All pathsFounders · Investors · BD · 16 terms

Founder & Investor Primer

Name: Founder & Investor Primer
Availability: InStock

The regulatory, market, and financing vocabulary a MedTech founder or investor needs to evaluate a device opportunity.

Your progress

0 of 16 lessons complete · up next: TAM / SAM / SOM

Start path

1

Commercialization

TAM / SAM / SOM

Market sizing framework: total, serviceable available, and serviceable obtainable.

Why this term here: How to describe market size without eye-rolls from experienced investors.
2

Regulatory

510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

Why this term here: The pathway most 'faster to market' pitches are secretly relying on.
3

Regulatory

Premarket Approval(PMA)

FDA's most stringent device marketing application, required for high-risk Class III devices.

Why this term here: The pathway that changes fundraise size, timeline, and risk profile.
4

Regulatory

De Novo Classification Request(De Novo)

Pathway to classify novel low- to moderate-risk devices that lack a predicate.

Why this term here: The pathway for novel devices; often longer than founders assume.
5

Regulatory

Breakthrough Device Designation(BDD)

FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.

Why this term here: The designation founders overuse in pitch decks; know what it actually grants.
6

Commercialization

Freedom to Operate(FTO)

Analysis of whether a product can be sold without infringing third-party IP.

Why this term here: Patent clearance work that should happen before, not after, term sheet.
7

Investment & Finance

Series A / B / C Financing Rounds

Sequential priced equity rounds in venture-backed companies, typically progressing from product-market validation (A) to scale (B) to growth (C+).

Why this term here: Series A / B / C mechanics for MedTech-specific dilution and timing.
8

Investment & Finance

Convertible Note

Short-term debt that converts into equity at a future financing round.

Why this term here: The pre-priced round instrument every founder eventually sees.
9

Investment & Finance

Term Sheet

Non-binding outline of the key economic and control terms of an investment.

Why this term here: The non-binding document that quietly binds you to almost everything.
10

Investment & Finance

Valuation Cap

Maximum company valuation at which a SAFE or note converts to equity.

Why this term here: The most-negotiated clause in a SAFE or note.
11

Investment & Finance

Capitalization Table(Cap Table)

Ledger of all securities issued by a company and who owns them.

Why this term here: The ownership ledger that determines every future dilution conversation.
12

Investment & Finance

Due Diligence

Investigation of a company before an investment, financing, or acquisition.

Why this term here: What investors actually ask for; front-load the answers.
13

Investment & Finance

Strategic Investor

Corporate investor with operational, not just financial, motives.

Why this term here: Corporate venture arms: cheap capital with real product-strategy strings.
14

Investment & Finance

Mergers and Acquisitions(M&A)

Transactions in which one company acquires or combines with another, the dominant MedTech exit path, typically a strategic acquisition by an established player.

Why this term here: The most common MedTech exit; understand it before you build for IPO.
15

Investment & Finance

Exit Multiple

Valuation ratio applied at exit, e.g., enterprise value to revenue.

Why this term here: How MedTech multiples differ from software and what drives them.
16

Investment & Finance

Initial Public Offering(IPO)

First sale of a company's stock to public investors via a registered SEC offering, typically on NYSE or Nasdaq.

Why this term here: The rarer MedTech exit; know the readiness bar.

Finished the path? Test yourself with a quiz tailored to these 16 terms.

Take the Founder & Investor Primer quiz

Founder & Investor Primer

TAM / SAM / SOM

510(k) Premarket Notification(510(k))

Premarket Approval(PMA)

De Novo Classification Request(De Novo)

Breakthrough Device Designation(BDD)

Freedom to Operate(FTO)

Series A / B / C Financing Rounds

Convertible Note

Term Sheet

Valuation Cap

Capitalization Table(Cap Table)

Due Diligence

Strategic Investor

Mergers and Acquisitions(M&A)

Exit Multiple

Initial Public Offering(IPO)