Medical Device companies commercializing innovative technology experience challenges balancing the need for continuous improvement and the constraints of the regulatory environment. Traditional focus on a compliance first approach does not address many of the critical elements that affect product quality and promote safe and effective medical devices. The MDDA Pilot provides companies the opportunity to participate in an alternate approach to compliance using the CMMI as the baseline for assessment. Edwards Lifesciences experience found the CMMI was less expensive and disruptive to business activities, provided actionable feedback for improvement, and integrated well with other feedback and planning inputs.