>Look at FDA clearance for instance - if you introduce a new product category
>it will cost of a lot of money. Then when you've gone through the hard work
>your competitors can leap on the bandwagon and get FDA clearance for a
>fraction of the cost simply by showing that their products are similar to
>yours.
This is indubitably true for "devices" and a reason why patent protection
is so sought after for medical device innovations. Yet, even without
patent protection, "first to market" can be very dominant for many
years. Look at NellCor pulse oximeters. There are better devices out
there, but NellCor still has well over 50% of the market.
>That process also forms a big barrier to open-source software.
I am not at all clear about this point, Eliot. What are you basing this
statement on? The FDA simply doesn't regulate record keeping software at
this time. In addition, their software reg's, which I have examined rather
carefully, seem to encourage open source. They want a specification, but
they also want mechanisms for discovering "bugs", read open source.
I would also say that something like the MDSchedule project on SourceForge,
which I simply do not have the time to pursue, is *absolutely perfect* for
open source: no hint of the FDA, no competition at the open source price
point ($0), and desperate need.
John
