Bottom-up sizing builds TAM from defensible inputs - incidence/prevalence, procedure volumes, addressable subset, average selling price, and realistic penetration curves - rather than top-down market percentages. Bottom-up sizing multiplies patients or procedures by expected adoption and price, often by site of care. It is more credible than top-down estimates from industry reports. Inputs should be backed by claims data, registries or published epidemiology.

Why it matters

Preferred by sophisticated MedTech investors. Inputs are sourced from registries (NCDR, STS), claims (HCUP, Medicare 5%/100%), and society reports.

Common pitfalls

•Confusing revenue projections with market size, leading to an inflated sense of opportunity.
•Underestimating the burden of evidence required to support incidence and prevalence data, especially when extrapolating from limited sources.
•Failing to account for competitive landscapes and alternative treatments, which can significantly impact market penetration.
•Overlooking the dynamic nature of healthcare, including policy changes, technological advancements, and shifting clinical practices.
•Not adequately documenting the assumptions and data sources used, making the market size difficult to defend or update.

Sources

HCUP · AHRQ HCUP
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.