Predetermined Change Control Plans: How AI Medical Devices Get FDA Clearance to Keep Learning
July 27, 2026
A traditional FDA clearance freezes your AI device in place — every retrain or improvement risks a new submission. A Predetermined Change Control Plan is how you get cleared to keep updating. This guide covers what a PCCP is, its three required components, and what it demands of your engineering.
EHR Integration for Healthcare AI Startups: FHIR, Epic, and the Patterns That Get You Past Hospital Procurement
May 29, 2026
HIPAA makes you legal. FDA clearance makes you sellable to clinicians. Neither gets you into a hospital. This guide covers the integration standards, vendor marketplaces, and procurement realities that decide whether a healthcare AI product ships into real clinical environments — or sits on a shelf with a great demo.
When GPU Acceleration Moves the Needle: Dayhoff Health and AMD Report a 330x Speedup on Microbiome Analysis
April 23, 2026
Our client Dayhoff Health, working with AMD, benchmarked an AMD Radeon AI PRO R9700 against a Ryzen 7950X on production genomics pipelines. Here is what a 330x speedup on microbiome analysis actually means for healthcare companies running sequencing at scale.
HIPAA-Compliant AI Development: A Practical Guide for Healthcare Startups
August 6, 2025
Building AI into a healthcare product means navigating HIPAA from your first line of code. This guide covers what HIPAA actually requires of software, how to architect for compliance, and the common mistakes that expose startups to breach liability.