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Ep 1. Series 2 | Paradigm Perception Shift in Medical Device Development: the INNOVATION ROADMAP™
Episode 1 in our new series, "PARADIGM PERCEPTION SHIFT in Medical Device Development: the INNOVATION ROADMAP™ " is now available.
Listen to this first episode as we prepare for an exploration "Explaining the INNOVATION ROADMAP™: Device Innovation as a Result of Embracing Regulatory Controls: FDA-QSR & ISO-13485" with Co-Owner of MIDI Medical Product Development, Chris Montalbano.
In this episode, Chris outlines what's behind the MIDI expert DevelopmentDNA™ approach. He explains that the common perception in the industry is that the Medical Regulatory Design Controls and Risk management (meaning FDA-QSR & ISO-13485) are often viewed as a mandate, a process that will inhibit production innovation.
The perception shift lies in using the RECOMMENDATIONS (called FDA Guidance), REGULATIONS, Design Controls & Risk Management as a viable medical device development innovation platform given a properly-outlined INNOVATION ROADMAP™, which MIDI calls its DevelopmentDNA™ approach.
Under this approach, MIDI's team of engineers and usability experts tied to their industrial designers have the ability to utilize DevelopmentDNA™’s 'INNOVATION ROADMAP' to address the functional, cost-to-manufacturer, safety and business requirements of what Chris calls 'the golden standard approach', which is paired with the follow-through to execute upon that approach in a rapid, AGILE product development fashion under MIDI's Quality-First umbrella.
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By Christopher MontalbanoEpisode 1 in our new series, "PARADIGM PERCEPTION SHIFT in Medical Device Development: the INNOVATION ROADMAP™ " is now available.
Listen to this first episode as we prepare for an exploration "Explaining the INNOVATION ROADMAP™: Device Innovation as a Result of Embracing Regulatory Controls: FDA-QSR & ISO-13485" with Co-Owner of MIDI Medical Product Development, Chris Montalbano.
In this episode, Chris outlines what's behind the MIDI expert DevelopmentDNA™ approach. He explains that the common perception in the industry is that the Medical Regulatory Design Controls and Risk management (meaning FDA-QSR & ISO-13485) are often viewed as a mandate, a process that will inhibit production innovation.
The perception shift lies in using the RECOMMENDATIONS (called FDA Guidance), REGULATIONS, Design Controls & Risk Management as a viable medical device development innovation platform given a properly-outlined INNOVATION ROADMAP™, which MIDI calls its DevelopmentDNA™ approach.
Under this approach, MIDI's team of engineers and usability experts tied to their industrial designers have the ability to utilize DevelopmentDNA™’s 'INNOVATION ROADMAP' to address the functional, cost-to-manufacturer, safety and business requirements of what Chris calls 'the golden standard approach', which is paired with the follow-through to execute upon that approach in a rapid, AGILE product development fashion under MIDI's Quality-First umbrella.