TAM (Total Addressable Market) is the total revenue opportunity if 100% of the market used the product. SAM (Serviceable Available Market) narrows to the segment the company can serve given regulatory, geographic, and product constraints. SOM (Serviceable Obtainable Market) is the realistic share over a defined timeframe. TAM is total demand, SAM is the part a company's product and channels can serve, and SOM is the share it can realistically win. Investors look for clear assumptions on patient counts, procedure volumes and pricing. Overly large TAM figures without a clear path to SOM weaken credibility.

Why it matters

Investors expect bottom-up TAM/SAM/SOM models. In MedTech, sizing must reflect procedure volumes, addressable indications, reimbursement constraints, and competitive dynamics.

Common pitfalls

•Top-down sizing ('1% of a $10B market') without unit economics is a red flag in any pitch.

Sources

a16z: market sizing · a16z
AdvaMed Code of Ethics · AdvaMed
AHRMM - Healthcare Supply Chain · AHRMM
SBA market research: demand, market size and pricing (supporting context) · SBA

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.