Architecting the Future of Medical Technology: From Concept to Global Commercial­ization.

01

Enterprise R&D Execution & Global Capital Deployment

Executive Mandate

Commands full P&L, IP generation, clinical validation, and cross-continental operations spanning multiple continents as Global Head of Product Development and NIH Principal Investigator.

Impact

Authored, defended, and secured over $12M+ in non-dilutive federal capital across NIH/NIA, NIH/NINDS, and NIH/NIDA awards. Architected internal lifecycle design cycles and rapid-prototyping infrastructure that slashed external development dependency by 80%, reduced enterprise development costs by 75%, and accelerated iteration cycles by 3x to scale 8 integrated commercial platforms.

02

Full-Stack Medical Device Lifecycle (Class I, II, III & SaMD)

Executive Mandate

Serves as the global enterprise architect and final technical authority orchestrating the convergence of electromechanical hardware, embedded firmware, edge artificial intelligence, and scalable cloud data architectures. Commands the seamless integration of these complex digital and physical ecosystems under the most stringent international regulatory frameworks to ensure clinical efficacy, data security, and worldwide market viability.

Impact

• Global Regulatory Stewardship & Standards Mastery: Directed the end-to-end execution of FDA Design Controls (21 CFR Part 820), ISO 13485 (Quality Management), ISO 14971 (Risk Management), and IEC 62304 (Medical Device Software Lifecycles) across a vast portfolio of Class I, II, and III medical devices and combination products (21 CFR Part 4). Expertly navigates complex international compliance ecosystems, driving global market access through FDA 510(k) and Breakthrough Device Designations, European CE Marking, CDSCO licensing, IEC 60601 electrical safety standards, and rigorous NIST cybersecurity frameworks.
• Enterprise IoMT & Interoperability: Orchestrated clinical-grade Internet of Medical Things (IoMT) and Software as a Medical Device (SaMD) platforms engineered to securely ingest high-frequency biometric streams into AWS IoT cloud infrastructures. Fused edge-based machine learning classifiers with robust global data privacy protocols (HIPAA, GDPR, CCPA) and seamless, bidirectional HL7/FHIR interoperability with Electronic Health Records (EHR) systems.
• Global CDMO Governance & Commercial Scale: Architected and scaled international manufacturing operations by directing cross-functional alliances with multi-site Contract Development and Manufacturing Organizations (CDMOs) and Clinical Research Organizations (CROs). Successfully transitioned complex early-stage R&D prototypes into globally deployable, submission-ready assets, ensuring rigorous verification, validation, and design for manufacturability (DFM) for high-volume commercial production.

03

Translational Bio-Instrumentation & Connected Health Ecosystems

Executive Mandate

Orchestrates the commercial translation of multi-modal biometrics and complex neurophysiology into scalable, non-invasive diagnostic, therapeutic, and remote monitoring platforms. Bridges critical embedded hardware constraints, including micro-compute, advanced sensor fusion, and power optimization, with secure IoMT cloud architectures to deploy highly versatile, patient-centric clinical ecosystems.

Impact

• Multi-Modal Biosensing & Wearable Architecture: Architected a diverse, clinical-grade portfolio of continuous health-sensing systems, successfully integrating advanced optoelectronics (AI-driven pupillometry), high-density neuro-biopotential signal chains (EEG, subvocal EMG), and continuous physiological telemetry (SpO2, PPG, GSR) across multiple device form factors.
• Edge AI & Connected Health (RPM): Engineered end-to-end Remote Patient Monitoring (RPM) infrastructures, seamlessly linking Bluetooth (BLE) medical wearables with HIPAA-compliant AWS IoT Core data pipelines, edge-based machine learning classifiers, and bidirectional HL7/FHIR EHR interoperability.
• Cross-Platform Electromechanical Scale: Directed the 0-to-1 engineering lifecycle across a vast spectrum of medical devices, transitioning high-complexity concepts, ranging from closed-loop neuromodulation delivery systems and cognitive diagnostic platforms to digital therapeutics (DTx) and combination products, into commercially viable, regulatory-aligned enterprise assets.