GLOSSARY

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D

Term Definition
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.

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