Services
From Clinical Validation to Market Adoption
Built on over two decades of navigating the diagnostic commercialization window for global leaders and emerging startups. We design and install the go-to-market strategy, channel infrastructure, and revenue architecture that takes a diagnostic platform from clearance to commercial traction.
Strategy
Go-to-Market Architecture
Pricing, channel, and launch sequencing
Global
US Market Access
Regulatory sequencing and channel entry
Growth
Commercial Infrastructure
CRM, ROI models, and field operations
Precision commercial architecture across molecular diagnostics, point of care testing, and decentralized testing environments.
Commercial Framework
Three Pillars of Diagnostic Commercialization
Every engagement is structured around three interdependent pillars that convert regulatory clearance into repeatable market adoption.
01
Evidence Strategy
Architect go-to-market sequencing, pricing logic, and clinical utility mapping for the 0-to-1 commercialization window.
Focus Areas
- Go-to-Market Strategy and launch sequencing
- Pricing Architecture anchored to workflow economics
- Clinical Utility Mapping for buyer procurement confidence
Strategic Deliverables
Clinical Utility Mapping
Link analytical claims to physician decision-making criteria and payer coverage triggers.
Economic Value Narratives
Build evidence-based ROI models that translate clinical outcomes into procurement language.
02
Market Access
Prioritize regulatory sequencing and reimbursement alignment to compress time from clearance to contracted clinical use.
Focus Areas
- Regulatory Sequencing to prevent capital burn before market entry
- Reimbursement Alignment for sustainable coverage and coding strategy
- Channel Access Optimization by readiness and workflow fit
Strategic Deliverables
CPT/PLA Coding Strategy
Navigate coding pathways to establish reimbursement identity and accelerate payer onboarding.
Regulatory-Payer Sequencing
Align FDA submission timing with coverage decisions to compress the commercialization window.
03
Adoption Infrastructure
Install execution systems that sustain adoption velocity from pilot placement through national distribution.
Focus Areas
- ROI Modeling for provider and payer stakeholder defense
- Pitch Optimization with evidence-based value narratives
- Early Revenue Execution for repeatable, contracted adoption cycles
Strategic Deliverables
Physician Workflow Integration
Map adoption triggers to clinical workflow to reduce ordering friction and sustain utilization.
Commercial Readiness Scorecards
Structured assessment of launch infrastructure across sales, operations, and channel readiness.
Focused Exclusively on Diagnostic Commercialization
AdvisoryDx operates in a single vertical. Every engagement, framework, and deliverable is purpose built for the regulatory, reimbursement, and commercial dynamics of the in vitro diagnostics market.
Deliverables
Commercial Architecture Deliverables
Each engagement produces a tailored set of deliverables designed for your stage, market, and regulatory position.
Market Entry Strategy
Define care-setting priorities, buyer pathways, and launch sequencing for initial market penetration.
Pricing Optimization Model
Structure pricing logic anchored to clinical utility and workflow economics, not competitor benchmarks.
Product Launch Blueprint
Operationalize the full launch sequence from regulatory clearance to first contracted adoption.
National Distribution Roadmap
Map distributor selection, margin architecture, and channel expansion for scalable national coverage.
Competitive Positioning Brief
Articulate defensible positioning against incumbents and adjacent market entrants.
Sales Enablement Program
Equip field teams with evidence-based tools, ROI frameworks, and objection handling for complex sales cycles.
Case Studies
Where the Architecture Leads
Case Study
Molecular Platform Commercialization
Translated regulatory progress into adoption momentum by sequencing evidence milestones, building clinical utility positioning for formulary discussions, and installing revenue infrastructure before national expansion.
Read the Full Case StudyCase Study
Decentralized Testing Market Launch
Scaled decentralized testing adoption by identifying early sites with the strongest workflow fit, engineering go-to-market sequencing for rapid first contracts, and deploying sales infrastructure that sustained post-launch velocity.
Read the Full Case StudyMethodology
The AdvisoryDx Methodology: A 6-Layer Decision Architecture
Every engagement is sequenced through six interdependent decision layers. This architecture replaces ad-hoc consulting with a structured commercialization operating system.
Engagement Model
Every Engagement Begins with a Diagnostic Sprint
Before we build, we assess. The Diagnostic Sprint is a 2 to 4 week structured evaluation of commercialization readiness that identifies architecture gaps, sequences priorities, and produces the architecture brief that scopes the full engagement.
2 to 4 weeks
Diagnostic Sprint
Diagnose commercialization risk and issue a prioritized architecture brief.
Key Vectors
- Assess revenue sequencing readiness across channels
- Sequence regulatory priorities by commercial impact
- Map clinical utility gaps before scale commitments
Flat fee engagement, scoped before kickoff.
6 to 12 weeks
Architecture Build
Build full commercialization architecture for launch readiness and disciplined execution.
Key Vectors
- Design operating model across strategy and infrastructure
- Build launch plan aligned to decentralized testing expansion
- Install governance cadence for commercial decision control
Milestone fee schedule tied to delivery gates.
Quarterly
Ongoing Advisory
Direct access to 25 years of IVD leadership and 12 years of early stage diagnostic scaling.
Key Vectors
- Guide board level decisions with execution data
- Adjust sequencing based on channel performance signals
- Reinforce team accountability against growth objectives
Monthly retainer, limited annual capacity.
Not Sure Which Pillar You Need First?
Most engagements start with a conversation about where you are stuck.
No pitch. Just a clear recommendation on where to begin.