Fractional
Leadership
Deep Domain
Expertise
De-risk Commercialization
Clarity AI HITL Commercial Workflow
Experienced Leadership
Team
We offer both customized and tailored programs designed to meet your needs. Our tailored programs are structured, evidence-based programs designed to move you through the critical stages of launch, adoption, and scale. Each program is built as a focused sprint or accelerator, board-ready, fast to start, and tailored to the realities of regulated markets.
What this means in practice:
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Fast Start Programs (1–9): Quick, high-impact sprints (1–4 weeks) that solve specific bottlenecks — from product-market fit and market access to GTM and regulatory readiness.
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Commercialization Accelerator (10): Precision Commercialization Accelerator: A multi-quarter program that integrates all elements into a full commercialization engine.
What You’ll Gain:
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A commercialization framework to unlock early traction
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Messaging and access tools that drive adoption
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A 90-day action plan built for results
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Bonus: VSL training to pitch payers, providers, and partners
We help life sciences launch and scale from access to revenue. More information can be found at Commercial Solutions
1. Product Market Fit
Who it’s for
Founders, clinical/medical leads, and commercial executives in:
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Biotech & Pharma
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AI-health / Digital Health
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MedTech & Diagnostics
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Teams preparing to raise, launch, or scale
What’s included
A 4-step framework to pressure-test whether your product truly fits the market:
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Deep Discovery — Current validation, hypotheses, and GTM assumptions
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Stakeholder Mapping — Influencers, buyers, payers, and end users across the ecosystem
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PMF Assessment — Fit scored across clinical, operational, financial, and regulatory dimensions
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Execution Roadmap — Concrete recommendations for launch, adoption, and scale
Deliverables:
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Board-ready PDF with findings, gaps, and go/no-go signals
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“Do / Don’t / Defer” 90-day plan
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Stakeholder alignment map
How it works (≈2 weeks)
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Week 1: Discovery intake + stakeholder mapping
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Week 2: Assessment & roadmap creation
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Touchpoints: 2× 90-min working sessions + final 60-min readout
Why it matters
Most failures come not from weak science or tech, but from misjudged fit.
This sprint de-risks investment, sharpens board narratives, and saves months of wasted spend.
Ready to assess your real product-market fit?
2. Life Science Market Primer
Who it’s for
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Pharma
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Biotech
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Diagnostics
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AI-health
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Digital Health
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Medical Device
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MedTech
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Teams new to US/Canada
What’s included
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Pathway
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Coding
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Reimbursement (US or Canada) with earliest/likely/latest timing bands
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Buyer & stakeholder map (who pays / blocks / influences)
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Access basics & exemplar codes (J-codes / DRGs / provincial analogues)
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Net price corridors
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Contracting guardrails
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Channel norms + 3–5 comparators
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RWE 101 (what HTAs/payers actually accept)
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US ↔ ex-US translation callout (what changes, why)
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90-day Do / Don’t / Defer plan + risk register
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60-min live readout (Medical Director context; not medical advice)
How it works
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1-week sprint
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Intake (form or 30–60 min)
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2–4 business days analysis
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60-min readout + board-ready PDF
3. Market Access & Country Entry
Who it’s for
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Founders
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CMO
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Market Access
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Commercial leads planning US/Canada/EU entry
What’s included
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Country sequence (first + follow-on) with timing bands & PoS
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Access pathway map (e.g., 510(k)/NDS/CE → codes → coverage)
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Pricing & contracting guardrails (list/net bands, discount rules, distributor margins)
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HTA evidence grid (accepted endpoints/forms by body)
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Tender readiness checklist (medtech/procurement specifics)
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JIC playbook (delay, price pressure, competitor entry)
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90-day action plan to lock milestones, dossiers, partners
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AI Governance mini-kit (included if AI-enabled product)
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policy outline
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risk register
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control checklist
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HITL checkpoints
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How it works (~1 week)
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Short intake
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mapping
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60-min readout
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concise PDF
4. 30 Day GTM Operating System
Who it’s for
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Seed–Series C life sciences & AI-health
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SMB/enterprise BUs with fragmented GTM
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ex-US building a NA motion
What’s included
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ICP & message hierarchy (pain → proof → promise)
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Channel strategy (direct vs distributor/partner; territory/partner map)
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Pricing guardrails (list→net corridors, discount rules, deal-desk triggers)
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Objection library + enablement pack (battlecard, first-touch email/call script, 1-pager)
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90-day commercialization calendar with owners
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KPI stack & WBR cadence (weekly business review) + access-slip metric
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Risk & mitigation (“if slip, then do”) + board one-pager
How it works (4 weeks)
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Week 1 ICP & proof
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Week 2 channels & map
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Week 3 offers & guardrails
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Week 4 calendar, KPIs, cadence.
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Touchpoints: 4× 90-min working sessions + async drafts; final 60-min readout.
Who it’s for
Leaders allocating capital across markets/indications/channels
What’s included
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Quantified top 3–5 growth paths (P10/P50/P90)
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rNPV/IRR by strategy + Monte Carlo guardrails
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Price-erosion sensitivity (rebates/discounts, payer pressure)
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Competitive & access benchmarks; breakeven timing
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Do / Don’t / Defer plan with owners and next-quarter steps
How it works
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(3–5 business days)
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Intake (≤12 prompts) → modelling & scenarios → 60-min readout + PDF brief.
Book a 20-min fit call →
Who it’s for
Founders raising; investors & BUs comparing assets; M&A/BD.
What’s included
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Market size, access, competition realism
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rNPV/IRR/MOIC scenarios + sensitivity/tornado
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RWE sufficiency check (payer/HTA credibility)
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Ex-US translation risk (what breaks crossing borders)
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Red flags with specific mitigations
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Decision memo: go / hold / no-go
How it works
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~5 business days
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Targeted data room/links
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Evidence triangulation + simulations
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Memo readout
CTA: Book a 20-min fit call →
7. Regulatory Readiness
Who it’s for
MedTech/IVD/Diagnostics, Digital Therapeutics/SaMD/AI-health, and Pharma/Biotech teams planning US/Canada/EU submissions or label changes.
What’s included
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Route & classification: FDA / Health Canada / EU (MDR/IVDR) options
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Claims & indication risk map: what you can credibly say now vs. after added evidence
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Dossier gap map: clinical + non-clinical + QMS gaps
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Pre-submission plan: Q-Sub / scientific advice topics, meeting objectives, draft questions
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Submission timeline & owners: critical path, dependencies, required vendors/notified body touchpoints
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Regulatory risk register & JIC plan: delays, evidence shortfalls, NB capacity, remediation triggers
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90-day action plan: Do / Don’t / Defer, with evidence and document tasks
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AI governance (included for software/AI): SaMD/ML risk controls
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HITL checkpoints, change-control, monitoring outline (EU AI Act context)
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How it works
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≈1 week
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Short intake
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assessment & gap mapping (2–4 business days)
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60-min readout + concise, board-ready PDF.
Add-ons
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Submission Readiness Sprint™ (2–4 weeks)
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Q-Sub package prep, meeting support, document skeletons (510(k)/De Novo/PMA
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IVDR tech file/CER/PER; IND/CTA/NDS/505(b)(2) scaffolds)
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Labeling/UDI plan • NB/RA vendor screening
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ISO 13485/QMS gap checklist
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Protocol synopsis for performance/clinical study
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AI Governance Pack (expanded templates, DPIA/TRA outline, rollback tests) for AI/SaMD
CTA: Book a 20-min fit call →
Who it’s for
Teams with a defined use case who need a governed pilot → production quickly.
What’s included
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Working pilot integrated to your stack (e.g., CRM/SharePoint/Drive/API)
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Governance baked in: policy outline
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HITL workflow, monitoring & logs, model/card documentation, rollback plan
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Compliance alignment: EU AI Act context + HIPAA/PHIPA/PIPEDA considerations (no legal advice)
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Acceptance tests & success metrics; enablement runbook; admin checklist
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Security/privacy alignment: BAAs/DPAs as needed; data residency plan
Common tracks (pick one to start)
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Compliant Content Copilot (MLR guardrails, citations, change logs)
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Forecasting & Next-Best-Action (demand/territory; CRM guidance)
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KOL & Evidence Insights (lit + KOL graph; brief generation)
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Quality/Regulatory QA (SOP checks, audit trail)
How it works & timeline
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Phase 0 (2 weeks): tech discovery, data access, acceptance criteria
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Phase 1 (30 days): pilot build, user testing, governance sign-off
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Phase 2 (30–60 days): hardening, controls/monitoring, limited production
9. Commercial Team Optimization
Who it’s for
Fix or scale sales, marketing, and access.
What’s included
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Org & role map with gaps and overlaps
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Workflow diagnosis (lead→close; MA handoffs) and bottlenecks
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KPI stack & WBR cadence (pipeline stages, exit criteria, dashboards)
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Enablement gaps (battlecards, scripts, content) and training plan
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RACI & handoff rules across sales/marketing/MA/Medical
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Hiring & capacity plan (roles, profiles, sequencing)
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Risk register (slips, dependencies) with mitigations
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90-day action plan, Do / Don’t / Defer with owners and dates
How it works
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1–2 weeks
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Intake (questionnaire + brief interviews)
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operational review
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60-min readout + concise PDF.
Add-ons
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90-min enablement workshop
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Light RevOps setup
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CRM stages, fields, dashboards
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30-day office hours
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AI Governance Pack (if your team uses AI content/tools).
Scope & terms
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Advisory deliverable; no HR/legal services
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Timelines assume timely inputs and access
10. Commercialization Accelerator
Who it's for
teams past early wins who must cross the adoption chasm: longer cycles, slow committees, procurement friction, global complexity.
What it is
A structured, operator-led program that blends market intelligence, modeling, and hands-on enablement to move you from stall points to scalable growth.
What You Get
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Pipeline & Friction Map — where deals stall from first touch to renewal.
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Stakeholder & Committee Journeys — how decisions actually get made (and blocked).
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Segmented GTM Playbooks — messaging, cases, procurement paths, enablement.
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Channel & Integration Roadmap — priority partners and activation steps.
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Board-Grade Expansion Models — scenarios with risk, timing, and ROI.
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Leadership Enablement Plan — sessions that lock ownership and action.
How It Works
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Discovery & Data Mapping — interviews, pipeline review, customer signals.
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Onsite Collaboration — focused “war room” working sessions.
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HITL Market Intelligence — multi-model analysis guided by operators.
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Strategy & Enablement Delivery — executive assets + micro-training to embed.
Who It’s For
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Life Science, AI, and SaaS teams ready to scale.
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Orgs facing longer cycles, complex buyers, or channel expansion.
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Leaders who want accountable, actionable diagnostics—not theory.
Why Strategic Growth AI
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Operator-led — launches rescued and scaled in regulated markets.
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Human-in-the-loop clarity — cross-validated insight, not raw outputs.
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Board/investor-grade — every deliverable built for decisions.
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True partnership — we work beside your team until insight becomes revenue.
Visit Precision Commercialization