This month MIDI Principal, Chris Montalbano, was invited to PITTCON 2020 as a Guest Speaker in Chicago. Chris presented “Embracing Regulatory/Design Control Constraints as a Viable Innovation/Development Strategy“. The presentation encompassed the preparation necessary for a new medical design for market readiness and to achieve 510(k) success. Chris discussed that the product development process deployed needs to incorporate medical regulatory and design control requirements. While this approach is often viewed as a “means to an end,” Chris revealed the true design innovation potential that results from the proper structuring and application of control methodologies within a unique systems approach. A case study was presented tied to MIDI’s unique Systems Approach/Methodology to inspire and encourage participation. In the case study, a direct correlation was revealed between the regulatory/design control methodology and innovation outputs in areas, such as but not limited to:

− Market Augmentation (unmet needs)
− Technology Enhancement
− Usage Ceremony & HMI Advancement
− DFX (DFM & DFA, cost competitiveness)
− IP Generation (market protection)