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Term Definition

A method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms.

Randomized trial

A trial that uses random assignment of patients to the treatment and control groups.


A method of removing all or a particular product from the market in an effort to minimize the risk to patients.

Records, Documents & Change Controls

One subsystem of a Quality Management system; Controls that manage documentation and records for all aspects of the quality systems in place.


Section of a term sheet used to allow investors to redeem all or a portion of their investment if liquidity has not been achieved within a finite number of years.

Reduction to practice

Taking an invention beyond the concept stage; showing that the invention actually works. As opposed to what an invention was conceived.

Reference pricing

Using the prices of comparable products used in health care systems outside one country to make decisions on payment within the country without necessarily considering any compensation for economic and regulatory differences.

Registration rights

Section of a term sheet that outlines the rights of preferred investors to force the company to register its stock for public offering under SEC rules.


A collection of cases that have been performed in real world settings outside the scope of a formal comparative protocol; also called observational studies.


The act of paying for a medical device, procedure, visit or other element of patient care by a third-party payer.

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.


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.

RVU (Relative Value Units)

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

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