ABSTRACT:

Here, two academic bioengineers who have taken this commercialization step will share their experiences and thoughts. First, we discuss this topic with Steve Quake at Stanford University. Prof. Quake has pioneered the development of multilayer microvalves as a way to control complex fluid handling at a microscale. He has spun off the technology into Fluidigm, a company cofounded by him. Fluidigm has sold many of these microfluidic chips for the research biology market. Next, we talk with Shu Takayama from the University of Michigan. Prof. Takayama has developed microfluidic methods for reproductive medicine (Figure 2), which are being commercialized by Incept BioSystems, a company he cofounded. A key requirement of a medical device for use in U.S. clinics is to conduct trials for regulatory approval from the Food and Drug Administration (FDA). The company completed its first human trials in 2010.