William Tang, general manager at Meiban Micro Pte
Ltd., a Singapore-based company that specializes in precision and
medical molds as well as molding.“This is supported by the trend
that medical molding is gradually gaining a lot of ground in Asia
where cost is generally much lower than that in the United States
and Europe. Another trend that we see is the pressure on time to
market. This is traditionally not such a big concern in the medical
device industry. However, in certain segments, competition is get-
ting tough and customers require very good turnaround in proto-
type tooling as well as production tooling to shorten the time to
market. This is where molding companies must be willing to in-
vest in time and resources to work with customers on product de-
velopment programs. They should also develop competencies to
be able to add value in the product development phase.”
While compliance with U.S. Food and Drug Administration
(FDA) regulations always is a concern for molding companies, the
agency’s recent focus on supplier quality and the device approval
process has prompted many OEMs to look at their outsourcing
partners with a more critical eye.