Abstract
In many FDA-regulated companies, the marketing and business development departments have a quietly antagonistic relationship with their quality and regulatory affairs colleagues. While compliance is supposed to ensure that a safe, efficacious and high-quality new product reaches the marketplace, marketing and business development executives are left to grumble: how are consumers – much less partners and investors – supposed to learn about and get excited about a new product if their work is so constricted? This paper suggests that there is a way to turn compliance from the millstone around Marketing's neck to the whetstone that helps hone a sharper competitive edge. HydroGel Burn Products tackled that question by shifting quality and regulatory affairs further upstream in their product development process to a point where to be overly restrictive was to stop development altogether; in other words, to a point where the focus had to be on finding a way around obstacles. The results pleased investors, partners, customers and marketers alike.
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