Commercialization
Solutions

​​​Our solutions are purpose-built to accelerate evidence, access, adoption, and investor readiness for medical devices, diagnostics, AI-health solutions, and biopharma.

 

Each offering reflects real-world commercialization pain points of innovators, scalers, and investors—with a focus on measurable milestones and compliance discipline.

Primary CTA: Book a 15-min Fit Call

 

1. Market Access & Reimbursement

Accelerate coding, coverage, and first paid claims in the US & Canada.

 

Proof Points

• First paid claim milestone often achieved within 90-240 days of payer submission*

• 20–60% lives covered typically achieved within 12 months of policy issuance*

• MAC/Provincial pathways mapped with jurisdiction-level analysis

 

Scope & Deliverables

• Coverage plans, payer LOIs, claim kits

• CPT/HCPCS strategy dossiers + clinical vignettes

• NCD/LCD petition and Provincial payer dossiers

• RWE/HEOR access plan tied to payer needs

• Cross-border US/CA choreography with coding approaches

• Claim support pack with coding guidance & templates

 

Disclaimer: We advise on strategy and dossier preparation. Coverage and payment decisions rest solely with payers and regulatory bodies. No guarantee of coverage is made.

 

2. Regulatory Pathway & AI Governance (PCCP-Ready)

PCCP-ready clearances you can defend, with safe ML updates.

 

Proof Points

• Submissions accepted on first pass without AI-related RTA requests in prior engagements*

• PCCP protocols fully documented with rollback criteria

• Label and claims governance aligned with payer scrutiny

 

Scope & Deliverables

• 510(k)/De Novo/PMA regulatory strategy & timelines

• PCCP design protocols, rollback criteria, validation requirements

• Label/claims guardrail frameworks (US & CA)

• ONC HTI-1 transparency language (where applicable)

• Dual US/CA clearance support

• Post-market monitoring & drift detection planning

 

Disclaimer: We provide regulatory strategy support; FDA and Health Canada make final clearance/approval determinations.

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3. Economics: Coding, Payment & Pricing/Contracting

Secure codes, align pricing, unlock paid claims.

 

Proof Points

• New/revised CPT/HCPCS code milestones achieved within designated AMA/CMS timelines*

• Margin improvements possible via optimized contracts and payer segmentation*

 

Scope & Deliverables

• Code dossier preparation and AMA calendar navigation

• Payment mapping: FFS, DRGs, site-of-service modeling

• Pricing & contracting strategies for commercial and employer payers

• IRR/rNPV bridge models linking access to forecasted ROI

• Provider education & HCP billing toolkits

 

Disclaimer: Coding and payment decisions are made by AMA, CMS, and payers. We provide strategic support but do not guarantee coverage, pricing, or payment determinations.

 

4. Go-to-Market, Sales & Lighthouse Pilots

Pilots that convert to policy and paid utilization.

 

Proof Points

• Reference sites often established within 8–12 weeks*

• Conversion to paid cases seen in 16–20 weeks in select engagements*

• Policy conversion signals typically visible within 6–9 months*

 

Scope & Deliverables

• Policy-aligned pilot design with endpoints tied to coverage criteria

• AMC/IDN/provincial KOL site targeting

• Dual US/CA launch sequencing

• Sales enablement packages (compliant HCP materials, objection handling)

• Pilot-to-policy data alignment

 

Disclaimer: Pilot conversion and utilization depend on provider adoption, patient response, and payer decisions. No guarantee of adoption is made.

 

5. Evidence, HEOR & Patient Support Programs

Real-world proof payers accept; PSP that scales.

 

Proof Points

• First-pass payer dossier acceptance achieved in prior submissions*

• PSP throughput and enrollment improved in representative client programs*

 

Scope & Deliverables

• RWE protocols, HEOR models, and budget impact analysis

• PSP workflow redesign: consent, enrollment, adherence

• Oncology screening pathway optimization

• Payer evidence packaging aligned to coverage decision factors

• Embedded privacy and safety governance

 

Disclaimer: Clinical and operational outcomes depend on patient engagement and provider participation. Payers independently determine evidentiary sufficiency.

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6. AI Integration & Imaging Partnerships

Put AI in workflow, EHR, FHIR, DICOM, so it gets used.

 

Proof Points

• Target-site integration timelines of 6–12 weeks achieved across select implementations*

• Latency and inference cost performance aligned with operational acceptance criteria*

 

Scope & Deliverables

• EHR/FHIR integration and interoperability development

• DICOM-native imaging workflows including routing & viewer integration

• Telemetry dashboards capturing latency, GPU efficiency, inference cost

• Channel/GPO/reseller partnership enablement packs

• Usability and validation studies supporting payer dossiers

 

Disclaimer: Integration outcomes depend on existing IT, workflow, and end-user adoption. No guarantee of utilization is made.

 

7. Clarity™ Fractional & BOT Commercial Leadership

Elastic field ops with compliant omnichannel execution.

 

Proof Points

• SLAs for content review reduced to <7 days in select accounts*

• Field-to-paid utilization rates improved under Clarity™ governance models*

 

Scope & Deliverables

• Interim VP/Head of Commercial leadership with defined KPIs

• Omnichannel campaign optimization under MLR/PAAB compliance

• KAM playbook and congress calendar execution

• Weekly Clarity™ reviews (performance bands, decision gates)

• Reporting impact on utilization and cost

 

Disclaimer: Outcomes depend on product–market fit and competitive positioning. We ensure compliance readiness but do not guarantee utilization outcomes.

 

8. Investor Readiness & Fund Raising

 rNPV/IRR scenario bands

 

Proof Points

• Term sheets secured following structured investor readiness programs*

• Reduced burn multiples achieved with financial telemetry dashboards*

 

Scope & Deliverables

• Investor-ready decks, data rooms, and access ladders

• P50/P90 rNPV valuation bridges & adoption milestones

• TCET/LCD landscape scans

• Board decision cadences, governance logs

• Financial trajectory models with runway optimization

 

Disclaimer: Capital raising outcomes depend on investor discretion and market readiness. No guarantee of investment is made.

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9. Investor Partnership & Commercial Due Diligence

Red-flag fast; 180-day value plan.

 

Proof Points

• IC memos produced in rapid turnaround for portfolio diligence*

• First-paid-claim roadmaps delivered during 180-day value plans*

 

Scope & Deliverables

• Pre-IC red-flag triage: coverage, coding, pricing gaps

• Policy & payer adoption ladders (US/CA)

• Unit economics testing + revenue realism

• 180-day growth plan + IC reporting packs

 

Disclaimer: Investment decisions are made solely by investors. Our assessments are strategic inputs and not guarantees of performance.

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10. IP & Moat Strategy (Patents, Data, Exclusivity)

Defend edges payers and rivals can’t erode.

 

Proof Points

• FTO analyses completed with mitigation pathways recommended*

• Patent whitespace analysis conducted across device/AI landscapes*

 

Scope & Deliverables

• Freedom-to-Operate (FTO) risk assessments

• Patent landscape analysis and whitespace ID

• Data exclusivity and regulatory moat strategy

• Trade secret protection + know-how management

• Competitive intelligence & surveillance

• IP portfolio optimization for monetization

 

Disclaimer: We provide strategic guidance. For formal patent filings or legal determinations on IP, seek qualified legal counsel.

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Overall Disclaimer (Global for Website)

All statements of expected timelines, coverage, payer adoption, or investor outcomes reflect representative past engagements where cited. Actual performance varies based on regulatory decisions, payer policies, provider adoption, patient behavior, and investor discretion. No warranties or guarantees of outcome are expressed or implied.

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