What are the ‘usual’ distribution options for Europe?
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The advantage for a new device to have a consistent message in its first commercial market place through controlling all sales and training actions with internal personnel has obvious appeal. The advantage of the founders having consistency of their message and controlling all sales, becomes more of a necessity the more complicated the technology is to use. The need for a minimum of four senior directors covering five languages is required to properly cover the European markets with direct hires. The challenge of managing them from abroad is difficult. The current capital markets environment requires a tight head count for start-ups to focus their limited funding on product development, clinical trials, and the anticipated FDA approval and U.S. launch for their device. Although funding for the medical device sector is stronger than for other industries, investment dollars by venture capital firms are being closely managed, and support for adding head count in Europe, in most cases, is not widely blessed. The U.S. medical device start-up rarely is shifting funds to hire a direct sales force to commercialize EMEA after receiving CE Mark. The uncertainty of hiring and managing the right personnel from abroad is magnified in importance because of the critical timing of the commercial launch, the difficult European HR issues to hire/fire, and the limited investor funding being burned from this effort. Overall, a direct sales force tactic for EMEA is the most expensive sales initiative a start-up can implement, without having guarantees for success. Alternatives are:
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