--- title: "MedTech Founder Roadmap - 7 Stages, End to End" description: "Seven workstreams every US-bound medtech company runs in parallel - IP, regulatory, clinical, reimbursement, cyber, business model and GTM." lang: en json-ld: | { "@context": "https://schema.org", "@type": "CollectionPage", "name": "MedTech Founder Roadmap", "description": "Seven workstreams every US-bound medtech company runs in parallel.", "url": "https://medtechlaunchguide.com/roadmap", "hasPart": { "@type": "ItemList", "numberOfItems": 7, "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "IP Protection", "url": "https://medtechlaunchguide.com/roadmap/ip-protection" }, { "@type": "ListItem", "position": 2, "name": "Regulatory Pathway", "url": "https://medtechlaunchguide.com/roadmap/regulatory-pathway" }, { "@type": "ListItem", "position": 3, "name": "Clinical Evidence", "url": "https://medtechlaunchguide.com/roadmap/clinical-evidence" }, { "@type": "ListItem", "position": 4, "name": "Reimbursement", "url": "https://medtechlaunchguide.com/roadmap/reimbursement" }, { "@type": "ListItem", "position": 5, "name": "Cybersecurity", "url": "https://medtechlaunchguide.com/roadmap/cybersecurity" }, { "@type": "ListItem", "position": 6, "name": "Business Model", "url": "https://medtechlaunchguide.com/roadmap/business-model" }, { "@type": "ListItem", "position": 7, "name": "Go-To-Market", "url": "https://medtechlaunchguide.com/roadmap/go-to-market" } ] } } --- [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 Founder Roadmap · 7 stages # The medtech _roadmap_, end to end. Seven workstreams every US-bound medical device company will run in parallel - from first invention disclosure to fully contracted GTM. Each stage links to a working brief: what to build, what to ship, what to budget, and what kills founders here. 1. [ 01 ## IP Protection File before you publish, demo, or pitch a stranger In the US, you have a 12-month grace period after public disclosure to file - most other markets do not. Treat any pitch deck, conference poster, or non-NDA conversation as a disclosure event. File a provisional first, then build the full prosecution strategy around your FDA pathway. Duration Provisional: 2–4 weeks Indicative cost USD 3K (provisional) → 30K+ (utility + PCT national phase) ](/roadmap/ip-protection) 2. [ 02 ## Regulatory Pathway 510(k), De Novo, or PMA - and the Pre-Sub that de-risks each Pathway selection determines your timeline, capital needs, and exit comparables. Search the FDA classification database for your three-letter product code first; if a predicate exists, you're likely 510(k). If none exists, you're De Novo. If your device is high-risk Class III, you're PMA - plan for clinical trials and a multi-year timeline. Duration 510(k): 6–12 months FDA review Indicative cost USD 50K–200K (510(k)) ](/roadmap/regulatory-pathway) 3. [ 03 ## Clinical Evidence IDE, IRB, ClinicalTrials.gov - generate the data FDA and CMS both want Most 510(k)s do not require a clinical study; most De Novos and all PMAs do. Even if FDA doesn't require evidence, CMS will - design the trial endpoints to satisfy both regulators and payers in a single study. Foreign data can support a 510(k) but rarely a PMA without US enrollment. Duration Feasibility: 6–12 months Indicative cost USD 250K (small feasibility) → 5M+ (pivotal IDE) ](/roadmap/clinical-evidence) 4. [ 04 ## Reimbursement Coding, coverage, payment - the three legs every payer requires FDA clearance grants the right to sell. CMS coverage determines whether anyone will buy. Reimbursement strategy needs to start at the same time as the clinical trial - not after clearance - because CPT applications take 18–36 months and coverage determinations require evidence already in the literature. Duration CPT Cat I: 24–36 months Indicative cost USD 100K–500K (consulting + dossier) before payer engagement ](/roadmap/reimbursement) 5. [ 05 ## Cybersecurity FD&C Act Section 524B - premarket package + lifelong postmarket plan Any device that includes software, connects to the internet, and has features vulnerable to cyber threats is a 'cyber device' under FD&C Act Section 524B. FDA will refuse to accept a 510(k), De Novo, or PMA that does not include the required cybersecurity content - regardless of clinical merit. Duration Ongoing - premarket package builds over 6–12 months; postmarket monitoring is continuous Indicative cost USD 50K–250K premarket ](/roadmap/cybersecurity) 6. [ 06 ## Business Model Capital equipment, consumables, SaaS, or service - pick on purpose Business model selection determines your unit economics, the kind of investor who'll fund you, and the comparable companies your exit will be priced against. Most medtech founders default to a model without examining alternatives - and discover at Series B that the wrong choice has compounded. Duration Initial model: 1–2 months Indicative cost Internal - but the wrong choice can cost 50%+ of enterprise value at exit ](/roadmap/business-model) 7. [ 07 ## Go-To-Market KOLs, IDN selling, GPO contracting, and the chasm in between Hospital sales cycles run 12–24 months and route through clinical champions, value-analysis committees, supply chain, and finance. The fastest medtech launches engineer all four conversations in parallel from day one - not sequentially after FDA clearance. Duration Early adopter sites: 6–12 months Indicative cost USD 1.5M–4M/year per direct sales territory at launch ](/roadmap/go-to-market) 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. 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