We've reached a major milestone: our Minimum Viable Product (MVP) is complete. Here's what we've built, what we've learned, and our roadmap for the next 12 months to MHRA authorization.

What We've Built

As of Q3 2025, HeAIth's core technical foundation is in place:

1. AI Diagnostic Engine

• Trained on medical literature, symptom-disease associations, and clinical guidelines
• Capable of generating differential diagnoses from presenting complaints
• Recommends appropriate initial investigations for early diagnostic workup
• Flags red-flag symptoms requiring urgent attention

2. Clinical Interface

• Intuitive symptom input system designed for fast consultation environments
• Clear, evidence-based output format with clinical reasoning
• Designed to integrate into existing clinical workflows
• Mobile-responsive for use on tablets and laptops

3. Technical Infrastructure

• Secure, GDPR-compliant data architecture
• Designed for future NHS system integration (HL7 FHIR ready)
• Real-time performance with sub-second response times
• Audit logging for clinical safety and post-market surveillance

What We've Learned

Building the MVP taught us critical lessons:

1. Accuracy vs. Comprehensiveness Trade-off

Early iterations generated too many differential diagnoses (30+ for common presentations like chest pain). We've refined the algorithm to prioritize clinically relevant differentials based on prevalence and severity, typically showing 8-12 key possibilities.

2. The Importance of Clinical Reasoning

Clinicians don't just want a list of diagnoses—they want to understand why the AI is suggesting them. We added explainability features showing which symptoms and red flags drive each differential.

3. Speed Matters

In 10-minute GP consultations and busy A&E departments, every second counts. We optimized response times to under 2 seconds, ensuring HeAIth assists rather than hinders clinical workflow.

What's Missing (And Why)

Our MVP is functional but not finished. Here's what we still need:

• Clinical validation – Multi-site studies to validate accuracy across diverse patient populations
• Bias testing – Ensuring the AI performs equitably across age, sex, and ethnicity
• Real-world usability testing – Input from frontline clinicians on workflow integration
• NHS interoperability – Full HL7 FHIR integration with GP systems and EPRs
• Regulatory compliance – ISO 13485 QMS, Clinical Safety Case Report (DCB0129), MHRA submission

This is where you come in. We're recruiting clinical advisors to guide this next phase of development.

Roadmap: The Next 12 Months

Q4 2025: Advisory Board Formation

• Recruit 3-5 founding clinical advisors (GPs, A&E consultants)
• Establish governance structure and strategic direction
• Initial product review sessions with advisor input

Q1 2026: Product Refinement & Regulatory Foundations

• Algorithm improvements based on clinical feedback
• UI/UX optimization for real-world workflows
• ISO 13485 QMS implementation begins
• Clinical Safety Officer appointment
• Data Protection Impact Assessment (DPIA) completion

Q1-Q2 2026: Seed Funding Round

• Target raise: £500k-700k
• Use of funds: 35% regulatory compliance, 25% clinical validation, 25% product, 15% team
• Investor presentations with realistic timeline and budget

Q2-Q3 2026: Clinical Validation & MHRA Submission

• Multi-site clinical validation studies with NHS trusts
• NHS DTAC completion (Cyber Essentials, FHIR interoperability)
• Q2 2026: MHRA UKCA submission (Class IIb SaMD)
• UK Approved Body conformity assessment
• Q3 2026: Target MHRA market authorization

Q3 2026: Limited Market Release

• 2-3 NHS trust pilot deployments
• Post-market surveillance activation
• Continuous performance monitoring and refinement

Why We're Transparent About What's Not Ready

Many healthcare AI companies claim their products are "ready" when they're not. We're taking a different approach: radical transparency.

HeAIth is not yet approved for clinical use. It won't be until Q3 2026 at the earliest. We're showing you the MVP to demonstrate technical feasibility and invite collaboration, not to claim we're market-ready.

This honesty builds trust with advisors, investors, and future customers. It also sets realistic expectations about the 12-18 month regulatory pathway required for any Class IIb medical device.

Join Us on This Journey

MVP complete is a milestone, but it's just the beginning. The next 12 months will determine whether HeAIth becomes a valuable clinical tool or just another failed healthcare AI project.

We need your expertise to make this work.