GLOSSARY

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Term Definition
Reimbursement dossier

A set of documents that describe all aspects of a device (including basic information, studies' results, modeling reports, etc.). Used by companies in introducing devices to payers.

Revenue ramp

The degree to which a company expects to grow its revenue over time.

Right of First Refusal

The right that one first party may obtain via a investment or other strategic transaction wherein the second party must offer the terms of any deal with respect to the sale of any shares (preferred or common) or other proposal to the first party before it can offer those same terms to an outside party.

ROI (Return on Investment)

The amount of return made on a given investment.

Royalties

A percentage of commercial sales paid by the licensee/partner to the patent or rights holder.

Royalty anti-stacking provisions

Provisions in a licensing deal that provide a mechanism for the licensee to prevent the licensor from reducing the royalty when other royalties are required for the same product.

RUC (AMA/Specialty Society Relative Valu

The committee within the AMA that assigns relative value units to a new code.

RVU (Relative Value Units)

Units that measure the resources required for a new procedure; used to determine the payment for a new CPT code.

SE (Substantial equivalence)

Demonstration that a new device is nearly the same as a predicate device (in terms of safety and effectiveness) in order to use the 510k pathway

Secondary endpoint

Additional criteria that may be met during a clinical trial, but that are not required to obtain a successful positive clinical trial result. The FDA rarely uses secondary endpoints to gain approval or clearance.

Secondary prevention patients

Patients who have experienced a particular episode of a disease state and are candidates for preventing a recurrence of that episode.

Seed funding

Early-stage funding that supports company creation through prototypes and proof of concept. Typically, this round is often funded by friends, families and/or angels due to low capital requirements.

Seizure

When the FDA takes action against a specific device, taking control over inventory or materials.

SG&A (Selling and General Administrative

Expenses that include salaries, commissions, and travel expenses for executives and salespeople, advertising costs, and payroll expenses.

Sherman Act

A federal act that regulates commercial activity to ensure fair trade and to criminalize monopolies.

Significant risk

A term used by the FDA to indicate that a device is 1) an implant and presents potential for serious risk to the patient; 2) is used to support or sustain life; 3) has a significant use for diagnosing or treating a disease; or 4) otherwise presents serious risk.

Significant risk device

An investigational device that: (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject; (3) is of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) otherwise presents a potential for serious risk to a subject.

SMDA (Safe Medical Devices Act)

A federal regulation that established reporting mechanisms for mortality and morbidity due to medical devices.

SRR (Suggested Restriction Requirement)

The process of grouping claims into fewer than 5 pages and 25 claims so as to have multiple patents from a single original patent that exceeded the 5/25 limit of pages/claims.

Stakeholders

All parties with some interest in the delivery and financing of medical care for patients with a specific medical need.

Standard of care

A treatment process that is well-supported by evidence and that a doctor or medical facility should follow for a particular type of patient, disease or procedure.

Standard treatment

A treatment that is currently in wide use and approved by the FDA and considered to be effective in the treatment of a specific disease or condition.

Stark Law

A law to govern the practice of a physician referring a patient to a medical facility (or form of treatment) in which s/he has a financial interest.

Start-up funding

Funding that is required to make substantial investments in a company. This type of funding often requires millions of dollars and comes from Angels or VCs.

Statistical significance

The probability that an event or difference occurred (or did not occur) by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.

Subject

A human who participates in an investigation, either as an individual on whom, or on whose specimen an investigational device is used or who participates as a control. A subject may be in normal health or may have a medical condition or disease.

Surrogate endpoint

Substitute criteria that are used to prove efficacy in lieu of actual endpoints that may take too long to prove.

Switching costs

The costs of a hospital or medical provider to change from one piece of capital equipment to another or from one treatment process to another; these costs are often a deterrent to trying a new vendor's equipment or new procedures.

SWOT analysis

An analysis, identified by Albert Humphrey (Stanford), of factors affecting a company: strengths, weaknesses, opportunities and threats.

Syndicate

When more than one investor is involved in funding a company.

TEC (Technology Evaluation Committee)

A committee, established by a payer (such as Blue Cross Blue Shield) that evaluates a medical device or procedure to assess whether to pay for the device or procedure and how much.

Term sheet

A document that outlines the terms for a deal and serves as a letter of intent between the investor providing funds and the company receiving them. Terms may include percentage ownership in the company, intellectual property division and other financial and legal concerns.

Third-party payer

Insurance companies (both public and private) who pay on behalf of the patient.

Time to profitability

The amount of time it takes a company to break even, and then turn a consistent operating profit.

Top down model

A sales forecast model that forecasts projected yearly revenue by multiplying the number of customers by the price of the innovation.

Trade secret

Information, processes, techniques, or other knowledge that is not made public but provides the innovator with a competitive advantage.

Trade secret protection

Used in suits when another entity has wrongfully obtained trade information; not protected by government grant as patents are.

Translate

To move an idea, device or other discovery into practice so that it may affect human lives.

Treatment gap analysis

Reviewing methods of treatment for a particular disease in order to uncover areas where treatment is not used or where it is not effective in order to find areas for innovation.

USPTO (United States Patent and Trademar

The government organization that issues patents and trademarks.

Utility patent

A patent; a grant from the government to the inventor for exclusive rights to make use sell or import an invention. A utility patent is the most common type of patent for medical devices and describes an invention in sufficient detail to determine that it is novel, useful and unobvious.

VAI (Voluntary Action Indicated)

A classification from an FDA audit that indicates objectionable conditions or practices were found with a device, but the agency is not prepared to take or recommend any administrative or regulatory action.

Valuation

The worth assigned to the business.

Value Proposition

The sum total of benefits that one party promises to a second party in exchange for payment (or other value-transfer).

Voting Rights

Section of a term sheet that spells out how voting will be orchestrated when shareholder approvals are required.

Warrants

A form of equity that gives the holder the right to purchase a number of shares of a company’s stock at a pre-determined price per share, sometimes subject to other conditions as well.

WHO (World Health Organization)

The direct coordinating authority for health within the United Nations system.

WIPO (World Intellectual Property Organi

The organization responsible for the Patent Cooperation Treaty.

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