Live tumor cell processing for personalized cancer treatment

We began by observing pathology and radiology workflows to map out specimen handling, personnel interactions, and environmental constraints. From that research they designed a fully integrated instrument plus a preloaded disposable cartridge, minimizing onboard fluidics and waste. Wireframes and early UI prototypes were tested with end users to ensure clarity and safety. Industrial design refined ergonomics, material selection, and system balancing. Mechanical engineering and systems design addressed manufacturing, disposables, and regulatory needs. Human factors studies and formative verification data were compiled into design history and FDA de novo submission documentation.