Healthcare Product · Regulatory Systems

I find the
clinical gap.
Then I close it.

Product manager with domain expertise in neonatal monitoring and medical device regulatory. I don't just spec products — I build the clinical pipelines, the consumer apps, and the compliance infrastructure to ship them.

Domain
Neonatal pulse oximetry — alarm fatigue, GA-adjusted baselines, NICU-to-home transition
Scope
Clinical data pipeline (HL7v2, EHR integration) → Consumer monitoring app (React Native) → Regulatory OS (IEC 62304, ISO 14971)
Technical credibility
Specs production code, ships it, reviews it against regulatory standards
5
Specialist reviewers built
6
Standards referenced
21
Regulatory skills
20/20
Fixture validation pass
01
Neonatal Monitoring

380,000 preterm infants go home each year with no personalized monitoring.

Providers discharge infants with BPD and CHD using fixed SpO2 thresholds that don't account for gestational age. A 90% alarm on a 34-week preemie fires constantly — creating alarm fatigue that masks real desaturation events. Parents get raw numbers with zero clinical context.

Insight
Baselines must be personalized. Preterm SpO2 ranges (92–95%) overlap with term "borderline" values (97–100%). GA-adjusted p5–p95 bands validated against Castillo 2008 and Dawson 2010 cut false alarms without missing true hypoxic events. Clinically significant desaturation requires both depth and duration — not just threshold crossing.
What I Built
SpO2 Pipeline: Rule engine → ML classifier → LLM-as-judge evaluation. HL7v2 interop, EHR-ready triage flags.

Babysat: React Native home-monitoring app. 14-day rolling baselines, AI narratives via Claude API, BISQ-R sleep assessment, provider handoff reports with tokenized viewer.
SpO2 Pipeline → Babysat →
02
Regulatory Infrastructure

SaMD teams can't ship because their regulatory artifacts are disconnected from their codebase.

Design controls live in spreadsheets. Risk files reference code that's already changed. Every 510(k) submission is a manual reconciliation exercise. Teams that shipped first have zero traceability between their code and the regulatory artifacts they need to produce.

Product Judgment
Built SaMD-OS — a regulatory operating system that generates IEC 62304 artifacts from the codebase and reviews them with specialist agents. Three reverse-engineering skills for teams that shipped before documentation: Code → SOUP Register, Code → Design Inputs, Code → Hazard Candidates.
Standards
IEC 62304:2006+A1:2015 — Software lifecycle ISO 14971:2019 — Risk management ISO 13485:2016 — Quality systems IEC 62366-1:2015+A1:2020 — Usability IEC 81001-5-1:2021 — Cybersecurity FDA Premarket Cyber (2025)
Regulatory Reviewer
Catches submission gaps, flags incomplete intended use, predicate issues, SOUP register holes
QA Auditor
ISO 13485 compliance — CAPA records, complaint trending, document control
Safety Engineer
Foreseeable misuse, hazard chain completeness, AI/ML automation trust
Cybersecurity Analyst
SBOM validation, threat modeling per AAMI TIR57, Section 524B
Clinical Reviewer — Neonatal SpO2
Domain specialist modeled on published literature (Bonafide et al., AAP consensus). Reviews SpO2 logic, alarm management, triage accuracy, nurse handoff quality.
SaMD-OS case study →
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