Acronyms, abbreviations and definitions of medtech terms, devices and companies
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 byemailing Managing Editor Jim Hammerand.亚博高登棋牌: A type ofadditive manufacturing使用to makepatient-specific anatomical models, device prototypes and finished medical devices.
3TG: This is an abbreviation for tantalum, tin, tungsten and gold, which are some of the most commonly usedconflict mineralsin medical device manufacturing.
510(k): FDAclearance 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: TheAmerican Diabetes Association’s annual scientific sessions meetingis referred to as ADA.
AdvaMed: TheAdvanced Medical Technology Association, an organization that represents medical device makers
AFib:Atrial fibrillationis 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 asheart failureandstroke.
AI:Artificial intelligence in medtechis 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.
Association of Medical Device Reprocessors: TheAMDRrepresents organizations engaged in commercial reprocessing and remanufacturing of medical devices for re-use.
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 agas used to sterilize medical devices.
CDRH: TheFDA Center for Devices and Radiological Health地中海的评论ical devices and radiation-emitting products.
CGM:Continuous glucose monitor,使用for diabetes
Class I, II and III: The FDA uses three class levels to categorize the risk level of devices and recall. However, while aClass I recall is the most dangerous and a Class III recall the least dangerous, aClass 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:88亚博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.Examplesinclude 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 classificationfrom 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 callede-beam sterilization, this is one of the fastest-growing methods of sterilizing medical devices.
Embecta: Thename of this BD diabetes care business spinoffincludes “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 oxideis a gas used to sterilize around half of all medical devices.
FAERS: TheFDA Adverse Event Reporting Systemis a database of adverse event reports, medication error reports and product quality complaints submitted to FDA.
FDA: The U.S.Food & Drug Administration
FMEA: Failure Mode and Effect Analysis proactively identifies and addresses potential problems with a medical device before they arise to mitigate those failures.
Harmonization by Doing: HBD is a collaboration between the FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to expedite medical device approvals in both countries.
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 designationis 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 exemptionfrom 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 usetell a patient or caregiver how to use a device, including set-up, operation, cleaning, troubleshooting and storage.
IVDR: The European Commission’s In Vitro Diagnostics Regulation
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 companythrough its Johnson & Johnson MedTech unit,formerly Johnson & Johnson Medical Devices.
MDUFA: Medical Device User Fee Amendments allow the FDA tocollect fees from medical device manufacturers to fund device review and regulation.
Medtech: Medical technology
Medical Device Regulation: The European Union’sMedical Device Regulationis commonly abbreviated as MDR.
Medical Device Reporting:MDRis one of the FDA’s tools to monitor medical device performance and safety issues.
Medtronic: Theworld’s largest medical device company by revenuewas founded in 1949 as a medical electronics repair business.
Nitinol: Anickel-titanium alloy with shape memory properties that make it useful in many medtech applications.
OEM:Original equipment manufactureris 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 approvalis 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.
PMDA: The Pharmaceuticals and Medical Devices Agency is Japan’s version of the FDA.
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’squality 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适用于电力在t禁用神经he 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 thetop medtech R&D spenders here)
Reprocessing: A process for cleaning and disinfecting or sterilizing medical devices for re-use, including certain single-use devices under FDA standards.
RWD: Real-world data isdefined by FDAas “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWD sources include electronic health records, medical claims, product or disease registries, and digital health technologies such as apps or smart sensors.
RWE: Real-world evidence is clinical evidence of a device’s safety and/or effectiveness collected derived from analysis of real-world data (RWD).
SaMD:Software-as-a-medical-deviceis software with a medical purpose that’s not part of a physical medical device.
SCD: TheSelective Cytopheretic Deviceis made by SeaStar Medical for extracorporeal therapy to treat hyperinflammation.
SCG:Seismocardiogram, a device for monitoring and recording heart vibrations
TCET: Transitional Coverage for Emerging Technologies, a newpathway 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:经导管主动脉瓣置换术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 theworld’s largest medical device companiesand the第三大骨科制造商.
ZimVie: The name of Zimmer Biomet’s spine and dental businesses spinoff is acombination of “Zim” from its former parent company and “Vie,” the French word for “life.” ZimVie is one of theworld’s largest medical device manufacturers.
This post was originally published in July 2023 and was updated with new entries in August 2023.
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