the rise of global supply chain competition, along with the projected
annual growth rate of 8-10% in the worldwide medical device industry
market, U.S. medical device manufacturers must continue their course of
innovation. Best practices, though crystallized, must constantly be
reevaluated and revised where appropriate.
With literally hundreds of suppliers across the United States capable of
producing spinal and TJR instrumentation, competition for lucrative OEM
contracts is fierce. Implant success depends on a number of factors -
among which are the size, depth, and position of the hole in the bone.
So how can you make sure that your broaches and reamers will perform to an exceptional standard?
FORM before FIT
tool quality is critical and can depend on accuracy and truth-to-form
of only a few thousandths of an inch. Nonstandard or unanticipated wear
patterns can have catastrophic consequences. You as a manufacturer
deserve the peace of mind of knowing the full geometry of your tooling –
and not merely a few key dimensions.
Gain the Confidence of the Entire Geometry
suppliers have demonstrated a great willingness to apply inspection
methods based on geometric form, and some are beginning to pull ahead of
American manufacturers. Why risk losing the best supplier contracts to
other manufacturers by taking a trial-and-error approach to tooling
A Call to Action
the precarious situation in which the medical device industry finds
itself - opportunity in exploding overseas markets coupled with threats
from overseas competitors - there's never been a more critical time to
reexamine cherished misconceptions about what constitutes a reasonable
standard of speed and quality in tooling development. First movers will
dominate share in their product category - perhaps permanently. Let's
work together that they may continue to be fellow Americans.