Abstract
This chapter strives to inform the reader about the fundamental requirements to create a viable, sustainable medical device company. The content addresses how to build the infrastructure of a fully operational entity and how to take a basic concept for a new medical device and navigate through the research and development, regulatory, quality, and commercialization steps to deliver the product to the market. Important considerations, including the need to place a value on the company, undergo due diligence, and have a clear path for an exit strategy, are addressed to make the company of interest to investors. Most importantly, the chapter emphasizes the need to focus on aiming for profitability and explores how, once that is achieved, this accomplishment opens the door to complete control of the new entity's destiny
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