Solving for X on the Innovation Roadmap™ : Advanced DFX Strategy in MedTech

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Most often referred to as DFX, “Design for Excellence” is a tool used across disciplines in development and engineering to identify and formally address factors intimately related to a product’s specific features when considering the entirety of the product’s life cycle. As shown by the term’s variant “Design for X,” “excellence” in this case is not a value or standard but a variable to be defined case-by-case. 

While DFX strategies may be applied at any stage of development, their focus on risk mitigation means that their success is increased exponentially when implemented early on, with specific advantages including shorter development timelines with faster go-to-market; reduced development costs; improved financial performance with comprehensive cost management; streamlined transitions when entering production; reduced supply chain risk; and higher device quality.

In the world of medical devices, efficacy, cost, and safety are the primary concerns in any development effort; at MIDI, DFX is deployed as a means of ensuring that they are prioritized both early in the design and throughout, defining “x” by a small list of factors for which all designs must be optimized, including:

Here, we’ll take a look at these components of DFX, how they can be preemptively addressed, and why one should look to do so.

Design for Manufacture (DFM) and Design for Assembly (DFA)

Design for Cost Optimization

Design for Testability (DFT) and Design for Usability (DFU)

Design for Service (DFS)

Design for Reliability (DFR)

DFX is far more involved than the simple acronym would suggest, and executing its strategies effectively is no small task. For development teams, here are some practices that can help to ensure success:

  1. Build DFX activities into development plans and SOPs to ensure continual focus.
  2. Track DFX checklists for functional areas, including manufacturing, assembly, cost, testing (both verification and validation), procurement, service, and reliability.
  3. Institute a cross-functional team with representative experts in each “X” variable at the beginning of development.
  4. Test and review designs early and often, requiring DFX objectives within all project and technical review criteria. 
  5. Develop an intentional plan for scaling with a keen understanding of your target production volume; executing this will be critical to effective design transfer into production. 

Advanced DFX strategy is not just a means of ensuring safety or reducing costs but a tool that allows developers to gear design towards a specific product, project, and business objectives, something truly invaluable in times of change and instability.

Design for Supply Chain (DFSC) has been excluded from this overview; with global events as they are, the need to precisely and carefully address matters of supply during the development process is more significant than ever, and our strategy has grown to match. Keep an eye out for our next blog, which will cover how and why DFSC is attended to during a device’s journey on the INNOVATION ROADMAP™.

To find more information on the other Xs in our definition of DFX, visit the MIDI Innovation Vault

To hear more about Advanced DFX Strategy at MIDI, check out our new MIDI Innovation Vault™ podcast series: Advanced DFX Strategy & Supply Chain Paradigm Shift for Medical Device Development.

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