When Kevin Liu, a Minnesota-based Chinese entrepreneur, decided that he wanted to test his disposable medical device, he thought that going to China was a no-brainer.
Experience proved otherwise. Liu had intended to file a 510(k) application by the end of last year with a launch in May. Instead, he had to contend with repeated delays and finally submitted an application in March.
“What happened is that like many companies, to cut costs I thought to test products in China because it’s a fraction of what it costs to test here,” Liu said. “But I had a tough time. We picked a reputable testing center in China, but still we had communication issues back and forth, wording corrections, things that were wrong that we had to fix over and over. That made everything so much slower.”
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Then Liu ran into the Chinese New Year, the big annual celebration in which the nation of more than 1.3 billion shuts down for the better part of a month.
Finally, in March, Liu through his company United Medical Innovations submitted 510(k) applications for its syringe and manifold kit system. He now expects a launch in the fall.
“I am from China, so I always thought it would be easier because of my cultural background and my language — to communicate with them directly — but experience tells me that it is not as easy,” he said. “There are difference business styles and there is a real trust issue with business men in China. You are thinking of how are you going to protect your intellectual property. There are so many things to think about. That is something I learned from this experience.”
[Photo Credit: Ohmega1982]
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