In this episode, MIDI CEO Christopher Montalbano outlines how MIDI adapted to the rapidly shifting supply chain environment during the COVID Era and how these same methods assist in derisking during the Tariff Era.

Chris introduces MIDI’s Advanced Design for Supply Chain (DFSC) Strategies, developed under their broader DFX (Design for Excellence) framework and implemented through their ISO 13485 QMS and agile development methodology. These strategies aim to reduce risk and ensure product availability in uncertain markets.

Key approaches covered include:

Shifting from traditional Just-in-Time (JIT) models to hybrid inventory strategies like the “sell-one-stock-one” approach.

Expanding supplier redundancy—moving from dual sourcing to tertiary and quaternary sourcing with geographic diversity.

Incorporating independent distributors to fill gaps in component availability, supported by procurement intelligence tools and rigorous quality screening.

The episode also features Pat Farrell of Advanced Assembly, who shares recommendations for managing printed circuit board (PCB) production within this new supply chain paradigm.

Together, Chris and Pat emphasize the importance of tight coordination between engineering, manufacturing, and supply chain teams from day one of development to proactively mitigate production risk and maintain project timelines in an unpredictable global landscape.

In Episode 2, Chris Montalbano, CEO of MIDI Product Development, takes a closer look at DFX, Design for Excellence, and what it really means when applied to medical device development, especially when derisking is required in the face of global uncertainty (tariffs).
Chris breaks down how DFX goes beyond just cost and manufacturing. It’s about designing for every critical factor: Manufacture, Assembly, Testability, Usability, Service, and Reliability. When DFX is applied early, it leads to smarter product decisions, faster development timelines, fewer late-stage issues, and better long-term business outcomes.
If you're developing a medical device, this episode offers practical insight into designing for success from the start and a way to derisk in this globally strained supply chain environment.

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.