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)