Burn rate is the net monthly cash outflow; runway is cash on hand divided by burn rate, indicating how long a company can operate without additional financing or revenue. Boards track both numbers monthly and usually expect a financing to start when 9 to 12 months of runway remain, because MedTech rounds can take six months or more to close. Runway should be modeled against regulatory and clinical timelines, not just calendar months. Common levers to extend it include cutting nonessential spend, staging programs and adding non-dilutive funding.

Why it matters

MedTech runway planning typically targets 18–24 months to reach the next value-inflection milestone (clearance, clinical readout, reimbursement decision) before re-financing.

Common pitfalls

•Underestimating the financial resources required to achieve regulatory milestones, such as obtaining FDA clearance or CE Mark, can lead to project delays or failure.
•Failing to allocate sufficient budget for ongoing quality system maintenance, post-market surveillance, and potential regulatory audits can result in non-compliance.
•Ignoring the financial impact of unexpected regulatory inquiries, Notified Body audits, or product recalls can deplete a company's runway prematurely.
•Assuming that initial regulatory approvals guarantee continuous market access without considering the costs of maintaining compliance in a dynamic regulatory landscape is a common oversight.
•Lack of financial planning can jeopardize a company's ability to implement corrective and preventive actions (CAPAs) effectively, impacting patient safety and regulatory standing.

Sources

Silicon Valley Bank Healthcare Reports · SVB
PitchBook - MedTech Coverage · PitchBook
NVCA Model Documents · NVCA
SEC capital-raising glossary: burn rate · SEC
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

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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.