Runway is cash on hand divided by net monthly burn. It tells founders and boards how long the company can operate before needing more capital or reaching profitability. Runway projections should use realistic burn forecasts that include planned hires, trials and regulatory fees. Because device programs have long timelines, companies often target 18 to 24 months of runway after each round. When runway falls below about 12 months, many boards start fundraising or cost planning.

Why it matters

MedTech investors typically expect 18–24 months of runway after a round to reach the next value-creating milestone (e.g., trial readout, regulatory clearance). Burning through a round in 12 months without a milestone is a red flag.

Common pitfalls

•Confusing gross burn with net burn; revenue-stage companies should track both.
•Not stress-testing runway against trial enrollment delays or FDA RTA letters.

Sources

NVCA Model Documents · NVCA
Silicon Valley Bank - Healthcare Reports · SVB
PitchBook - MedTech Coverage · PitchBook
SEC Ready to Raise CAPITAL: calculating runway · SEC

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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.