Market Access Built on Honest Commercial Diagnostics

Senior commercial leadership for the market access decisions that determine commercial viability — integrating regulatory pathway, payer economics, and healthcare practitioner adoption into honest go/no-go recommendations. Built on 30 years across pharma, biotech, and medical devices, with deep specialty pharmacy and managed care experience.

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3 Pillars

Regulatory · Payer · HCP Adoption

Honest

Go/no-go diagnostics

30 Years

Specialty pharmacy and managed care experience

The Market Access Diagnostic That Tells the Truth

Most market access work optimizes a commercial path that has already been chosen. ISG’s market access work asks the harder question first: is there a viable commercial path at all? We integrate regulatory pathway, payer economics, and healthcare practitioner adoption into a single diagnostic — and are willing to conclude, when the data demands it, that the right answer is to walk away.

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That intellectual honesty is the discipline that makes the recommendations worth acting on. A market access diagnostic that always concludes with "yes, here’s how to optimize the path" is not a diagnostic — it’s an upsell. ISG works the other way.

  • Regulatory pathway mapping and feasibility assessment
  • Payer economics and reimbursement modeling
  • Healthcare practitioner adoption diagnostics
  • Specialty pharmacy and managed care strategy
  • Commercial viability synthesis across the three pillars
  • Investment recommendations grounded in honest diagnostics
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Outcomes That Determine Whether to Build, Pivot, or Stop

Market access work at ISG produces the four outcomes a commercial leader needs before committing further capital to a launch.

OUTCOME

Regulatory Pathway Clarity

Honest assessment of which regulatory pathways are viable, what each requires, and how regulatory strategy interacts with commercial timing.

OUTCOME

Payer Economics That Hold Up

Reimbursement modeling, pricing strategy, and the economic case payers will actually accept — built on direct experience across specialty pharmacy, managed care, and commercial payer channels.

OUTCOME

HCP Adoption Reality

The diagnostic question that often gets skipped: will the healthcare practitioners who would prescribe, recommend, or use this product actually do so — and at what rate, against what alternatives, with what behavior change required?

OUTCOME

Commercial Viability Synthesis

Integration of all three pillars into a single, decision-grade synthesis: build, pivot, or stop. Not optimization theater — actual recommendations that founders, boards, and investors can act on.

How We Approach Market Access

Methodology built on 15+ product launches and senior executive experience across specialty pharmacy and managed care — informed by the operational reality that market access success or failure is determined by the interaction of three pillars, not any one of them alone.

01

Regulatory Pathway Mapping

Identify all viable regulatory pathways, the requirements and timeline of each, and the commercial implications of choosing among them.

02

Payer Economics Modeling

Build the payer-level economic case: reimbursement scenarios, pricing strategy, channel economics, and the value proposition payers will accept.

03

HCP Adoption Diagnostic

Assess realistic adoption rates among the healthcare practitioners who would use the product — including behavior change required, alternatives in use, and the strength of the clinical and economic case from the practitioner’s perspective.

04

Commercial Viability Synthesis

Integrate the three pillars into a single commercial viability assessment: where the path is open, where it is constrained, and where it is not viable.

05

Investment Recommendation

Translate the synthesis into a clear recommendation — proceed and at what scale, pivot and to what alternative, or stop and recover the capital. Honest recommendations, even when they’re hard.

Where Market Access Engagements Concentrate

Core strategic pillars that drive successful commercialization and long-term market success.

  • Regulatory Pathway Assessment
    • 510(k), De Novo, PMA, and exempt pathway evaluation
    • Regulatory timeline and resource requirements
    • Commercial implications of regulatory choices
  • Payer Economics & Reimbursement
    • Coverage and reimbursement scenario modeling
    • Pricing strategy and economic case development
    • Coding and channel economics
  • Specialty Pharmacy & Managed Care
    • Distribution and channel design
    • Managed care and PBM strategy
    • Specialty pharmacy network strategy
  • HCP Adoption Diagnostics
    • Realistic adoption rate assessment
    • Behavior change requirements analysis
    • Competitive and alternative landscape evaluation
  • Pricing Strategy
    • Value-based pricing models
    • Cost-effectiveness positioning
    • Pricing scenario sensitivity
  • Commercial Viability Synthesis
    • Three-pillar integration
    • Build/pivot/stop recommendations
    • Honest go/no-go diagnostics

Companies This Engagement Is Built For

Bootstrapped Founders Evaluating Commercial Investment

Founders who have invested personal capital and need an honest senior commercial perspective on whether to keep going, pivot, or stop — before committing further resources.

Companies with Cleared Regulatory but Uncertain Commercial Path

Companies that have viable regulatory pathways but face uncertainty on payer economics, HCP adoption, or both — and need a diagnostic that integrates all three before commercial investment scales.

Investors Evaluating Medical Device Commercial Viability

Venture and specialty investors performing commercial diligence on medical device or specialty pharma assets where the regulatory question is settled but the commercial question is not.