The first FDA-cleared deep-learning device for sleep therapy
Situation
Resmed shipped devices at the right clinical pressure, but the comfort settings that keep patients on therapy long term went untuned. A third of patients quit within a year, each one a multi-thousand-dollar loss in lifetime revenue.
What I did
I made the case to the executive team, secured funding, and set the technical direction: digital twins, pairs of near-identical patients in the historical data, one on tuned settings and one untuned, producing real-world evidence that comfort tuning causes adherence. That evidence cleared FDA review. I ran regulatory, clinical, and commercial in parallel with engineering so the submission and the product moved together instead of in sequence.
The number
Cleared FDA 510(k) as the first deep-learning personalization engine for the therapy, with digital twins in production. Projected $100M+ in revenue.