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.