Acronyms, abbreviations and definitions of medtech terms, devices and companies
[Illustration by wladimir1804 via Adobe Stock]
Medtech’s a complicated business, with its own industry abbreviations, acronyms and terms. Cut through the jargon with our constantly evolving glossary — and please suggest additions by emailing Managing Editor Jim Hammerand.
3D printing: A type of additive manufacturing used to make patient-specific anatomical models, device prototypes and finished medical devices.
510(k): FDA clearance under Section 510(k) of the Food, Drug and Cosmetic Act authorizes a company to sell a Class I, II, or III medical device based on substantially equivalent predicate devices
AbbVie: This Abbott pharma spinoff gets its name from its former parent company — one of the world’s largest medical device companies — and “vie,” which Abbott said references the Latin root “vi” meaning “life.
ADA: The American Diabetes Association’s annual scientific sessions meeting is referred to as ADA.
AdvaMed: The Advanced Medical Technology Association, an organization that represents medical device makers
AFib: Atrial fibrillation is an irregular heart rhythm (arrhythmia) with a rapid heartbeat (tachycardia) that may be temporary or permanent. A variety of devices monitor, detect, diagnose and treat AFib, which is associated with cardiac complications such as heart failure and stroke.
AI: Artificial intelligence in medtech is exploding as device developers — including developers of algorithms and software-as-a-medical-device — find new or improved methods for diagnosis, patient monitoring, procedures and more efficient workflows.
BD: Becton, Dickinson and Co. is one of the world’s largest medical device manufacturers.
BCI: Brain-computer interface systems monitor and collect brain signals (usually with an electrode brain implant) to relay commands for patients who have lost neuromuscular functions.
CAD: Coronary artery disease
CAPA: Corrective and preventive action
CDMO: Contract development and manufacturing organization, a third-party outsourcing partner that designs and makes medical devices or components for medtech developers and OEMs
CD: Chlorine dioxide (ClO₂) is a gas used to sterilize medical devices.
CDRH: The FDA Center for Devices and Radiological Health reviews medical devices and radiation-emitting products.
CGM: Continuous glucose monitor, used for diabetes
Class I, II and III: The FDA uses three class levels to categorize the risk level of devices and recall. However, while a Class I recall is the most dangerous and a Class III recall the least dangerous, a Class I device is considered the lowest risk for patient health while Class III devices pose the greatest risk and are subject to the most regulatory oversight.
CMO: Contract manufacturing organization, a third-party outsourcing partner that makes components or devices for medtech developers and OEMs. CMO is also an abbreviation for two executive titles in a medical device company’s management: chief medical officer and chief marketing officer.
Combination products/devices: These medical products use a combination of drugs, devices, and/or biological products for therapies and diagnostics. Examples include pre-filled drug syringes, antibiotic-coated implants, inhalers and microneedle patches.
Complaint files: The FDA requires medical device manufacturers to retain files of all complaints and establish and maintain procedures for receiving, reviewing, and evaluating complaints.
CRO: Contract research organization, a third party that provides medical device developers and manufacturers with outsourced research services
De novo: De novo classification from the FDA allows a medical device company to market a novel Class I or II device.
DHF: A design history file is a compilation of records describing the design history of a finished device. The FDA requires medical device manufacturers maintain this information.
DHR: A device history record is a compilation of records containing the production history of a finished device. The FDA requires medical device manufacturers maintain this information.
DMR: A device master record is a compilation of records containing the procedures and specifications for a finished device. The FDA requires medical device manufacturers maintain this information.
ECG/EKG: Electrocardiogram, a device for monitoring and recording heart signals
Electron-beam sterilization: Also called e-beam sterilization, this is one of the fastest-growing methods of sterilizing medical devices.
Embecta: The name of this BD diabetes care business spinoff includes “em” for empathy for those living with diabetes, and “bect” for former parent company Becton, Dickinson & Co.
ESG: Environmental, social and governance, a corporate function focused on sustainability, ethics and decision-making
EtO: Ethylene oxide is a gas used to sterilize around half of all medical devices.
FAERS: The FDA Adverse Event Reporting System is a database of adverse event reports, medication error reports and product quality complaints submitted to FDA.
FDA: The U.S. Food & Drug Administration
Human factors: This element of medical device design and engineering considers how physicians, patients, caregivers and other users interact with a particular product to ensure it works safely and intuitively.
HUD: Humanitarian use device designation is an FDA approval pathway for medical devices that may help people with rare diseases or conditions, defined as those affecting no more than 8,000 people in the U.S. per year.
IDE: Investigational device exemption from the FDA permits the use of an investigational device in a clinical study to collect data on the product’s safety and effectiveness.
IFU: Instructions for use tell a patient or caregiver how to use a device, including set-up, operation, cleaning, troubleshooting and storage.
IVD: In vitro diagnostic
IVL: Intravascular lithotripsy is a way to treat arterial calcification with sonic pressure waves.
J&J: Johnson & Johnson is the world’s second-largest medical device company through its Johnson & Johnson MedTech unit, formerly Johnson & Johnson Medical Devices.
MDUFA: Medical Device User Fee Amendments allow the FDA to collect fees from medical device manufacturers to fund device review and regulation.
Medtech: Medical technology
Medical Device Regulation: The European Union’s Medical Device Regulation is commonly abbreviated as MDR.
Medical Device Reporting: MDR is one of the FDA’s tools to monitor medical device performance and safety issues.
Medtronic: The world’s largest medical device company by revenue was founded in 1949 as a medical electronics repair business.
Nitinol: A nickel-titanium alloy with shape memory properties that make it useful in many medtech applications.
OEM: Original equipment manufacturer is an entity such as Medtronic that makes its own components or devices, versus a CMO that manufactures those products on behalf of an OEM.
PAD: Peripheral artery disease
PMA: Premarket approval is the FDA’s review process for Class III medical devices, which are those that support or sustain life, are substantially important in preventing health impairment or pose the greatest risk of serious injury or death.
Postmarket surveillance: Defined by the FDA as “the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.”
QMS/QS/QSR: A medical device manufacturer’s quality management system (QMS), quality system (QS) and quality system record (QSR) are all regulated by the FDA, which requires all medical device manufacturers to maintain a QSR.
RDN: Renal denervation is a treatment for hypertension that applies electricity to deactivate nerves in the arteries that carry blood to the kidneys. Renal denervation systems have won approval in the E.U., but not in the U.S.
R&D: Research and development (see the top medtech R&D spenders here)
SaMD: Software-as-a-medical-device is software with a medical purpose that’s not part of a physical medical device.
SCG: Seismocardiogram, a device for monitoring and recording heart vibrations
TCET: Transitional Coverage for Emerging Technologies, a new pathway proposal for Medicare coverage of breakthrough devices
TCT: The Transcatheter Cardiovascular Therapeutics conference is the annual meeting of the Cardiovascular Research Foundation (CRF) for interventional cardiovascular medicine.
TAVR: Transcatheter aortic valve replacement is a minimally invasive procedure to replace a heart valve with an implant delivered by catheter rather than open-heart surgery.
UDI: Unique device identifier, required by the FDA on medical devices to track each individual unit from manufacturing through distribution and use
ZB: Zimmer Biomet is one of the world’s largest medical device companies and the third-largest orthopedics manufacturer.
ZimVie: The name of Zimmer Biomet’s spine and dental businesses spinoff is a combination of “Zim” from its former parent company and “Vie,” the French word for “life.” ZimVie is one of the world’s largest medical device manufacturers.
