GLOSSARY

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I

Term Definition
IACUC (Institutional Animal Care and Use

A committee that institutions must establish in order to oversee and evaluate animals used for trials.

ICD-9 (International Classification of D

International Classification of Diseases, 9th edition; codes for classifying patient diagnoses.

ICD-9-CM (International Classification o

International Classification of Diseases, 9th edition - Clinical Modification; codes for classifying morbidity data and describing patient diagnoses and procedures; variation on ICD-9 used by the U.S.

IDE (Investigational Device Exemption)

An exemption to a hospital or doctor from the FDA that allows the hospital or doctor to use a device prior to its regulatory approval, usually as part of a trial.

IDN (Integrated Delivery Networks)

An organization that aggregates hospitals, physicians, allied health professionals, clinics, outpatient facilities, home care providers, managed care, and suppliers into a single, closed network.

IFU (Indications for Use)

Instructions on how to use a device, typically a package insert.

Illiquid

Not liquid. E.g., stock or other property that is not easily sold or converted to cash.

Indirect sales model

A sales and distribution agreement with an existing distributor, or forming a third-party partnership with another manufacturer.

Information rights

Section of a term sheet that defines what and how much information about the company is shared with investors.

Informed consent

Consent by a research subject that indicates they are fully aware of all aspects of the trial prior to participating, including both the risks and potential benefits.

Injunction

An order issued by the courts that requires a medical device company to refrain from some action (manufacturing, selling, etc.)

Innovation notebook

A notebook in which an innovator documents each aspect of the invention; this notebook may be used in infringement trials to prove inventorship.

Intention to treat

Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized (see Randomization), even if they never received the treatment when they were supposed to or ended up receiving the treatment when they were not supposed to.

Intrapreneur

A person within a company who is tasked to develop new products or business models - an internal entrepreneur.

IPO (initial public offering)

The first offering of a company's stock for public sale in a stock exchange such as the New York or London Stock Exchange.

IRB (Institutional Review Board)

Institutional Review Board; a committee that monitors clinical trials to ensure the safety of human subjects.

ISA (International Searching Authority)

The organization that performs patent searches as part of an international patent filing.

ISO (International Organization for Stan

A non-governmental network of national standards institutes that establishes standards of quality. The name ISO is not an acronym but rather based on the Greek word isos meaning equal.

ISO 13485(International Standards Organi

European Union's Quality System; compare QSR.

ISO 9001

A quality certification in use around the world between the 1980s and 1990s.

IVDMD (In Vitro Diagnostic Med Dev Dir)

In Vitro Diagnostic Medical Device Directive 98/79/EEC; one of three regulatory approval directives used in the EU.

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