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Your progress 0 of 16 lessons complete · up next: TAM / SAM / SOM [Start path](/terms/tam-sam-som?from=founder-and-investor-primer) 1. 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. ](/terms/tam-sam-som?from=founder-and-investor-primer)Mark done 2. 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. ](/terms/510k?from=founder-and-investor-primer)Mark done 3. 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. ](/terms/pma?from=founder-and-investor-primer)Mark done 4. 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. ](/terms/de-novo?from=founder-and-investor-primer)Mark done 5. 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. ](/terms/breakthrough-device?from=founder-and-investor-primer)Mark done 6. 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. ](/terms/freedom-to-operate?from=founder-and-investor-primer)Mark done 7. 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. ](/terms/series-funding?from=founder-and-investor-primer)Mark done 8. 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. ](/terms/convertible-note?from=founder-and-investor-primer)Mark done 9. 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. ](/terms/term-sheet?from=founder-and-investor-primer)Mark done 10. 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. ](/terms/valuation-cap?from=founder-and-investor-primer)Mark done 11. 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. ](/terms/cap-table?from=founder-and-investor-primer)Mark done 12. 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. ](/terms/due-diligence?from=founder-and-investor-primer)Mark done 13. 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. ](/terms/strategic-investor?from=founder-and-investor-primer)Mark done 14. 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. ](/terms/m-and-a?from=founder-and-investor-primer)Mark done 15. 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. ](/terms/exit-multiple?from=founder-and-investor-primer)Mark done 16. 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. ](/terms/ipo?from=founder-and-investor-primer)Mark done Finished the path? Test yourself with a quiz tailored to these 16 terms. [Take the Founder & Investor Primer quiz](/quiz?path=founder-and-investor-primer) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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