Currently, GMD occupies an industry of one, but there is plenty of room for other generic manufacturers. Ideally, each new generic manufacturer would focus on a unique device segment in order to best meet increasing demand and maintain the highest levels of safety and efficacy.
They take on existing devices which are available, have been approved for 510(k) clearance, and then sell them at 2/3 the cost of branded counterparts. What's unclear to me from the article is what their patent position is. Has no one really done this before, or does the pace of surgery go so fast that surgical instruments that were in use 20 years ago ( e.g. screws) are abandoned by the companies that developed them?
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