A-MEDICO Webinar Series: Paradigm Shift in Medical Device Development
Paradigm Shift in Medical Device Development: The Innovation Roadmap™, Fostering Innovation & Optimum Programmatic Direction Under Strategic Regulatory Deployment
The Innovation Roadmap™ is a development approach designed to yield innovation and competitive differentiation while conforming with the FDA-QMSR & ISO-13485.
A properly formatted Innovation Roadmap™ can change a medical device development team’s perception as related to realizing the FDA’s recommendations and prescriptions are structured to yield innovation not inhibit. This is a PARADIGM SHIFT we take a deep dive into within this webinar while exploring the roadmap.
In this A-MEDICO event, MIDI will help you:
· Learn the Innovation Roadmap™ steps for optimized medical device development including Discovery Research™, MVP R&D, AGILE Development and Commercialization under ISO-13485.
· Understand how regulatory controls can be leveraged in the development process to produce a device that is truly innovative.
· Learn how to utilize a development process which results in a device that will be reliable, safe, and effective for its users while infusing competitive differentiation.
· Learn the key engineering/design disciplines and tools deployed to achieve innovation success.
· Review of Case Studies that demonstrate implementation of these innovation principles yielding advanced medical devices.
Speaker:
Christopher Montalbano, CEO, MIDI Medical Device Development
Speaker’s Bio:
Chris is the Co-Founder and Engineering Leader of MIDI. Educated in mechanical engineering at Rensselaer Polytechnic Institute, he graduated with his Engineering Masters and later obtained a Master’s in Business Administration from Hofstra University. While teaching materials engineering, he joined MIDI in 1988 with the pursuit of product excellence, forward thinking and innovation for MIDI’s clients in the medical, life science and home healthcare markets.
He co-pioneered the firm’s Development DNA™ process and methodology and has implemented a comprehensive thorough philosophy involving the research, conceptualization and production implementation of medical and scientific systems while conforming to the FDA QSR & IS0 13485 design control requirements as well as the IEC-60601 risk management for Hazard & Mitigation Analysis. Utilizing DevelopmentDNA™ Chris and the MIDI team develop medical products and systems involving the fusion of design tied to reliable engineering, cost-effective manufacturing design, ergonomics and systems research utilizing the disciplines in harmonious concert.
Chris is a strong vision-orientated leader with a high level of skilled engineering problem-solving mindset in addition to sensitivity toward innovative design. He is the recipient of numerous national design and engineering awards as well as dozens of utility patents. Chris has implemented over 100 successful turnkey medical and life sciences development programs for clientele. He sits on the Board for Stony Brook University’s Center for Biotechnology as related to evaluating new medical and surgical technology candidates for funding via LIBH (Long Island Bioscience Hub). He is an active investing member at Mid Atlantic Bio Angels in New York City.