Roma S.

𝐈 𝐡𝐞𝐥𝐩 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞, 𝐌𝐞𝐝𝐓𝐞𝐜𝐡, 𝐚𝐧𝐝 𝐀𝐈 𝐬𝐭𝐚𝐫𝐭𝐮𝐩𝐬 𝐧𝐚𝐯𝐢𝐠𝐚𝐭𝐞 𝐭𝐡𝐞 𝐭𝐞𝐜𝐡𝐧𝐢𝐜𝐚𝐥 𝐦𝐢𝐥𝐞𝐬𝐭𝐨𝐧𝐞𝐬 𝐰𝐡𝐞𝐫𝐞 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐝 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐨𝐟𝐭𝐞𝐧 𝐬𝐭𝐚𝐥𝐥: 𝐚𝐫𝐜𝐡𝐢𝐭𝐞𝐜𝐭𝐮𝐫𝐞, 𝐇𝐈𝐏𝐀𝐀, 𝐜𝐲𝐛𝐞𝐫𝐬𝐞𝐜𝐮𝐫𝐢𝐭𝐲, 𝐅𝐃𝐀/𝐒𝐚𝐌𝐃 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭, 𝐀𝐈 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧, 𝐚𝐧𝐝 𝐞𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠 𝐞𝐱𝐞𝐜𝐮𝐭𝐢𝐨𝐧. I’m a hands-on fractional CTO and Ph.D. technologist with 20+ years across healthcare R&D, software, AI/ML, and regulated product development. 𝐒𝐞𝐥𝐞𝐜𝐭𝐞𝐝 𝐫𝐞𝐬𝐮𝐥𝐭𝐬: • Designed and validated a healthcare LLM/RAG system using an actor–critic architecture and expert clinical evaluation; published in npj Digital Medicine. • Guided healthcare startups through 𝐇𝐈𝐏𝐀𝐀 𝐫𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬, including AWS architecture, security controls, logging, access management, and operational processes. • Led development of 𝐭𝐰𝐨 𝐅𝐃𝐀 𝟓𝟏𝟎(𝐤)-𝐜𝐥𝐞𝐚𝐫𝐞𝐝 𝐒𝐚𝐌𝐃 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬, including ML-based sleep staging. • Led Class II medical-device development across five product programs and a 25-person engineering, QA, and manufacturing organization. • Built medical-device 𝐜𝐲𝐛𝐞𝐫𝐬𝐞𝐜𝐮𝐫𝐢𝐭𝐲 𝐩𝐫𝐨𝐠𝐫𝐚𝐦𝐬 𝐚𝐧𝐝 𝐅𝐃𝐀 𝐜𝐲𝐛𝐞𝐫𝐬𝐞𝐜𝐮𝐫𝐢𝐭𝐲 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧, including threat modeling, risk management, controls mapping, and verification evidence • Led TytoNyx through AWS Foundational Technical Review (FTR), AWS Partner qualification, and Marketplace commercialization. 𝐖𝐡𝐞𝐫𝐞 𝐈 𝐚𝐝𝐝 𝐭𝐡𝐞 𝐦𝐨𝐬𝐭 𝐯𝐚𝐥𝐮𝐞 𝐅𝐫𝐚𝐜𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐓𝐎 / 𝐓𝐞𝐜𝐡𝐧𝐢𝐜𝐚𝐥 𝐋𝐞𝐚𝐝𝐞𝐫𝐬𝐡𝐢𝐩 — architecture, roadmap, engineering leadership, technical due diligence, team building, delivery recovery and product strategy. 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐀𝐈 — production LLM/RAG/agent systems, PHI-safe architectures, AI evaluation, workflow automation and secure cloud deployment. 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐇𝐞𝐚𝐥𝐭𝐡 𝐀𝐫𝐜𝐡𝐢𝐭𝐞𝐜𝐭𝐮𝐫𝐞, 𝐇𝐈𝐏𝐀𝐀 & 𝐀𝐖𝐒 — PHI boundaries, healthcare architecture, IAM, encryption, audit logging, monitoring, CI/CD, vulnerability management, integrations, and operational evidence. 𝐒𝐚𝐌𝐃 / 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐝 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 — FDA 510(k), De Novo development, IEC 62304, ISO 13485/14971, cybersecurity, verification and submission-readiness. I am most useful when a company needs someone who can operate at the 𝐂𝐓𝐎 𝐥𝐞𝐯𝐞𝐥 𝐛𝐮𝐭 𝐬𝐭𝐢𝐥𝐥 𝐠𝐨 𝐝𝐞𝐞𝐩 𝐢𝐧𝐭𝐨 𝐚𝐫𝐜𝐡𝐢𝐭𝐞𝐜𝐭𝐮𝐫𝐞, 𝐬𝐞𝐜𝐮𝐫𝐢𝐭𝐲, 𝐀𝐈 𝐢𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐝 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭. If you have a digital-health or healthcare-AI product approaching an important technical, clinical, security, enterprise, regulatory, or commercialization milestone, send me the current state, the milestone, and what is blocking you. I can usually determine quickly where the real risk is and what should happen next.