As the COVID-19 pandemic’s third year progresses, our world is finally showing signs of recuperation. Cases are dwindling, precautions are lifting, and businesses are at least finding normalcy in their operations. Yet, the scars left on some industries are nowhere near fading; as one of COVID’s victims, the global supply chain has yet to recover fully from the setbacks experienced these past two years, and circumstances worldwide currently serve only to stall the process further. For medical device companies, this means that complications like material shortages are no longer potentialities but realities that must be addressed early and thoroughly if one is to achieve success in the market.
At MIDI, our goal is to help clients bring their medical devices to market with as few delays in development as possible; for this reason, our proprietary DevelopmentDNA™ approach includes a Design for Excellence (DFX) methodology in which “X” stands for “M” in DFM (manufacturing) and “A” in DFA (assembly). This means that, rather than putting off production concerns until a device concept has already solidified as most do, we address them early on and take steps to accommodate them throughout development, ultimately producing several advantages, including:
- Shorter development timelines
- Lower development costs
- Smoother transitions into production
- Improved device quality
- Reduced supply chain risk
But how do we achieve this while continuing to operate according to regulatory standards? How can this be adequately integrated into an ISO-13485 compliant Quality Management System (QMS)? The answer lies in concurrent engineering.
To appropriately “operationalize” DFX as we do, one must utilize an approach that allows for concurrent development or, more simply, allows for various development activities to take place alongside each other, rather than a conventional engineering approach that operates more sequentially (i.e, Waterfall Design Process). We at MIDI employ this Concurrent Engineering approach with two principles at its core:
- Considering a device’s entire cycle early in the design process, which includes deployment of DFX.
- Performing all design activities simultaneously rather than consecutively. DFX is one of those key activities.
While this approach might, at first glance, appear incompatible with the stringent FDA guidelines we as developers are subjected to, one might be surprised to find that regulatory agencies recognize it as superior to its conventional counterparts. While the FDA’s Design Control Guidance for Medical Device Development uses the Waterfall Design approach to initially describe the proper application of design controls, they acknowledge the validity of concurrent engineering, particularly lauding the benefits of the iterative design process with QC feedback loops. While they are deliberate in noting that this model requires a far more complex system of reviews, approvals, and verification, it is nonetheless stamped with their approval given proper QMS integration.
Within the MIDI DevelopmentDNA™ approach lies the INNOVATION ROADMAP™, which is our production realization standard operating procedure (SOP) fully detailing, in procedural steps along with block-diagram maps, the proper implementation of the concurrent engineering approach, which we have found to be a proven path to success. The INNOVATION ROADMAP™ is our AGILE development methodology to help clients quickly, efficiently and safely develop their medical devices for market. It’s operationalized under ISO-13485.
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.