The Innovation Roadmap™ for Medical Device Development: Fostering Innovation & Optimum Programmatic Direction Under Strategic Regulatory Deployment

Christopher Montalbano
CEO, MIDI Product Development Corp.
As Co‐founder and engineering leader of MIDI, Chris joined MIDI in 1988 and for over 30 years has been committed to developing medical devices for clientele with advanced engineering, possessing optimized user design and cost effectiveness. He copioneered the firm’s DevelopmentDNA™ quality process and systems approach/Methodology, implementing a comprehensive thorough philosophy involving the fusion of design tied to reliable engineering, cost effective manufacturing design and advanced HMI utilizing these disciplines in harmonious concert. This quality process conforms with the FDA‐QSR & ISO‐13485 requirements yielding commercializable solutions, facilitating designs which can achieve FDA 510k tied to innovation and competitive differentiation. Chris’ strong vision‐oriented leadership provides a high level of skilled engineering problem‐solving methodologies with sensitivity to innovation design. He is a recipient of numerous national design and engineering awards along with dozens of utility patents. Chris was formally educated in Mechanical Engineering at Rensselaer Polytechnic Institute; and later obtained a Master’s in Business Administration from Hofstra University.

Barry Sands
President & Founder, RQMIS Inc.
Barry is a biomedical engineer (with a chemical engineering concentration) with MBA having 35 years experience in regulatory/clinical/quality affairs for medical device/biotech companies. Seven years experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE and FDA’s Boston District. This government experience was followed with seventeen (17) years in midlevel and executive management positions in small start-up and large multinational medical device companies. Market responsibilities included United States (including Puerto Rico), European Union, South America, Canada, Japan and South Korea. For the past 12 years, he has been leading RQMIS in assisting their clients in gaining market clearance in the US/EU/Canada/Brazil/etc. for their combination products (device/drug), medical devices, in-vitro diagnostics and dietary supplements.

Experience includes regulatory submissions (510k, IDE, PMA, HUD/HDE, Design Dossiers), Clinical Study Design/Management, Risk Management, Quality System Design/Audits (FDA QSR and ISO 13485) and FDA Negotiation and Communication (QSR Audits, 483s, Warning Letters, Bioresearch Monitoring, Medical Device Reports, Recalls).