Point of View
The Science Is Never the Problem.
Ninety percent of diagnostic technologies that clear validation never achieve sustainable adoption. The science works. The clinical data exists. Yet these innovations stall in the gap between the laboratory and the clinic.
The Commercialization Gap
Diagnostics Does Not Have a Science Problem. It Has a Commercialization Problem.
The cause is structural, not scientific. Evidence generation, regulatory strategy, reimbursement pathways, and market placement are treated as isolated silos. Each one optimized independently. None connected to a unified commercial outcome.
This pattern repeats across the diagnostic industry. Not because the science is weak, but because commercialization architecture is defined too late, or never defined at all.
Evidence Generation
Regulatory Strategy
Reimbursement Pathways
Market Placement
Integrated Commercial Architecture
Evidence aligned to payer logic
Regulatory pathway validated
Reimbursement codes mapped
Channel architecture defined
Launch sequence staged
Stakeholder narrative built
Our Mission
Architect diagnostic innovation toward adoption through commercial infrastructure designed for sustainable revenue.
We do not just offer advice. We engineer the structural integrity of your launch. By fusing disparate clinical and commercial requirements into a single, load bearing roadmap, we ensure your innovation achieves adoption.
Methodology
Why Architecture, Not Consulting.
Traditional consulting delivers recommendations. Architecture delivers infrastructure. The difference is the gap between a strategy deck and a functioning commercial system.
Our methodology sequences six decision layers, each resolving before the next begins, so commercial investment lands on structure rather than assumption.
The result: diagnostic companies that launch with the operating model, pricing architecture, and channel logic already validated, not retroactively assembled after clearance.
The Six Layers
Defining the market you will own and the category position that drives adoption.
Aligning clinical and economic data to payer and physician decision logic.
Designing the distribution pathway that matches your product to its buyer.
Building the coverage and coding foundation that unlocks sustainable revenue.
Staging market entry so every resource compounds toward early traction.
Ensuring your commercial story holds up to diligence from funders and partners.
Institutional Foundation
Institutional Access. Channel Authority. Field Credibility.
Built over 20+ years inside the diagnostic ecosystem, beginning in 2002.
Institutional Access
Engagement across federal health systems, state public health laboratories, and large integrated delivery networks.
Channel Authority
Designed and led national distributor architecture across acute and decentralized markets, including category alignment, field enablement, and launch sequencing.
Field Credibility
Led regional and national field sales organizations driving molecular and point-of-care adoption across complex care environments.
Acute Hospital Laboratories·Point-of-Care Settings·Consumer and OTC Diagnostics·State Public Health Laboratories·Federal Health Systems
Operator Experience
Operator experience across the diagnostic lifecycle.
01
Evidence Strategy
- Designed clinical study frameworks aligned to payer and physician decision logic
- Built evidence narratives connecting analytical performance to clinical utility
- Guided CRO selection, site sourcing, and predicate strategy for 510(k) submissions
02
Launch Architecture
- Architected go to market operating models from pre clearance through first revenue
- Built pricing frameworks grounded in reimbursement reality, not aspiration
- Designed launch sequencing across customer segments, geographies, and care settings
03
Channel & Distribution Design
- Led national distributor strategy, selection, and onboarding for new diagnostic platforms
- Built category positioning and listing strategy for major distribution partners
- Designed channel economics and incentive structures that align with adoption goals
04
Adoption and Scale
- Installed placement operating models that converted first use into repeatable utilization
- Built physician engagement and clinical narrative delivery systems
- Designed utilization tracking infrastructure to identify drop off and drive retention
Work with an operator.
Your diagnostic platform deserves a commercial model built to match it. Let us build it together.
In a confidential 30 minute session, we will review your current stage and identify the single most critical commercial risk to address before your next funding or launch milestone.