The pulse of MedTech capital, regulation & survival.

Funding rounds decoded, pitch deck teardowns, cybersecurity budgets that pass FDA scrutiny, and the un-glamorous post-mortems behind 90% of MedTech failures. Built for founders and the investors who back them.

Live data sources

openFDA · CISA · ClinicalTrials.gov

FDA cyber guidance

Feb 3, 2026 final

Refreshed

Daily, automated

Unlike SaaS, MedTech rounds aren't sized to revenue - they're sized to the next de-risking event (predicate confirmed, FIH read-out, FDA clearance, first paying hospital). Investors price the round based on what milestone the cash unlocks. Use this as a yardstick before benchmarking the live tape below.

Capital and clearance vocabulary collide in medtech. These are the terms that decide whether a term sheet, a 510(k) plan or a board update lands the way you intended.

Dilution

Ownership %

The reduction in existing shareholders' ownership percentage when new shares are issued. A $5M seed at a $20M post-money values founders' stock at 75% - that 25% is the dilution. Compounds across rounds; a typical medtech founder team holds 10–25% by Series B.

De-risking milestone

Why this round exists

A specific, verifiable event that materially lowers technical, regulatory or commercial risk - and unlocks the next round at a higher valuation. Examples: predicate confirmed via Pre-Sub, FIH read-out, FDA clearance, first paid hospital deployment. Investors price rounds on what milestone the cash buys.

Predicate

FDA · 510(k)

A legally marketed medical device that your 510(k) submission claims substantial equivalence to. Choosing a predicate determines your indication for use, performance testing burden and review timeline. The 'most cleared' predicate is rarely the most defensible one.

eSTAR

FDA submission format

Electronic Submission Template And Resource - FDA's mandatory interactive PDF template for 510(k) submissions (and most De Novos). Built-in completeness checks reduce Refuse-to-Accept bounces. Not a software platform; a structured form you fill out and upload via the CDRH Customer Collaboration Portal.

Pre-money / Post-money

Valuation

Pre-money is the company's value before new capital comes in; post-money is pre-money plus the new round. A $5M raise at $15M pre = $20M post, and the new investor owns 25% ($5M / $20M). Always confirm which one a term sheet quotes - the difference is real ownership.

Pro-rata rights

Follow-on protection

Contractual right for an existing investor to participate in future rounds at the same proportional ownership. Most seed funds insist on it; aggressive Series A leads sometimes try to strip it. Matters because medtech requires multiple capital injections before clearance.

Liquidation preference

Exit waterfall

The multiple of invested capital a preferred shareholder gets paid before common stock at exit. 1× non-participating is founder-friendly; 2× participating means investors take 2× their money plus their pro-rata share of the rest. Stacks across rounds - model the waterfall before signing.

Burn multiple

Capital efficiency

Net cash burned ÷ net new ARR over the same period. Pre-revenue medtechs use a modified version: cash burned per de-risking milestone hit. Investors at Series B+ benchmark burn multiple to decide whether the next round is an extension or a step-up.

Bridge round

Between priced rounds

Convertible note or SAFE raised between priced rounds - typically to extend runway to a missed milestone (FDA delay, slower-than-modelled enrollment). Often signals a down-round risk; sophisticated founders structure bridges with caps that protect against punitive conversion.

Strategic vs financial investor

Cap table mix

Financial investors (VC, growth equity) optimise for IRR and exit. Strategics (J&J, Medtronic, Stryker venture arms) optimise for product line gaps and pre-emption. Strategics on the cap table early can deter competing acquirers later - useful sometimes, value-destroying others.

FDA clearances, recalls, CISA medical-device advisories, and new clinical trial starts, pulled straight from government APIs and refreshed every morning at 06:10 UTC, alongside a live public-market strip for the large-cap MedTech names.

1. 01

   The Clinical Problem

   Frame the unmet need with a real patient and a real number - incidence, mortality, cost burden.

   Series A

   Pair the patient story with bottom-up incidence × cost burden you've validated with KOLs.

   30s
2. 02

   Solution & Mechanism

   Photo of the device. One sentence on how it works. Resist the urge to teach physiology.

   Series A

   Show the production-intent device + a diagram of the connectivity / data flow.

   Cyber angleOverlay a trust boundary on the data-flow diagram. Investors love seeing where PHI lives.
   45s
3. 03

   Evidence to Date

   Bench data, animal data, first-in-human. Investors discount unsubstantiated claims by 80%.

   Series A

   First-in-human results + IRB-approved feasibility study readout.

   60s
4. 04

   Regulatory Path

   510(k), De Novo, or PMA - with predicate device, expected timeline, and pre-sub history.

   Series A

   Pre-Sub feedback in hand. eSTAR-ready package in build.

   Cyber angleState that your eSTAR cyber sections (SBOM, threat model, SPDF) are drafted.
   45s
5. 05

   Reimbursement Strategy

   CPT code path, payor conversations, and your number for cost-per-procedure savings.

   Series A

   Payor advisory board + economic model with 3 payor archetypes.

   60s
6. 06

   Market Sizing - Bottom Up

   Procedures × ASP × penetration. Top-down TAMs get instantly dismissed.

   Series A

   Add geographic + indication-expansion layers with timing.

   45s
7. 07

   Competitive Landscape

   2x2 with axes investors actually care about. Show the moat - IP, data, switching cost.

   Series A

   IP claims granted/pending. Data moat starting to compound.

   Cyber angleAdd a security-posture row: most incumbents still ship without an SBOM.
   30s
8. 08

   Go-To-Market

   KOLs, IDN strategy, and the first 10 hospitals. Specificity wins.

   Series A

   First 10 target hospitals + which IDNs they belong to.

   Cyber angleMention the hospital MDS2 / HIPAA security questionnaire is pre-filled and ready.
   45s
9. 09

   Team

   Ex-operators from the field you're disrupting. Highlight prior FDA clearances.

   Series A

   Full exec bench except CCO. Prior FDA clearances on the team.

   Cyber angleFractional CISO or named security lead. Cyber owner appears on the org chart.
   30s
10. 10

    Financials & The Ask

    18-24 months of runway, milestones tied to value inflections, post-money expectation.

    Series A

    $8–20M to clearance + early commercial. Milestones tied to submission.

    Cyber angleBreak out the $200–500K cyber line tied to submission milestone.
    60s

510(k), De Novo, PMA, HDE, Breakthrough, Pre-Sub - each pathway has a different timeline, a different bar, and a different cybersecurity package. Synthesised from Blue Goat Cyber's regulatory playbook.

Six routes to market

Class I, II, III - what changes for cyber

Cybersecurity artifact crosswalk

The 5-step plan

The single biggest mistake: treating cybersecurity as a final-mile add-on. Every pathway above rewards teams that build evidence in parallel with engineering.

A stage-by-stage guide for connected Class II MedTech founders - drawn from Blue Goat Cyber's 250+ FDA submissions (100% success rate). Class III adds 30–50%; pure SaMD shaves ~20%.

Allocate 2–5% of every round to cybersecurity through Series A - then transition to 1–2% of opex as a continuous postmarket program from Series B onward.

Underspending here is the single most common reason FDA submissions stall - and the most expensive line item to backfill late.

Round by round

Five budget rules

Why most MedTech startups never reach durable revenue.

A working taxonomy of failure modes drawn from public MedTech wind-downs, FDA refuse-to-accept patterns and CB Insights / Silicon Valley Bank post-mortems. Read it before your next board meeting.

A curated index of the accelerators, regulators, communities, books and vendors that meaningfully move a MedTech startup forward. Featured listings are sponsors or programs we've personally vetted with founders.