Advisory for Lab-Facing Companies
Embedding clinical fluency into the commercial strategy of companies that sell into, support, or scale alongside regulated laboratories.
Common Challenges That Trigger Advisory Engagements
Organizations typically seek advisory support when commercial momentum begins to outpace clinical and regulatory clarity. Common triggers include:
Products or platforms struggling to gain traction or “stickiness” in regulated labs
Sales and marketing messaging that doesn’t resonate with QA or Lab Directors
Commercial promises that create downstream compliance or operational risk for the customer
Uncertainty about how clinical regulators (CLIA/CAP) view a new technology or service
Difficulty navigating the “clinical gatekeepers” during the sales cycle
Growth that introduces systemic risk instead of sustainable scale
Investors or acquirers questioning the regulatory defensibility of the business model
If any of these feel familiar, advisory support helps bridge the gap between commercial goals and laboratory reality before they impact valuation or market share.
Designed for Organizations Selling into Regulated Labs
Advisory services are built for companies whose commercial success depends on regulated laboratory adoption. The buyer is typically a VP of Sales, Chief Commercial Officer, CEO, or Head of Product — who recognizes that laboratory market performance is not currently reflecting their organization's technical capability.
Primary Audiences:
In vitro diagnostics (IVD) manufacturers and distributors
Clinical diagnostic suppliers and reagent manufacturers
LIS/LIMS providers and laboratory software vendors
Analytical instrument companies (CAP/CLIA/ISO 17025)
Private equity-backed portfolio companies with laboratory-facing commercial operations
When Advisory Support Becomes a Commercial Requirement
Most lab-facing companies do not struggle due to a lack of technical innovation. Problems arise when the commercial team’s clinical fluency doesn’t match the laboratory’s operational reality.
Advisory engagements often begin when companies recognize that "selling" is no longer enough—they must demonstrate an understanding of the regulatory and quality burden their customers carry.
Key areas of alignment include:
Ensuring commercial promises don’t create audit findings for the customer
Building product roadmaps that reflect actual laboratory workflows
Bridging the gap between software capability and clinical validation
Aligning marketing messaging with CAP/CLIA expectations
Preparing for technical due diligence during investment or acquisition events
The goal is to move beyond being a vendor and become a defensible, trusted part of the laboratory’s clinical ecosystem.
Go-to-Market & Commercial Strategy
Aligning commercial objectives with the operational and regulatory realities of clinical laboratories.
Developing clinical fluency for commercial and sales teams
Refining product positioning for QA and Lab Directors
Identifying regulatory "gatekeepers" and anticipating objections
Ensuring commercial messaging is grounded in laboratory reality, mitigating clinical ‘deal-breakers’ early in the sales cycle.
Advisory Services
Fractional Clinical & Quality Advisory
For organizations that need experienced clinical laboratory leadership to support commercial or technical objectives.
Fractional Clinical Advisory for product development teams
Interim leadership during high-stakes commercial transitions
Executive coaching for commercial leaders entering the clinical space
On-call advisory for technical due diligence and market entry strategy
Product-Market Fit & Clinical Alignment
Ensuring that technical innovation translates into commercial value for regulated laboratories.
Aligning product roadmaps with clinical laboratory workflows
Bridging the gap between software/hardware capability and clinical validation
Anticipating technical and regulatory objections from QA and Lab Directors
Ensuring commercial messaging resonates with clinical gatekeepers
Due Diligence & Transaction Support
Independent clinical and regulatory risk assessment for investors, acquirers, and companies preparing for an exit.
Operational and regulatory due diligence for lab acquisitions
Commercial defensibility assessments for lab-facing technology
Risk exposure identification for PE-backed lab platforms
Technical due diligence for LIS/LIMS and diagnostic platforms
Regulatory Navigation for Vendors
High-level regulatory advisory to ensure products and services meet the expectations of clinical laboratory inspectors and auditors.
CLIA/CAP alignment and readiness strategy for product roadmaps
Audit and inspection risk assessment for vendor-provided services
Bridging technical specifications with quality system requirements
Guidance on CAPA philosophy and execution in a clinical context
Growth, Scale & Market Entry Strategy
Advisory support for companies expanding into regulated clinical markets for the first time.
Market entry strategy for CAP/CLIA regulated environments
Scale readiness assessments for growing lab service companies
Integration planning for new clinical capabilities
Leadership alignment during expansion or transition
The Month 1 Foundational Alignment
Standard engagements include two structured advisory sessions per month with ongoing asynchronous support.
Month 1 is built around establishing a foundational clinical fluency framework for your commercial team:
Week 1 — Leadership Calibration: Identifying growth priorities, commercial friction points, and regulatory translation gaps between your team and the lab buyer.
Week 2 — Clinical Credibility Framework: Introducing the contextual alignment framework that allows commercial teams to speak directly to lab operational realities.
Week 3 — Positioning & Messaging Review: Connecting your product categories to real-world laboratory pressure points: workflow, inspection risk, and staffing constraints.
Week 4 — Strategic Refinement: Identifying the highest leverage points in your sales cycle to reduce friction and improve adoption velocity.
How Advisory Engagements Work
Advisory engagements are structured to match your company's size, complexity, and specific commercial objectives. Common formats include:
Fixed-scope advisory assessments (e.g., market readiness reviews)
Ongoing monthly advisory retainers for leadership support
Fractional leadership roles for product or quality initiatives
Project-based due diligence for investments or acquisitions
All engagements are tailored to your commercial goals—not templated.
Tangible Outcomes of Advisory Support
By embedding clinical fluency into the commercial strategy, lab-facing companies can expect:
Stronger Sales Credibility: Sales and product teams that speak the "language" of lab directors and quality managers.
Improved Alignment: Product positioning that reflects the actual operational realities of regulated laboratories—not assumed ones.
Reduced Friction: Fewer roadblocks in executive purchasing discussions by addressing regulatory and workflow objections before they arise.
Increased Trust: Establishing your organization as a defensible, clinical partner rather than just another vendor.
Why Ron Brooks Consulting
Most advisors approach the laboratory market from the commercial side. They understand sales cycles, but they have not:
Managed a high-complexity regulated laboratory under inspection pressure.
Built quality systems from the ground up to withstand federal and state-level audit scrutiny.
Negotiated with regulatory bodies or made capital decisions inside an accredited testing environment.
Bridged the gap between vendor promises and laboratory reality as an operator.
Ron Brooks has — across clinical, analytical, environmental, and specialty laboratory environments.
This advisory closes the credibility gap from the inside out.
Advisory vs. Consulting Services
Advisory services focus on strategy, clinical alignment, and commercial leadership guidance.
For organizations requiring hands-on implementation, SOP development, or execution-focused work, please see our Clinical Laboratory Consulting page.
Let’s Talk
If you are building products or services for clinical laboratories and are navigating regulatory pressure, growth, or strategic uncertainty, a short conversation can help clarify your next steps.