GLOSSARY

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Term Definition
Liquidity event

The transaction that enables an investor to receive cash in exchange for its equity stake in a company. Also referred to as exit events.

LLC (Limited Liability Company)

A type of corporation that establishes a board and limits liability to the owners of the company.

Longitudinal data

Data collected in studies that take place over several years, often decades or more.

Loss leader

An item sold at a lower cost (often below the cost to the manufacturer) in order to stimulate additional sales of profitable items.

Management controls

One subsystem of a Quality Management system; Controls that ensure adequate management support for Quality Systems.

Manufacturing costs

Costs for material (COGS), manufacturing labor, facilities and equipment.

Market segmentation

Using specific parameters to partition the market into identifiable, homogeneous segments in order to understand sales and marketing needs.

Market withdrawal

A response to a minor violation that is not caused by legal action by the FDA.

Marquee physicians

High-profile practitioners who are influential with their colleagues.

Materials controls

One subsystem of a Quality Management system; Controls that ensure material quality and consistency.

MAUDE

The FDA database of all significant adverse events due to medical devices.

MDD (Medical Device Directives)

Medical Device Directives 93/42/EEC; one of three regulatory approval directives used in the European Union.

MDR (Medical Device Reporting)

The reporting vehicle through which the FDA receives information about significant medical device adverse events that was established by the Safe Medical Devices Act.

MDUFMA (Medical Device User Fee and Mode

The federal act that established user fees in the medtech industry.

Me-too products

Products that are relatively undifferentiated from products that are already on the market.

Mechanism of action

The specific biochemical or biomechanical interaction through which a drug or device produces its effect.

MEDLINE (Medical Literature Analysis and

A literature database of biomedical research papers.

Medtech

Medical Device Technology. A short form to allow comparisons to Biotech, for instance.

MEPS (Medical Expenditures Panel Survey)

The longitudinal data on health expenditures of 30,000 US households provided by AHRQ.

Mezzanine funding

Funding that is required when some of the most significant risks have been resolved but the company has yet to generate sufficient revenue to be self-sustaining.

MHRA (Medicines and Healthcare Products

The organization that approves devices and drugs for Europe (including UK).

Mixed need

A need that has features that are easily achievable (more incremental to existing approaches) and other elements that introduce significant technical or clinical risk.

Morbidity

When a human is harmed in some way (short of death) - infection, decreased quality of life, extended hospital stay, physical impairment, etc.

NAI (No Action Indicated)

A classification for an FDA audit that indicates that no further action is required by the inventor or company in order to seek approval for a device.

NCD (National coverage determination)

One of two types of reimbursement determinations made by Medicare that provides guidance on national reimbursement coverage. Typically applies to payments for inpatient services.

NCHS (National Center for Health Statist

The US-based principal health statistics agency; they compile statistical information to guide actions and policies to improve health.

NDA (Non-Disclosure Agreement)

An agreement between two parties such that the party receiving confidential information from another party will not disclose the information to anyone for a fixed period of time.

Niche strategy

A strategy whereby a company seeks to own the customer relationships in a specific, focused area of medicine.

Non-exclusive agreement

Agreements where both parties are free to enter into agreements with other companies.

Non-exclusive license

A license that allows the licensee rights of use within a given field and within whatever other limitations are provided by the license, but allows the licensor to grant similar rights to other parties.

Non-governmental organizations

Non-profit organizations that are often working for a cause. These organizations provide resources and assistance to parties when those parties’ own or other governments will not or cannot.

Notice of Allowance

The notice from the USPTO to indicate the patent has been accepted.

NSE (Not Substantially Equivalent)

A determination by the FDA that a new device is not equivalent enough to a predicate device and therefore cannot use the 510k pathway.

OAI (Official Action Indicated)

A classification for an FDA audit that indicates that action is required by the inventor or company in order to seek approval for a device.

Observational Studies

Studies that make conclusions about the efficacy of a treatment or device on a group of subjects where the assignment of subjects into the treated versus control groups is outside the control of the investigator.

OCP (Office of Combination Products)

Office of Combination Products; the section of the FDA that reviews medical technology that is a combination of drugs and device or drugs and biologics to determine which center of the FDA will regulate it.

OEM (Original Equipment Manufacturer) st

When a company provides technology and/or components to another company that then assembles and sells the finished product.

Off-Label use

The use of a treatment for conditions other than those approved by the FDA.

Office action

A document issued by the USPTO that outlines objections or necessary changes to an application or claim due to finding prior art.

OIPE (Office of Initial Patent Examinati

The first agency that examines patent applications for completeness.

Operating profit

The difference between income and the expense incurred during operations.

OpEx (operating expenses)

Costs considered not to be manufacturing costs, including R&D, sales staff, general and administrative functions, and non-production facilities costs.

Opportunity cost

The opportunity forgone by choosing a different opportunity.

OPRR (Office for Protection from Researc

Office for Protection from Research Risks; now called the Office for Human Research Protections.

Option pool

The total number of stock options available for a company to grant, typically to employees.

OTC (Over the Counter)

Drugs or devices that are sold directly to the end consumer.

OTL (office of technology licensing)

The office within a university that manages its IP assets.

OUS (Outside United States)

Refers to clinical trials that are performed outside the US. Used in reference to obtaining regulatory approval.

P&PC (Production & Process Controls)

One subsystem of a Quality Management system; requires that production processes be controlled and monitored to ensure product conforms to specifications.

Partnering strategy

One option in getting an idea to market - joining with another company to help develop a device.

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