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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.

Stay informed about MIDI’s expanding capabilities,
new projects and our unique approach

Stay informed about MIDI’s expanding capabilities, new projects and our unique approach

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Our product experts can help bring your
innovation to market

Our product experts can help bring your innovation to market