GLOSSARY

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S

Term Definition
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.

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.

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