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The "Insider" Accelerator Strategy
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About me
As an Antler-backed SaMD Product Leader, I develop regulated digital health solutions for APAC and EU/EEA markets with a focus on clinical safety engineering, AI/ML-enabled diagnostic reliability, and MDR/DiGA-aligned product execution. My work centers on designing systems that support clinical judgement pathways, satisfy regulatory and evidence requirements, and operate dependably within real-world clinical environments.
I have led the architecture, validation, and deployment of digital health platforms across APAC, shaping compliant data operations, interoperability frameworks (EHR/API), and workflow models used in high-volume medical environments. My product decisions are anchored in risk management, traceability controls, regulatory pathways (MDR, DiGA, CE-readiness), and coordinated delivery with clinical, compliance, and engineering partners to maintain consistency and integrity across releases.
I specialize in translating regulatory constraints into structured product directives, ensuring alignment between technical planning, engineering execution, and quality management obligations. This enables teams to deliver audit-ready, performance-driven SaMD solutions that scale across jurisdictions and strengthen decision precision, clinical workflow efficiency, and system capacity.
I build digital health systems engineered for reliability, validated through evidence, and designed to support the standards that modern clinical practice depends on.
- Antler X Abhijayhttps://www.linkedin.com/posts/jedrose_last-week-after-receiving-2500-applications-activity-7162738098982879232-BMZZ?utm_source=share&utm_medium=member_desktop&rcm=ACoAACPKc-IBwArz_ASdb6AY3HBG_W0kuXag9LE