orthopedic giant. Like most orthopedic companies, DePuy determined that
designing a MoM hip was imperative. While the FDA did not approve the
Birmingham hip until 2006, it seemed inevitable that every company
would be distributing poly-free hips in short order.
The initial step in manufacturing any implant is the assemblage of a
team of engineers, designers, market experts, and consultant surgeons. A
design team gathers on a regular basis over the course of a few years, but
initially must analyze market needs, existing products, and the “freedom
to operate” regarding existing patent laws in the United States and
internationally. The “intellectual property” (IP) that a company owns
(once a patent has been granted) establishes a barrier of imitation that is
supposed to be obeyed by manufacturers in internationally law-abiding
countries. If a competing company has strong IP surrounding an implant,
the new design team is forced to innovate new styles, shapes, techniques,
and technology, so as not to infringe upon a competitor’s legal rights.
Sometimes the alterations in design offer an improvement in performance
(while creating a “work-around” in the barely legal, imitation game), but
occasionally the modification creates serious crises.
While implant companies typically employ “in-house” engineers and
market experts, the surgeons on a design team are independent physicians
who are consulted for their expertise in the field. Typically, design
surgeons are university-bound, academic surgeons, practicing at the
pinnacle of their profession, training young surgeons, and instructing at
meetings (often about implants they have designed). Understandably,
companies engage “thought leaders” who not only use a great deal of the
product themselves, but can influence other surgeons as well to become
high-volume users. Almost without exception, surgeons—like physicians
who are involved in drug trials, and scientists who hypothesize and
experiment in scholastic and commercial settings—practice ethically and
without compromise. But the payoff for surgeons who are fortunate
enough to be a member of a successful design team is so huge that one’s
ethical standards can be severely tested.
DePuy assembled a team of surgeons from Australia, Ireland, England,
Germany, and the United States, initially meeting at the turn of the
millennium. Derek McMinn’s original MoM hip had debuted in 1991, and
the successor Birmingham Hip was implanted as early as 1997, and the
incentive to get the next major MoM hip onto the market as rapidly, and
marcin
(Marcin)
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