This is the most consequential misunderstanding in device patent practice, and it catches sophisticated people.
Holding a patent on your device does not mean you can sell it.
A patent is a right to exclude others. It is not a right to practice your own invention. Those are genuinely different rights, and confusing them has ended companies.
How Both Can Be True
Suppose a competitor holds a patent on a catheter with a braided shaft. You invent a braided-shaft catheter with a novel steerable tip. Your tip is new and non-obvious, so you get a patent on it.
Your patent lets you stop anyone else from making a catheter with your steerable tip.
The competitor's patent lets them stop anyone from making a catheter with a braided shaft, which includes yours.
Both patents are valid. You cannot sell your device without a license, and they cannot use your tip without one. This is called a blocking position, and it is common in incremental fields, which describes most of medical devices.
Patentability asks whether your invention is new. Freedom to operate asks whether making it infringes someone else's claims. Nothing about the first answers the second.
What an FTO Analysis Does
A freedom-to-operate review searches for in-force patents whose claims your product would infringe, in the jurisdictions where you intend to make, use, sell, or import.
The distinctive features compared to a patentability search:
- It looks at claims, not disclosures. What a patent describes is irrelevant to infringement. Only what it claims matters.
- It covers in-force patents only. Expired patents, lapsed patents, and abandoned applications cannot be infringed. A patent that lapsed for unpaid maintenance fees is free to practice.
- It is jurisdiction-specific. Patents are national. A U.S. patent does not stop you selling in Germany.
- It includes pending applications, because published applications signal claims that may issue and may need monitoring.
When to Run One
Before committing to a design. The cheapest time to design around a blocking claim is before tooling, before validation, and before the design history file is built around it. A change that costs weeks at the concept stage costs a year after design freeze.
Before a financing. Investors in device companies ask. Having a considered position is materially better than having none, and a blocking patent discovered during diligence moves terms.
Before launch. Especially in a crowded space with active litigants.
When entering a new market. Different jurisdiction, different patents, different answer.
When a competitor's patent issues in your space and you want to know whether it reaches you.
What the Answer Looks Like
FTO analysis rarely produces "you are clear." It produces a map:
Patents that do not reach you, with reasoning about why your product falls outside the claims.
Patents that arguably reach you, where the analysis turns on claim construction and reasonable people could disagree. This is the largest category and it requires judgment rather than search.
Patents that clearly reach you, which require a decision.
For the last category, the options are: design around, license, challenge validity, buy the patent, wait for expiration if it is close, or accept the risk with a documented basis. All are legitimate business decisions. The one thing you cannot do usefully is not know.
Two Device-Specific Wrinkles
The 510(k) predicate relationship is a signal. Demonstrating substantial equivalence to a predicate device means you are asserting technological similarity to a specific product. That product's patent family is the obvious place to start an FTO review, and your own regulatory file has already identified it.
Design freeze makes it expensive to be late. Once a device is through design controls under 21 CFR 820.30, verification, and validation, changing a component is not just an engineering change. It is a regulatory event with documentation, potential retesting, and possible resubmission. FTO findings that arrive after design freeze cost an order of magnitude more than the same findings six months earlier.
On Willfulness
A recurring question: does knowing about a patent make things worse if you are later sued?
Enhanced damages for willful infringement require egregious conduct, and awareness of a patent is one input. But the answer is not to avoid looking. Deliberately staying ignorant does not help, and the alternative is discovering a blocking patent when a competitor's demand letter arrives, after you have built a business on the infringing design.
The right approach is to look, and where a real risk surfaces, develop a documented basis for your position with counsel. A reasoned analysis is evidence of good faith. It is also privileged, which is a further reason to have this work done through counsel rather than informally.
Scope It to the Decision
A full FTO opinion is a substantial undertaking, and not every situation needs one. What you need depends on the decision it supports.
A landscape review early in development identifies the major players and obvious blocking positions at modest cost, and is often enough to steer design.
A targeted analysis on specific features, or specific competitor families, answers a narrower question well.
A formal written opinion is what you commission before a major commitment or when you need the documented basis for a willfulness defense.
Starting with the lightweight version and escalating where it finds something is usually the right sequence.
The Short Version
Your patent protects you from competitors. It does not protect you from theirs. In a field as incremental as medical devices, blocking positions are normal rather than exceptional, and the cost of finding one scales with how late you find it.
To scope a freedom-to-operate review for your device, request a free consultation.
This article is general educational information, not legal advice, and reading it does not create an attorney-client relationship. Patent law is fact specific and deadlines are unforgiving. For advice on your situation, schedule a consultation.