GLOSSARY

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M

Term Definition
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.

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.

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.

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