Ep 1 Series 13 | Value of Concurrent Engineering with Inclusion of DFX in MedDevice, Operationalized under ISO-13485
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In this kickoff episode of Designing Through Disruption, Christopher Montalbano, CEO of MIDI Medical Product Development, explores how medical device teams can integrate a resilient, forward-thinking approach into their product development strategies, especially in the face of global uncertainty (tariffs).
Chris introduces listeners to MIDI’s DevelopmentDNA™ process and explains how their firm has evolved to embed advanced Design for Excellence (DFX) strategies early in the development cycle. These methods, initially honed during the COVID-era supply chain crisis, are now proving indispensable as global tariffs and component shortages continue to challenge the industry.
Key takeaways from this episode include:
What DFX really means—and why it should never be an afterthought
The strategic advantage of Concurrent Engineering over traditional development models
How to align advanced development methodologies with ISO-13485 and FDA design control guidance
The role of MIDI’s Innovation Roadmap™ in mitigating risk and accelerating time to market
This episode lays the foundation for a series focused on strengthening medical device development pipelines, making them compliant and competitively agile.
Next, we’ll explore the supply chain conundrum further and share our Advanced DFX Strategy for design-for-supply-chain integration.