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HealthtechMedScan AI

Scaling AI-Powered Diagnostics for a Healthtech Startup

How we helped a healthtech startup go from prototype to production with their AI diagnostic tool, achieving 95% accuracy.

95%
Diagnostic Accuracy
-60%
Processing Time
Cleared
FDA Pathway

The Challenge

MedScan AI had a promising prototype for AI-assisted medical image analysis. Their model showed strong results in the lab, but they faced three critical challenges:

  1. Production readiness — the prototype couldn't handle real-world image variability
  2. Regulatory compliance — they needed to demonstrate FDA-quality validation
  3. Scale — processing times were too slow for clinical workflows

Our Approach

We provided an AI Stack Audit followed by 12 weeks of Hands-On Build Advisory focused on production hardening.

Audit Phase

  • Evaluated model architecture and identified bottlenecks
  • Reviewed data pipeline for bias and quality issues
  • Mapped regulatory requirements to technical specifications

Build Phase

  • Redesigned the inference pipeline for 60% faster processing
  • Implemented comprehensive logging and audit trails for FDA compliance
  • Built a robust evaluation framework with clinician-validated test sets
  • Added edge-case handling for image quality variations

The Results

  • 95% diagnostic accuracy validated against expert clinician panel
  • 60% reduction in processing time, now compatible with clinical workflows
  • FDA 510(k) pathway cleared with comprehensive validation documentation
  • $4M Series A raised with the production-ready AI as a key differentiator

Client Testimonial

"Opscale brought the engineering rigor we needed to go from 'cool demo' to 'FDA-ready product.' They understood both the technical and regulatory challenges."

— Dr. James Park, CEO at MedScan AI