We build the science and AI behind validated digital health

From regulated devices to science-backed wellness, we combine deep health science with production AI engineering to build products that work, validate, and ship.

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Health Science AI Engineering Regulatory Fluency
Our Solution

Health Science + AI Engineering, End-to-End

Health Science
Metric Design
Clinical Validation
Study Design
Endpoint Development
+
AI Engineering
Computational Models
Production AI
LLM & Agentic Systems
Probabilistic Inference
Shared Foundation
Regulatory Fluency Interpretability Uncertainty Quantification Delivery

Engagements can be science-led, engineering-led, or both.
Not just advisors. We build.

Our Edge

Health Science Meets Production AI

We ship systems, not slide decks
Most consultants advise. We build production AI, validated metrics, and deployment-ready pipelines.
AI built for regulators from day one
Interpretable, uncertainty-aware, and audit-ready — designed for regulatory scrutiny, not retrofitted.
One team, bench to production
No handoff between advisors and builders. Our scientists code and our engineers understand clinical endpoints.
Akili — FDA De Novo Clearance Pear — First Rx DTx UCSF Neuroscape
The Team

Our Team's Collective Experience

3
FDA Clearances
200+
Publications
100+
Years Combined Experience
Akili EndeavorRx / EndeavorOTC — First FDA-cleared video game therapeutic (ADHD)
UCSF Neuroscape — Pioneering cognitive neuroscience-to-technology translation
Pear reSET — First FDA-authorized prescription digital therapeutic (SUD)
Cognivive — VR-based cognitive rehabilitation (acquired by REACT Neuro)
Akili Pear Therapeutics UCSF UC Davis Slingshot AI PyMC
Our Clients

Who We Serve

Digital Therapeutics

Series A–C companies needing metric validation, AI systems, and FDA strategy

Pharma

Digital biomarkers for trials and novel digital endpoints

Health Tech & Wellness

Validation frameworks, regulatory pathways, and science-backed product claims

Health AI Companies

FDA-ready AI architecture, regulatory strategy, and technical due diligence for AI/ML products

We also work with: Investors seeking technical due diligence · Boards needing AI readiness audits · Acquirers evaluating digital health targets
Our Process

How We Work

Start small. Validate fit. Then build.

1

Discovery

~1 month

A focused engagement to assess feasibility, understand your data, and scope the build.

  • Stakeholder interviews and goal alignment
  • Technical and scientific assessment
  • Regulatory pathway analysis
  • Prioritized roadmap with build options
2

Build

3–8 months

Project-based engagements to design, validate, and deploy metrics and AI systems.

  • Metric specification and design
  • Algorithm development and feature engineering
  • Validation studies
  • Production deployment
3

Support

Ongoing retainer

Retainer relationships for scientific advisory and continued iteration.

  • Ongoing advisory access
  • Model monitoring and updates
  • Regulatory support
  • Strategic guidance
Get Started

Let's Talk

Start with a conversation. We'll discuss your goals, assess fit, and determine whether a Discovery engagement makes sense.

andy@cognitiveinsightconsulting.com