Class III Medical Devices & Advanced Therapeutics
rethink

REGULATORY & MARKET
ACCESS.

Transforming regulatory & market access workflows — powered by Mergent X

Phase-Four unifies fragmented clinical, regulatory, and payer data into a single AI framework — powered by Mergent X, the interoperability standard transforming regulatory and market access workflows for the world's most complex devices.

The Problem

DATA SILOS
DELAY DECISIONS
THAT MATTER.

Life science companies operate across fragmented data ecosystems — clinical registries, payer databases, regulatory dossiers, and outcomes data are siloed. The result: slower submissions, missed market access windows, and evidence gaps that cost years.

68%
of Class III devices face FDA submission delays attributable to inadequate SaMD & PCCP planning
48%
increase in SaMD-related adverse events & recalls over 24 months
— SOLUTION
MERGENT X
Powered by Phase-Four.co · P4

Mergent X is the interoperability standard that transforms how regulatory and market access workflows operate — connecting fragmented clinical, payer, and regulatory data into a unified intelligence layer.

🔗
Interoperability Standard
Unifies siloed registries, payer databases, and regulatory dossiers via FHIR, HL7, and proprietary connectors
📋
Regulatory Workflow Transformation
Automates SaMD, PCCP, and PMA evidence synthesis — closing submission gaps before they stall FDA and EU MDR
💊
Market Access Workflow Transformation
Connects HTA decisions, payer signals, and HEOR models in real time — compressing the path to covered indication
The Interoperability Dilemma

THE COST OF
FRAGMENTED DATA

Without a unified intelligence layer, siloed systems create compounding delays across every critical decision point.

R&D Cycle Time
Without Interoperability
7.2 yrs avg
Manual registry cross-referencing · Duplicated evidence synthesis
Mergent X↓
With P4 · Mergent X
3.8 yrs avg
Unified registry ingestion · Real-time evidence gaps
FDA PMA Approval Rate
Without Interoperability
32% first-cycle
Incomplete SaMD documentation · PCCP gaps
Mergent X↓
With P4 · Mergent X
78% first-cycle
Predictive deficiency modeling · SaMD/PCCP readiness scoring
Payer Coverage Speed
Without Interoperability
24+ months
Fragmented HTA evidence · Disconnected RWE
Mergent X↓
With P4 · Mergent X
8–10 months
Live HTA signal indexing · Pre-built HEOR dossiers
P4 Intelligence Engine · Live
2.4M+
Registry Patient Records
47+
Payer Markets Indexed
98%
Dossier Accuracy Score
3×
Faster HTA Readiness
MDR / EU Class III
FDA PMA Strategy
HTA & HEOR Modeling
Real-World Evidence
Payer Negotiation Intel
Post-Market Surveillance
Get Started

REDEFINE YOUR
EVIDENCE STRATEGY

See how Phase-Four's P4 Intelligence Framework can compress your path from clinical data to covered indication.