This month MIDI Principal, Chris Montalbano, was invited as a Guest Speaker to the BIOMEDevice Show in Boston.  Chris presented “Case Study: Product Innovation While Embracing Regulatory Control as a Viable Development Strategy“. The presentation encompassed the product development preparation necessary for a new medical design to successfully achieve market readiness (i.e. 510k) via design controls, while simultaneously innovating utilizing a stepped DevelomentDNA^TM methodology.  While the regulated design control process is often viewed as a “means to an end,” the presentation revealed the true design innovation potential that results from the proper structuring and application of control methodologies within a unique DevelopmentDNA^TM systems approach. The case study directly correlates this systems-approach strategy which embraces the regulatory process revealing output yielding competitive differentiation.