We assessed and validated our business model through research with internal resources and outreach to major stakeholders in the future of our product. These included clinical research organisations, certification and regulation experts, and a cancer research and treatment institute to host our clinical trial. We assessed the market and forces driving growth in cancer research, concluding that not only is there significant business opportunity for us, but a major opportunity to improve clinical cancer care throughout Europe - this will have critical impacts on future EU health objectives, as Europe, despite having only ~12.5% of the world's population, carries about 25% of the world's cancer burden.