ebiodesign

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

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

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

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

High-profile practitioners who are influential with their colleagues.

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

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

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

A literature database of biomedical research papers.

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

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

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

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

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.

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

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.

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

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.

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

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

The difference between income and the expense incurred during operations.

The opportunity forgone by choosing a different opportunity.

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

The office within a university that manages its IP assets.

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