The medtech roadmap, end to end.

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.

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.

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.

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.

FD&C Act §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 §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.

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.

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.