GLOSSARY
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. |