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The first sale is initiates the release to the public domain.
5) Regulatory Issues- but the developing world has very very few RI.
- still need the 801 but need the 510K if sold in US.
6) Standards issues (ISO and AAMI), often 90% of your costs go only to safety and not to treating patients. So you need to raise money for standards.
7) If X already exits why not give it away- you could just run a refurb business.
Model 3- Sell my X to emerging markets and give X to the developing world
- Dr. Malkin not sure of any one that has been succesfull with this
1-7) Just like model 2, minus the fact that regs and standards might be lower
-Pay attention to import taxes, etc...
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