GLOSSARY

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Term Definition
483

A form letter issued by the FDA if actionable problems are uncovered during an FDA audit.

510k

One of several pathways for medical devices through the regulatory process at the FDA. This pathway is used when similar devices are already in use.

Acquisition

A transaction in which the seller of the property (technology, IP, company) completely relinquishes control of the property to the acquirer.

Administrative detention

A temporary "cease and desist" order from the FDA.

AdvaMed (Advanced Medical Technology Ass

The advocacy group for medical device companies.

AHA (American Hospital Association)

An association that represents hospitals, healthcare networks and their patients and communities.

AHRQ (Agency for Healthcare Research and

U.S. Government agency responsible for collecting evidence-based data on health care outcomes. Longitudinal data is available through their website.

AIMDD (Active Implantable Medical Device

Active Implantable Medical Device Directive 90/385/EEC; one of the key regulatory approval directives used in the European Union.

AMA (American Medical Association)

The primary association of physicians in the United States; the AMA controls the issuance of new CPT Codes.

Angel investor

Experienced individual investors who use their own wealth to fund start-up companies. Angel investors may be organized in groups.

ANSI (American National Standards Instit

The US standards organization that is representative to ISO.

APC (Ambulatory Payment Classification)

Codes for classifying hospital outpatient procedures

Arm

Any of the treatment groups in a randomized trial. Most randomized trials have two “arms,” but some have three “arms,” or even more (see Randomized Trial).

ASIC (Application Specific Integrated Ci

One potential component of the electrical circuitry of a device.

ASQ (American Society of Quality)

American Society of Quality.

BATNA (best alternative to a negotiated

The course of action that will be taken if a negotiation fails to lead to an agreement.

BCBS (Blue Cross Blue Shield)

Health plans that operate in various regions in the US. There are 39 BCBS plans and the BCBS Association is a trade group that, among other things, helps establish guideline for reimbursement.

Bench testing

Testing prototypes (materials, methods, functionality) in a controlled laboratory environment (not in animals or humans).

Beneficence

A basic principle of bioethics that all medical work is for the good of the patient; contrast to malfeasance.

Bias

When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, blinding and randomization control bias.

Biocompatibility

The property of a material that indicates that it is compatible with being placed in humans.

Blind trial

A trial in which neither the members of the patient group nor any participating doctors, nurses or data analysts, are aware of which treatment or control group the patients are in.

Blue-Sky need

A large-scale need that would require major new medical or scientific breakthroughs and/or significant changes in practice.

Bottom-up model

A sales forecast model that uses a series of detailed sales factors, including sales cycle, adoption curve, hiring effort, commercial effort, etc. to predict future sales.

Breadboard

A board which can be used to assemble electronic components and connect them for use in prototyping devices with computer parts.

Bridge loan

An interim debt financing option available to individuals and companies which can be arranged relatively quickly and span the period of time before additional financing can be obtained.

Budget impact model

A model for demonstrating product value that examines the cost and treatable population within a health plan, as well as the expected annual cost to the plan for covering a device.

Bundled pricing

Setting a single price for a combination of products and/or services.

CAB (Conformity Assessment Body)

The body that determines compliance to ISO 13485.

CAC (Carrier Advisory Committees)

The committee that performs a review of all local coverage decisions through Medicare.

CAF (contracting administration fee)

The fee that a Global Purchasing Organization will charge for managing the purchasing contracts for many end users, paid by the manufacturer.

CAGR (compound annual growth rate)

The annual growth rate for an investment.

CAPA (Corrective and Preventive Actions)

Corrective and Preventive Actions; One subsystem of a Quality Management system; the system to implement corrections upon and to avoid future problems in quality control.

Capability-based advantages

A company's advantage over competitors that is driven by a company’s capabilities. They are based on the ability to do something better or less expensively than the competition and/or customers.

Case controlled study

A study that compares outcomes of a group of patients treated with a new device or procedure to a matched group receiving no treatment (or a standard treatment).

Cash flow Statement

An accounting statement that shows the cash that flows in the company in each period (typically quarter) minus the cash that flows out in the same period.

CBER (Center for Biologics Evaluation &

Center for Biologics Evaluation & Research; the part of the FDA that approves biologics.

CDER (Center for Drug Evaluation & Resea

Center for Drug Evaluation & Research; the part of the FDA that approves drugs.

CDRH (Center for Device and Radiological

Center for Device and Radiological Health; The center within the FDA (Food & Drug Administration) responsible for medical device regulation.

CE Mark

Resulting 'mark' that is given to a device in the EU to indicate regulatory approval.

Citation

A formal warning to a company from the FDA; prosecution will follow if changes are not made.

Civil Penalties

Monetary penalties imposed on a company after a hearing for violations.

Class I

Classification of a medical device by FDA that indicates low risk to a person.

Class II

Classification of a medical device by FDA that indicates intermediate risk to a person; devices are more complicated than Class I but non-invasive.

Class III

Classification of a medical device by FDA that indicates highest risk to a person; devices are typically invasive or life sustaining.

Clinical investigator

A medical researcher in charge of carrying out a clinical trial's protocol.

Clinical Study Protocol

A study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.

Clinical Trial

A research study performed to answer specific questions about diagnoses or therapies, including devices, or new ways of using known treatments. Clinical trials are used to determine whether new treatments are both safe and effective.

CME (Continuing Medical Education)

Additional training required to maintain a license for physicians and others in healthcare-related fields.

CMS (Centers for Medicare and Medicaid S

The primary government payer of health care charges for the elderly and disabled in the US.

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