--- title: "Start Here - Your US Medical Device Launch Plan" description: "Answer three questions about your device, stage and US status to get an ordered launch checklist covering IP, FDA pathway, evidence, cybersecurity, reimbursement and go-to-market." lang: en json-ld: --- [Skip to content](#main) [ MedTech Launch Guide Education Hub for Founders ](/) [Roadmap](/roadmap) [Topics](/topics) Tools [Pulse](/pulse)Search ⌘K[Start Here](/start) Search ⌘K Start here # Three questions, then your launch plan. The roadmap has seven stages, but you do not start all seven today. Tell us what you are building, how far along you are, and where you sit relative to the US market. You get an ordered checklist with the reason each item matters and a direct link into the lesson. Progress is saved on this device. 01 - What are you building? Software / SaMD or AI Software as a medical device, clinical decision support, AI/ML models Implant or Class III Implantable, life-sustaining, or otherwise high-risk hardware Diagnostic or IVD Lab-developed tests, IVDs, imaging or screening tools Capital equipment Hospital-installed systems, robotics, imaging platforms Wearable or monitoring Body-worn sensors, remote patient monitoring, connected devices 02 - Where are you today? Concept / pre-prototype Idea validated, nothing built yet Working prototype Bench data exists, no FDA contact yet Pre-Sub or design freeze Talking to FDA, locking design and V&V Submission in review 510(k), De Novo or PMA filed with FDA Cleared and commercializing On market, chasing coverage and revenue 03 - What is your US status? US company, US first Domestic entity, FDA is your first regulator Non-US company entering the US CE marked or home-market approved, now targeting FDA Selling in the US already Cleared and shipping, scaling access and reimbursement Answer all three questions above to generate your ordered plan. MedTech Launch Guide The independent education hub for medtech innovators bringing devices to the US market - paired with a live pulse of what FDA, CMS, CISA and investors are doing right now. Sponsored by Blue Goat Cyber Pulse - [Live Pulse](/pulse) - [Funding Tape](/pulse#funding) - [Pitch Decks](/pulse#pitch) - [Cybersecurity](/pulse#cyber) - [Post-mortems](/pulse#failure) Learn - [Founder Roadmap](/roadmap) - [Start here: build my plan](/start) - [Regulatory & Quality](/roadmap/regulatory-pathway) - [Funding & Grants](/pulse#funding) - [Clinical evidence](/roadmap/clinical-evidence) - [Reimbursement](/roadmap/reimbursement) - [Topics & tools](/topics) - [Funding quiz](/quiz) - [Investor Directory](/investors) - [FDA user fees & calculator](/mdufa-fees) - [Cyber budget worksheet](/worksheets/cyber-budget) - [Glossary](/glossary) - [Weekly Brief](/#newsletter) Company - [About](/about) - [Editorial policy](/editorial) - [Tip line · Contact](/contact) - [Privacy](/privacy) - [Terms](/terms) Sister sites [MedTech Terms ↗](https://medtechterms.com) medtechterms.com The full MedTech dictionary. Sourced definitions with a page per term, A-Z and category indexes, learning paths, and side-by-side comparisons. [A-Z index →](https://medtechterms.com/a-z)[Categories →](https://medtechterms.com/categories)[Learning paths →](https://medtechterms.com/paths)[Compare terms →](https://medtechterms.com/compare) [Blue Goat Cyber ↗](https://bluegoatcyber.com) bluegoatcyber.com Medical device cybersecurity practice. Threat modeling, SBOMs, penetration testing, and FDA premarket and postmarket submission support. [FDA premarket cyber →](https://bluegoatcyber.com/services/medical-device-cybersecurity/fda-premarket-cybersecurity/)[Penetration testing →](https://bluegoatcyber.com/services/medical-device-cybersecurity/penetration-testing/)[Threat modeling →](https://bluegoatcyber.com/services/medical-device-cybersecurity/threat-modeling/)[Site index →](https://bluegoatcyber.com/site-index) © 2026 MedTech Launch Guide. Editorial independence is non-negotiable. Sponsored content is clearly labelled.