Decimal.health addressed the client's request through a dual-track approach. First, we conducted a comprehensive analysis to gauge the commercial potential within various indications, considering both regulated and non-regulated environments. This assessment informed our decision on which product to launch rapidly in the US without regulatory oversight. We also determined the optimal customer segments to target, devised a tailored go-to-market strategy, and outlined the commercial and product development roadmap.

Additionally, we examined the FDA regulatory pathways applicable to potential claims across different indications, factoring in success probabilities, approval timelines, and estimated costs. This analysis led us to recommend pursuing the Breakthrough Device Designation (BDD) pathway for a life-threatening indication. Armed with this insight, we actively supported our client in preparing and submitting the BDD application.