Bringing Medical Device to Market: Concerns for Startups

30 November 2011 by Light Fabrications

The basic 510(K) process can be overwhelming, especially for higher class medical devices. The multiple successive phases (or gates) that a medical device must satisfy en-route to the market are burdensome and call for a level of expertise that startups lack in most cases. Secondly, lengthened supply chains due to global outsourcing (or globalization) present a causal effect on intellectual property protection. These are legitimate concerns for startups. However, the good news is that organizations such as Light Fabrications are positioned to guide startups through this tumultuous maze.

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