A medtech client partnered with ALTEN Technology to drive the commercialization and design for manufacturability (DFM) of a novel coagulation device, targeting a $1.8 million market opportunity. The project’s strategy centered on ensuring the manufacturability of the system’s consumable component, integrating an updated design into an automated alpha meter, and thoroughly reviewing the current laboratory alpha meter design to identify and address gaps related to medical device 510(k) submission requirements. Crucially, design controls were introduced early in anticipation of the regulatory submission process. Leveraging their comprehensive expertise across mechanical, electrical, systems, software, project management, and quality assurance, ALTEN Technology successfully proved the feasibility, manufacturability, and business case of the consumable within a swift three-month period. This critical achievement helped the client secure final funding necessary for the full meter development. The team further developed full system and subsystem requirements for a beta meter, maintaining consistency and efficiency throughout the subsequent development phases. Advanced tools and technologies such as Altium, Mathematica, Orcanos, Cameo, FIGMA, SolidWorks, and Flutter were instrumental, alongside conducting a feasibility study on the Toradex processor to support meter functionality.