We build the science and AI behind validated digital health

From regulated products to science-backed wellness, we combine deep expertise in cognitive, neurological, and behavioral health 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 SaMD & Digital Therapeutics Interpretability Uncertainty Quantification Delivery

Advisory. Fractional leadership. Hands-on build.
From strategy through production — one team, end-to-end.

Our Edge

Health Science Meets Production AI

Advisory to deployment, one team
Strategy, fractional leadership, or full build — we go as deep as the engagement demands. Production AI, validated metrics, and deployment-ready pipelines.
Regulatory-ready AI, from day one
When the product demands it — interpretable, uncertainty-aware, and audit-ready. Designed for regulatory scrutiny, not retrofitted.
One team, bench to production
No handoff between siloed subgroups. 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
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

~1–6 months

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

  • Engineering-led (AI system, pipeline, deployment): ~1–3 months
  • Science + validation (metric design, study, clinical endpoints): ~3–6 months
  • Algorithm development and feature engineering
  • Production deployment
3

Support

Ongoing retainer

Retainer relationships for scientific advisory, fractional leadership, 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