MedTech Launch Guide
    Education Hub for Founders
      Roadmap/01 · IP Protection02 · Regulatory Pathway03 · Clinical Evidence04 · Reimbursement05 · Cybersecurity06 · Business Model07 · Go-To-Market
    Step 06 of 7 · Roadmap

    Business Model

    Capital equipment, consumables, SaaS, or service - pick on purpose

    When to start
    Concurrent with regulatory pathway - before pricing decisions are made
    Duration
    Initial model: 1–2 months · Refined with payer/buyer evidence: 12+ months
    Indicative cost
    Internal - but the wrong choice can cost 50%+ of enterprise value at exit

    Business model selection determines your unit economics, the kind of investor who'll fund you, and the comparable companies your exit will be priced against. Most medtech founders default to a model without examining alternatives - and discover at Series B that the wrong choice has compounded.

    The five common archetypes

    Each has distinct gross margin, sales cycle, and investor base.

    • Capital equipment - high upfront price, long sales cycle, hospital capital committee approval
    • Razor + blade - equipment placed at low/zero cost, recurring consumables drive economics
    • Per-procedure / pay-per-use - usage-aligned billing, often through GPO/IDN contract
    • SaaMD subscription - software-as-a-medical-device with annual or monthly licensing
    • Service / pathology - internal device powering an outsourced clinical service line

    Match the model to the buyer

    Hospital capital committees evaluate equipment annually with 18-month budget cycles. Service-line directors approve consumables monthly. Health-system CIOs sign SaaS. Knowing who signs determines what you build - and how you price it.

    Build a defensible moat

    FDA clearance is a moat for ~24 months. Long-term defensibility comes from data network effects, clinical workflow integration, GPO contracts, or installed-base lock-in. Identify yours before Series B - investors will ask.

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    Cybersecurity
    Step 05 · FD&C Act §524B - premarket package + lifelong postmarket plan
    Next
    Go-To-Market
    Step 07 · KOLs, IDN selling, GPO contracting, and the chasm in between