Success in Academic Surgery: Innovation and Entrepreneurship Managing FDA Regulatory Requirements into a Positive Bridge for Commercial Success

Many surgeon entrepreneurs have the conviction that their innovation will successfully enter the market and for the general measurable good of all. But there are many barriers that make successful entry into the US market with a medical innovation difficult. Moving an innovation from concept to point of care is frequently challenged by a lack of resources and money, a clearly defined market need, reimbursement issues, manufacturability issues, and successfully addressing the basic question “Is there a real business here and for who?” This chapter provides an overview of the regulatory and commercialization pathways that devices are required to follow in order to gain FDA approval and gain entry into the market. Creating a thoughtful regulatory roadmap with a process in place to complete each step along the path will save a company both time, money, and in many cases frustration related to getting their product to market. While the FDA has many rules and regulations to keep the consumer safe while using new technologies, they are an important group to engage and work with through this often complex process.