GLOSSARY

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Term Definition
Coding

The process of assigning a specific, identifiable code to a medical procedure or process.

COGS (cost of goods sold)

Raw materials costs for a product.

Common stock

Equity in a company that confers on shareholders voting and pre-emptive rights (the right to keep a proportionate ownership of the company by buying additional shares when new stock is issued).

Comparables analysis

Evaluating the pricing strategies (and associated reimbursement status) of similar offerings in the field.

Competitive benchmarks

Benchmarks and comparable data related to the type of business model the company has chosen and the sector/industry within which the company operates.

Conditions precedent

Section of a term sheet that outlines what steps must be taken before the financing deal proposed in the term sheet can be finalized.

Controlled trial

A trial that uses two groups: one that receives treatment, and a second, control group, that does not, in order to compare outcomes.

Conversion, Automatic conversion

Section of a term sheet that that describes how preferred shares will convert to common shares.

Convertible bonds

A hybrid debt-equity alternative to companies seeking financing. A type of bond that can be converted into shares of stock of the issuing company, usually at some pre-announced ratio.

Core laboratory

Laboratories that analyze data from a clinical trial; these laboratories often have specialized equipment and expertise.

Corporate investment

When Corporations invest in new companies by (1) the purchase of equity in support of a research and development or a licensing agreement, or (2) traditional venture investments.

Correction

Repair or modification of a distributed product while it is still under the control of the manufacturer.

Cost-effectiveness model

A model for determining product value where cost is expressed per unit of meaningful efficacy, usually used comparatively across interventions.

Cost-utility analysis

A model for determining product value where cost is assigned for quality of life and years lived. It is based on clinical outcomes measures related to quality of life and/or disability and mortality.

Cost/benefit analysis

A model for determining product value that demonstrates that the money spent on the device is lower than the total cost of the outcomes of the disease or of current standard therapy.

CPT (Common Procedural Terminology) code

Codes used to classify medical procedures in a standard way so that the same procedure is reimbursed in the same way across all facilities. Also known as HCPCS Level 1 codes.

CRO (Contract Research Organization)

Contract (or Clinical) Research Organization; an independent organization that provides management services for clinical trials.

Cycle of care

A description of how a patient interacts with the medical system.

Debt funding

Funding that is repaid with interest. A loan.

Design controls

One subsystem of a Quality Management system; Controls that ensure that every device performs as manufactured.

Design creep

Ongoing, minor changes in developing a device that can lead to significant delays and issues with intellectual property and regulatory clearance.

Design validation

Ensuring that a design does what it has intended to do.

Design verification

Ensuring that a design meets product specifications.

Determination meeting

A formal meeting with the FDA to request approval of the design for a clinical study.

Diagnostic trials

Trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studied.

Differential pricing

Pricing the same product or service differently for different customer segments, e.g. discounts for large buyers.

Dilution

Section of a term sheet that stipulates how conversion prices will be calculated if future rounds of financing are dilutive to preferred shareholders' holdings (i.e. they reduce the total value of the shareholder’s ownership stake in a company).

Direct sales model

Hiring a sales force within a company to sell to customers directly.

Discounted cash flow analysis

An analysis that uses cash flows discounted back to present at a discount rate that reflects the returns the shareholders expect from the stock of the company.

Distribution play

To focus on product breadth and channel relationships rather than on product superiority.

Dividend provisions

Section of a term sheet that describes the conditions for which dividends will be paid. A divided is a payment to the shareholder that is proportional to the shareholder’s ownership of a company.

Divisional

A type of patent application that claims a distinct or independent invention based upon pertinent parts carved out of the specification in the original patent.

DRG (Diagnosis Related Group)

A set of codes that are grouped together by diagnosis; used specifically for coding hospital related billing for patient encounters. Replaced recently by MS-DRG (Medicare Severity DRGs that include adjustments based on co-morbidities and complications).

DSMB (Data Safety and Monitoring Board)

Data Safety and Monitoring Board; An independent body that reviews results of clinical trials.

DSP (Digital Signal Processor)

Digital Signal Processor; one potential component of the electrical circuitry of a device.

DTC (Direct-to-Consumer)

A type of marketing that targets the end user of a product, as opposed to the physician or other medical professional.

DTP (Direct-to-Patient)

A type of marketing that targets patients directly, as opposed to physicians or other health care professionals.

Due diligence

An iterative process of discovery, digging into detail about the various elements of a business plan of a start-up company or licensing opportunities.

Earn out acquisition

An acquisition in which additional payments are made to the seller after the sale day if the acquired company reaches pre-specified milestones.

Efficacy endpoints

A result during an animal or clinical study that demonstrates efficacy (i.e. a therapeutic effect). Endpoints are what a study is designed to prove.

Eligibility criteria

Summary criteria for participant selection in clinical studies; includes Inclusion and Exclusion criteria.

Empirical

Based on experimental data, not on a theory.

Epidemiology

Study of factors affecting the health and illness of a population that are used as the basis of making interventions in the interest of public health.

EPO (European Patent Office)

The office that provides unified patent filing for 38 European countries.

Equipment & facility controls

One subsystem of a Quality Management system; it ensures that standard operating procedures have been designed and implemented for all equipment and facilities.

Equity ownership

Ownership of a piece of a company.

ESD (Examination Support Document)

A document that allows the inventor filing a patent to go beyond the 5/25 limit of pages/claims.

Ethnographic research

Understanding a particular culture or way of life by studying the members of that culture or group.

Evergreening

The process of introducing modifications to existing inventions and then applying for new patents to protect the original patent beyond its original 20-year patent.

Evidence-based

Treatments, guidelines, and processes based on the results and outcomes generated from experiments and observation that uses specific evidence of outcomes and suggests treatment or processes based on such evidence.

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