In June of 2018, ViaTechMD engaged DuVal & Associates to assist in FDA negotiations and development of a risk and mitigation analysis and clinical trial design as requested by the FDA. DuVal & Associates was formed in 2004 with a mission to focus on serving companies with unique needs that are regulated by the FDA, leveraging the firm’s exceptional industry experience, practicality, and responsiveness. The firm brings pragmatism and unapologetic advocacy. Its President and CEO, Mark DuVal, spent 17 years in-house between 3M Pharmaceuticals, 3M Medical Devices, and Medtronic. As a general counsel, he used to hire regulatory and compliance counsel from the big law firms in Washington, D.C. and felt they were often impractical, too expensive and less responsive to the exigencies of business, and did not deliver the results he needed. He often felt short-changed by these firms. They were afraid to advocate hard for clients because they are always fearful of not remaining friendly with the Agency. In contrast, DuVal & Associates believes a lawyer can advocate aggressively, yet diplomatically and with respect, and obtain better results for clients while maintaining the firm’s and the client’s positive relationship with the FDA. DuVal & Associates has been doing that for years, and understands that a firm should serve with distinction as a strategic partner and trusted advisor with real world insight gained from industry experience.