Market Pathway & Submission Software · Strategizer
From feasibility to market strategy — fully researched.
A clear picture of every pathway and every market.
Conduct detailed research for each idea and market. Find predicate devices or equivalents. Analyze financials, lead time, and business opportunity — so every go-to-market decision is grounded in evidence, not assumption.
From feasibility to market — one platform.
The decisions that determine whether a product reaches market, and how fast, happen long before regulatory submissions are filed. Strategizer pulls together the data from hundreds of sources — device databases, patent records, regulatory histories, payer coverage data, country regulatory landscapes — and delivers the analysis that drives those decisions.
Feasibility & Competitive Research
Know the landscape before you commit resources.
Market feasibility analysis drawing on cleared device history, competitor filings, patent landscape, and clinical evidence. Understand what has cleared, who is filing, and what the competitive regulatory environment looks like for your product category — before the product definition is locked.
Country Entry Analysis
Every market you're considering, assessed in full.
Regulatory requirements, expected timelines, data package requirements, and approval complexity for every country on your target list. Draws on Synthesis's Atlas and Crossmap engines for continuously-updated country regulatory intelligence. Built for the team deciding which markets to enter, in what order, and on what timeline.
Financial Analysis & Timelines
Executive-ready outputs, not database query results.
Regulatory timeline modeling, cost-of-compliance estimates per market, and financial projections prepared automatically. Strategizer's AI generates ready-to-present analysis that gives leadership the context to make go/no-go decisions — without weeks of manual research and slide preparation.
Pathway & Classification
The right regulatory pathway — determined, not guessed.
Device classification, pathway determination, and predicate chain identification — all three delivered together, with the evidence and rationale behind each recommendation. Covers 510(k), PMA, De Novo, and international equivalent pathways across all major markets.
Reimbursement & Commercialization
Regulatory approval is one milestone. Reimbursement is another.
Payer coverage landscape, HTA body requirements, and CPT code analysis surfaced alongside the regulatory strategy. Understand the full path from regulatory clearance to commercial viability — including the reimbursement hurdles that can be as consequential as the regulatory ones.
Project Timelines
From regulatory strategy to project plan.
End-to-end regulatory timeline modeling from feasibility through submission and approval — by pathway, by country, with milestone dependencies mapped. Gives project teams and leadership a realistic picture of what the path to market actually looks like.
Why teams choose Strategizer.
Data from hundreds of sources
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Countries, devices, patents, clinical data, payer records — aggregated and cross-referenced so your team doesn't spend weeks doing it manually.
Decisions faster
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Analysis that would take a regulatory team weeks to assemble is prepared automatically — so leadership can make go/no-go calls with confidence, not uncertainty.
Presentation-ready output
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AI-generated analysis formatted for executive review — not a database export. Your team walks out with a deck, not a spreadsheet.