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[Roadmap](/roadmap)/ [01 · IP Protection](/roadmap/ip-protection)[02 · Regulatory Pathway](/roadmap/regulatory-pathway)[03 · Clinical Evidence](/roadmap/clinical-evidence)[04 · Reimbursement](/roadmap/reimbursement)[05 · Cybersecurity](/roadmap/cybersecurity)[06 · Business Model](/roadmap/business-model)[07 · Go-To-Market](/roadmap/go-to-market)

Step 01 of 7 · Roadmap

# IP Protection

File before you publish, demo, or pitch a stranger

When to start 

Before any external disclosure - ideally pre-incorporation

Duration 

Provisional: 2–4 weeks · Full PCT strategy: 12–18 months

Indicative cost 

USD 3K (provisional) → 30K+ (utility + PCT national phase)

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.

## Why this comes first

Investors will not lead a Series A on an asset that competitors can clone. Strategic acquirers value the IP estate more than the revenue. And every founder eventually gives an unguarded demo at a conference - the question is whether a provisional was on file beforehand.

## What to file

Most medtech roadmaps include a layered IP estate, not a single patent.

-   Provisional patent (USPTO) - locks priority date for 12 months at low cost 
-   Utility patent - the core device, method-of-use, and software claims 
-   Design patent - the industrial design (cheap, often overlooked, hard to design around) 
-   PCT application - extends international filing window to ~30 months 
-   Trademark - device name, company name, key software product names 
-   Trade secrets - manufacturing processes, training data, calibration parameters 

## How it ties to FDA strategy

Method-of-use claims should align to your indication for use statement in the 510(k). If your patent claims a use the FDA hasn't cleared, the claim is unenforceable in commercial settings. Coordinate patent counsel and regulatory counsel from week one.

Artifacts to ship

-   Invention disclosure log (signed and dated) 
-   Provisional patent application (filed) 
-   FTO (freedom-to-operate) opinion before launch 
-   IP assignment agreements from every employee, contractor, and advisor 

Common pitfalls

-   Demo'ing at a conference before filing - kills foreign rights immediately 
-   Forgetting IP assignment from a co-founder who later leaves 
-   Filing claims that don't match the IFU you eventually clear with FDA 
-   Ignoring software/algorithm claims because 'it's just code' 

Primary sources

-   [USPTO - Patent Basics Primary source ](https://www.uspto.gov/patents/basics)
-   [USPTO Patent Public Search Prior-art search ](https://ppubs.uspto.gov/pubwebapp/)
-   [USPTO TEAS (Trademarks) Trademark filing ](https://www.uspto.gov/trademarks)
-   [WIPO PCT System International ](https://www.wipo.int/pct/en/)

Start of roadmap

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Regulatory Pathway

Step 02 · 510(k), De Novo, or PMA - and the Pre-Sub that de-risks each

](/roadmap/regulatory-pathway)

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