If you snooze, you lose.
As you probably know, good design in total joint replacements depends on
good geometric understanding. Engineering misjudgments of mere microns
can ruin the outcome of a joint replacement - resulting in expensive
recalls, product scrapping, and lost time in product development.
In product manufacturing process development, a trial-and-error approach
to form and function can result in dozens of redundant and ineffective
iterations where one or two well-founded iterations might have been
sufficient. This is all to common in some major American orthopedic
companies.
Foreign competitors throughout precision manufacturing - especially but
not exclusively what we increasingly refer to as “Brand China” - have
proved themselves receptive to new ways of improving part quality, while
still decreasing cost, weight and time to market. As we've seen in
other industries, if foreign manufacturers gain the lead over their
American counterparts, they won't give it back.
And domestically, as Don Urbanowicz explained in his
keynote address
at the OMTEC 2011 trade expo, forthcoming changes in FDA regulatory
policy will increase the “First Mover Advantage” still further.
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