While the disruptions of the COVID-19 pandemic may be behind us, there are lessons to be learned about the medical device development supply chain. New pressures, particularly those associated with globally imposed tariffs, have further strained sourcing, manufacturing, and delivery systems for medical device companies. Today, material shortages, price volatility, and supplier unpredictability are persistent realities. To achieve success in this environment, proactive, design-led strategies are no longer optional; they’re essential.

At MIDI, our goal is to help clients bring their medical devices to market with minimal development delays. That’s why our proprietary DevelopmentDNA™ approach includes a robust Design for Excellence (DFX) methodology in which the “X” includes “M” for manufacturing and “A” for assembly. Rather than waiting until a product concept is finalized to address production concerns, we integrate these considerations early and carry them through the entire development process. This leads to:

• Shorter development timelines
• Lower development costs
• Smoother transitions into production
• Improved device quality
• Reduced supply chain risk

But how can this be done while maintaining compliance with regulatory requirements? And how does this align with an ISO 13485-compliant Quality Management System (QMS)? The answer lies in Concurrent Engineering.

To properly operationalize DFX, development activities must happen concurrently, not sequentially. At MIDI, we deploy this Concurrent Engineering approach with two key principles:

1. Considering the device’s full lifecycle early in the design process, including the deployment of DFX strategies
2. Performing all design activities in parallel rather than waiting for a traditional, stepwise sign-off process
   

Although this approach may seem incompatible with the FDA’s rigorous regulatory expectations, it’s not only supported but also encouraged. The FDA’s Design Control Guidance initially outlines a Waterfall Design approach. Still, it goes on to recognize the advantages of iterative, concurrent engineering, especially when it includes real-time QC feedback loops. While this model requires more rigorous review, documentation, and verification, it is fully viable when integrated into a compliant Quality Management System (QMS).

Within MIDI’s DevelopmentDNA™, our INNOVATION ROADMAP™ serves as the procedural framework for executing this approach. MIDI’s production realization SOP, defines step-by-step processes and visual maps for implementing concurrent engineering in a fully ISO 13485, AGILE environment. It’s a proven path to getting products to market efficiently, without sacrificing safety, quality, or compliance.

As today’s global market continues to shift, MIDI’s Advanced DFX Strategy helps clients future-proof development and reduce vulnerabilities, whether from tariffs, supplier disruptions, or shifting component availability.

 To learn more, listen to our podcast series: Designing Through Disruption – Advanced DFX Strategy & Supply Chain Paradigm Shift for Medical Device Development, available now in the MIDI Innovation Vault™.