Metabolic sensor pivots from disease tool to lifestyle platform

The story

A diagnostics company had a high-accuracy metabolic sensor cleared for use alongside standard care. The business depended on payer coverage, prior authorizations, and prescriber workflows. Growth stalled. Advocacy groups loved the science. Consumers wanted the feedback loop, not the diagnosis. The leadership team set a new aim: expand beyond disease management into a lifestyle platform while protecting regulatory posture and clinical credibility.

We designed a two-track product and operating model.

Product. We separated regulated Software as a Medical Device from wellness features in the same app. The SaMD track handled measurement, data integrity, and clinician-facing reports under IEC 62304 and ISO 13485 processes with postmarket surveillance and complaint handling. The lifestyle track delivered habit loops: food logging, adaptive goals, training plans, and closed-loop nudges. We created hard separation for claims, risk management, labeling, telemetry, and release trains. Users could move between tracks through an explicit consent gate.

AI and analytics. We deployed an ML pipeline that learned an individual’s glycemic and activity response to meals, sleep debt, and exercise. The wellness engine ran on a feature store with model cards, drift monitors, and human-in-the-loop guardrails. We used a conservative predetermined change control plan for SaMD algorithms and a faster cadence for non-medical personalization. The system generated “next best action” prompts that tied micro-choices to next-day readiness scores and weekly goals. We kept sensitive processing on-device where practical and hashed events upstream to protect identity. Aggregated insights fed product roadmaps and retailer partnerships, not ad targeting.

Go-to-market. We pivoted from Rx-led demand to a consumer subscription with tiered value: Essentials, Performance, and Pro. Essentials bundled sensors and a baseline coaching loop. Performance added periodized training and meal sequencing for athletes and metabolic-health seekers. Pro served clinician-supervised users with exportable summaries and EMR integrations through FHIR. We built channel plays with fitness brands, endurance events, and employer wellness. Partner SKUs included starter kits and twelve-week “metabolic reset” programs with guaranteed milestones. Pricing aligned to hardware costs, sensor wear time, and engagement intensity. We reframed success metrics from prescriptions filled to active days, weekly streaks, and net revenue retention.

Execution. We established a single governance board that owned SaMD risk, data privacy, and ML change control. We codified data partitioning, consent flows, and user messaging to avoid implied medical claims in wellness. The commercial team ran A/B tests on onboarding, prompt cadence, and content length. The supply team solved for continuous sensor availability and return logistics to cap hardware losses. Finance tracked CAC by channel, attachment rate of multi-month plans, and sensor utilization per user-month.

Results in the first year. Total addressable market expanded from specialty-care patients to a consumer segment multiples larger. Subscriptions became the primary revenue line within two quarters. Average revenue per user rose with tier upgrades. Churn fell when we introduced periodized programs and social accountability. Hardware gross margin improved through bundle economics and lower return rates. The regulated product kept clean audit findings. The brand now stands for actionable lifestyle insights backed by clinical rigor, not reimbursement friction.