5.4.2010 SPEAKER: Helen Colquhoun, MD, Founder and CEO, Pleiad MODERATOR: Zen Chu, Director of Business Development & Wyss Accelerator Fund, Wyss Institute for Biologically Inspired Engineering, Harvard University

Forum Summary

The major question in the world of biomedical devices is how to produce devices to help patients while simultaneously making money for investors.  Long-term planning should be an essential component of product development because step-by-step development introduces market-related risks that scare away investors.  When thinking about how to win approval for a new product, one must understand the product’s minimum label, or in other words, the most limited claim that the product can make regarding its purpose.  Clinical trials are expensive, and less ambitious claims can sometimes be supported without them.  In the United States, the 510k process can be used to quickly win approval for products claiming to be exactly the same as an existing product, but from a marketing perspective, this process is a double-edged sword.  One possible strategy is to seek regulatory approval through the 510k process and to then conduct a post-market trial to expand the product’s label.  Marketing a device for home use, for example, is one way to expand the label of an approved device.     

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