All MedTech Terms
513 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.
Showing 1–23 of 23
AdvaMed Code of Ethics
Industry code governing interactions between U.S. medical-device companies and healthcare professionals.
Advisory Board
Convening of external experts to advise on strategy or product.
Anti-Kickback Statute(AKS)
U.S. criminal statute prohibiting remuneration to induce federal healthcare business.
Bottom-Up Market Sizing
Building market size from procedure volumes × price × penetration.
Distributor vs Direct Sales
Choice between selling through third-party distributors or hiring a direct salesforce.
Field Clinical Engineer(FCE)
Manufacturer representative providing clinical and technical support in the OR or cath lab.
Freedom to Operate(FTO)
Analysis of whether a product can be sold without infringing third-party IP.
Good Clinical Practice(GCP)
International quality standard for designing and conducting clinical trials.
Group Purchasing Organization(GPO)
Entity that aggregates hospital purchasing to negotiate prices with suppliers.
Integrated Delivery Network(IDN)
Network of healthcare facilities under common ownership or affiliation.
Key Opinion Leader(KOL)
Influential clinician who shapes peer practice and adoption.
Label Claims
Statements about a medical device's purpose, performance or benefits, subject to applicable labeling and intended-use requirements.
Launch Readiness
Cross-functional checklist confirming a product is ready for commercial release.
Managed Service / Reagent Rental
Multi-year contract where instrument cost is bundled into per-test pricing.
Off-Label Use
Use of a device for an indication not in its cleared/approved labeling.
Physician Payments Sunshine Act
U.S. law requiring disclosure of payments to physicians and teaching hospitals.
Physician Training and Proctoring
Structured education and supervised cases for physicians adopting a new device.
Pre-Submission Meeting(Q-Sub)
Formal FDA feedback request prior to a marketing or IDE submission.
Razor / Razor-Blade Model
Sell capital equipment at low margin; recurring consumables drive profit.
Stark Law
Federal law restricting physician self-referral for designated health services.
Strategic Acquisition
Purchase of a company by a strategic buyer, typically a larger MedTech.
TAM / SAM / SOM
Market sizing framework: total, serviceable available, and serviceable obtainable.
Value Analysis Committee(VAC)
Hospital cross-functional committee that reviews and approves new product purchases.