GLOSSARY

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Term Definition
Exclusion criteria

Characteristics or contraindications that eliminate subjects from participating in a clinical study.

Exclusionary rights

The rights of the inventor or group of inventors, who has/ve been issued a patent on an invention, to be the sole person(s) creating and marketing that invention.

Exclusive agreement

Agreements that may limit the company with a given technology from sharing it with any other firms (thereby giving the licensor a strong positional advantage). In turn, the licensor may or may not agree to use only this one technology and not seek alternative suppliers.

Exclusive license

A license that grants only the licensee (and not even the licensor) the right to use a technology.

Exit event

When a company is either acquired or has an IPO.

Expansion funding

Funding required to ensure completion of clinical trials, initiation of additional trials or initial product launch. Such funding is often acquired through VCs or corporate investment.

Fast follower

A company that leverages its own corporate advantages to quickly capture market share from the first mover.

Field of use

A licensing option that allows an existing patented device to be used within a restricted domain, such as one clinical area.

FIM (First-In-Man)

First-In-Man; the first time a device or technology is used in a human subject.

Financial model

A detailed numerical articulation of a company's costs and revenue over time. It tracks both the cost of developing the innovation and bringing it to the market as well as market revenue and it follows these costs and revenue over a period of five to seven years.

First mover strategy

An attempt by a company to be first to market with any innovation.

Flow of money analysis

Analysis, aimed at identifying key stakeholders, that is focused on payments to providers of health care services.

Freedom to operate

The ability to commercialize a product, without infringing on the intellectual property rights of others.

Fully burdened cost

The total cost of an employee, including salary, benefits, associated overhead, and fees.

Gainsharing

When hospitals negotiate reduced prices with certain manufacturers in exchange for increased volume.

GCP (Good Clinical Practice)

Good Clinical Practice; guidelines from the FDA that outline specific standards for holding clinical trials.

GLP (Good Laboratory Practice)

Good Laboratory Practice; a system of management controls for laboratories that assures consistent and reliable results.

GMP (Good Manufacturing Practice)

Good Manufacturing Practice; formerly used by the FDA to promote quality; replaced by Quality Systems Regulation (QSR).

GPO (Global Purchasing Organization)

Global Purchasing Organization; An organization that brings together multiple hospital groups, large clinics, and medical practices into buying cooperatives.

HCPCS Level II (Health Care Financing Ad

Health Care Financing Administration's Common Procedure Coding System Level II; coding for supplies and services obtained outside the physician office that are not covered by a CPT or APC code.

HCUP net (Healthcare Cost and Utilizatio

A website with data about Healthcare Cost and Utilization Project - statistics on hospital stays at national, regional and state level; pronounced "hiccough net"

HDE (Humanitarian Device Exemption)

An exemption to the normal regulatory pathways for a medical device that is intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the U.S. per year.

Health Insurance Portability and Account

(HIPAA) An act of the U.S. Congress passed in 1996 that protects health insurance coverage when workers lose or change jobs. Also includes privacy and security protections for a patient's protected health information(PHI).

Hypothesis

A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.

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.

JAMA (Journal of the Amer Medical Assoc)

One of the premier medical journals in the United States.

KOL (Key Opinion Leaders)

Physicians and others in the Medical Device arena who are often consulted when new devices are readying for the market.

LCD (Local coverage determination)

One of two types of reimbursement determinations made by Medicare that provides guidance on national reimbursement coverage. Typically applies to payments for outpatient services. LCDs are decisions made by one of 28 Medicare contractors and apply only to the contractors’ area of coverage.

Lexicographer

An inventor may use his/her own language and definitions in a patent application, thus becoming a lexicographer.

Licensing

One option in getting a technology to market by transferring the rights to the technology from the innovator to a licensee in exchange for ongoing royalties and/or other payments.

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