GLOSSARY

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Term Definition
Pass-through code; c-code

A code that is issued to cover the cost of a device that is incremental to the services provided under an existing APC code, or set of codes. The cost of the device may be bundled into this transitional APC code, or may still be billed separately under a temporary pass-through code.

Pathophysiology

Study of the change of the normal mechanical, physical, and biochemical functions of a human due to disease or other interruption to normal function.

Patient " Towers"

Segments of patient populations based on epidemiological factors, market size and other important factors to determine the most favorable target for a device.

Pay-for-Performance

Setting prices contingent on the realization of specific results from a product or device. A new, if somewhat controversial, approach to healthcare fee structuring.

Payer advisory board

A board consisting of key opinion leaders and medical directors from select payers in a target payer segment. They advise start-up companies in issues of reimbursement.

PCT (Patent Cooperation Treaty)

A treaty that establishes unified patent filing for foreign countries. Issued by the World Intellectual Property Organization (WIPO).

PDP (Product Development Protocol)

A contract that describes agreed-upon details of design and development activities, the outputs of these activities and the acceptance criteria for these outputs.

Peer review

Review of a clinical trial or study by experts. These experts review the trials for scientific merit, participant safety, and ethical considerations. Peer-reviewed literature refers to scientific articles published in credible academic journals where a panel of physicians has reviewed the trial report.

PHI (Protected Health Information)

A patient’s personal health information; protected by HIPAA.

PI (Principal Investigator)

The person responsible for conducting a clinical trial. May also be someone who manages a grant or contract for a particular research project.

PIC (Programmable Intelligent Computer)

One potential component of the electrical circuitry of a device.

Piggybacking

Using a single animal for multiple technology studies.

Pilot trial

Early clinical trial, usually conducted as a registry.

Pivotal trial

Typically larger, controlled studies designed to test specific hypotheses when significant clinical data are necessary. Are often used to support the submission of a PMA application for a new device.

PMA (Pre-market Approval)

The most stringent pathway through the US regulatory process for a device. A PMA is necessary when a new device is not substantially equivalent to any existing devices that were approved before 1976.

POC (Point of care)

Point of care is the place in which the actual surgery, medical intervention, or other medical procedure is done.

Porter's five forces

Five forces, identified by Michael Porter (Harvard), that influence competition within an industry: rivalry, new entrants, substitute products, suppliers' bargaining power and buyers' bargaining power.

Post-marketing trial

Trials performed following the commercial approval of a device in order to gain acceptance of the device in the field.

Post-money valuation

A company’s value after it obtains outside funds.

Power

Statistical power refers to the probability of detecting a meaningful difference, or effect, if one were to occur. Ideally, studies should have power levels of 0.80 or higher - an 80 percent or greater chance of finding an effect, if one exists.

Power calculation

A calculation used in clinical trials to determine the optimum number of patients to include in order to demonstrate efficacy.

Pre-money valuation

A company’s value before it receives a subsequent outside round of financing.

Preferred stock

Equity in a company that gives shareholders a liquidation preference, meaning that preferred stock holders are paid before common stock holders if a company is sold or its assets are liquidated. Holders of preferred stock are also given priority regarding the payment of dividends. Investors, such as venture capitalists, often are granted preferred stock in return for funding.

Primary endpoints

Criteria that the company, investigators and FDA agree are required to be met to prove device efficacy during a clinical trial. For the device to receive approval, these endpoints must be met. The number of patients needed in a clinical trial is based on finding a statistically meaningful difference in these endpoints.

Primary prevention patients

Patients who are risk to experience a particular episode of a disease state.

Prior art

Any previous subject matter that is relevant to and published or known generally in the field prior to an invention.

Priority date

The first filing date of a patent application. This date is used to help determine the novelty of an invention compared to prior art.

Protective provisions

Section of a term sheet that outlines the percentage of preferred shareholders whose approvals are needed for a company to take certain actions.

Provisional patent

A patent filing that is less costly and rigorous to file but that only ensures a filing date prior to filing for a regular patent. Provisionals expire in 12 months if the provisional patent is not converted to a regular patent during that time.

Proxy companies

Companies whose operations resemble what is required to commercialize an innovation. Also known as comparable companies. Used to validate financial models.

Proxy material

Material that may be used in prototyping due to its similar characteristics to the material that needs to be tested

Public Disclosure

The moment an inventor describes an invention in a public setting; discussions with a single individual may be considered public settings

Public Investment

When the public buys stock in a company.

PubMed

Published Medicine, a government-funded search engine that provides access to biomedical research papers that have been published in professional journals.

QA (Quality Assurance)

The process that ensures that the product will operate according to its specifications.

QC (Quality Control)

The activities designed to catch defective products in the manufacturing before they are released to the customer.

QMS (Quality Management System)

A system through which Quality Assurance and Quality Control are implemented.

QSIT (Quality Systems Inspection Techniq

A guide describing the way in which FDA investigators conduct an inspection of quality systems.

QSR (Quality System Regulation)

Regulations regarding the manufacturing, design, material handling and product testing of devices.

Quality of life

The degree of well-being felt by an individual.

Randomization

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.

Recall

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.

Redemption

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.

Registry

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

Reimbursement

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

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