How To File a Medical Device Patent: A Comprehensive Guide
Learning how to file a medical device patent is crucial for innovators in the MedTech industry, as navigating this complex path can be daunting. This article paves the…
[INDUSTRY]Medical devices and MedTech
Medical device patent attorneys for MedTech founders
We protect the device, the software inside it and its name, timed around your FDA path, with one flat fee for each step.
Your attorneys
Andrew RapackeManaging Partner · Registered Patent AttorneyFormer Naval Engineering Officer. M.S. in electrical and electronics engineering.
Chris WattRegistered Patent Attorney · Former USPTO ExaminerSoftware, AI and machine learning, and MedTech. A full-stack software engineer.
[01]Who it's for
For the people who build medical devices.
From a surgeon's first prototype to a company adding to its portfolio, the work starts the same way. Find out what is new, then protect it before anyone else sees it.
Device startups
Founders turning a clinical idea into a product, protected before the first investor meeting or trial.
Surgeons and clinicians
Inventors who built a better instrument or tool in practice and want to own it before it spreads.
SaMD and AI teams
Software that informs a diagnosis or treatment, protected as a method and timed with its FDA pathway.
Growing MedTech companies
New filings and continuations on predictable flat fees, so the portfolio keeps pace with the product line.
[02]What's protectable
Four things worth protecting in a device.
Most devices carry more than one kind of protection. A patent on how it works, a design patent on how it looks and a trademark on its name each stop a different kind of copy.
01Utility patent
The device and how it works
The mechanism, the structure and the way it is used. Claims are written around what makes your device work better than what clinicians use today.
- Instruments and implants
- Delivery mechanisms
- Wearables and sensors
- Methods of manufacture
Flat fee, quoted before work begins02Utility patent
Software as a medical device
Algorithms that analyze images, signals or patient data, claimed as a technical process tied to a clinical result rather than an abstract idea.
- Diagnostic and imaging software
- AI and machine learning models
- Monitoring and alerts
Flat fee, quoted before work begins03Design patent
The look of the housing
The ornamental design of the housing, the handle or an on-screen interface, protected for 15 years from grant.
- Housings and handles
- Wearable form factors
- Device interfaces
USPTO denies it, full refund*04Trademark
The device name
Clear and file the product name before your regulatory filings and labeling carry it, so the name you launch with is one you can keep.
- Device and product names
- Logos
- Platform names
Approved, or your money back*
Some things stay secret
A manufacturing process no one can see from the finished device may be worth more as a trade secret than as a published patent. Your attorney tells you which on your first call.
[03]The flat-fee path
Search, provisional, utility. Flat fees at every step.
Every step is quoted before any work begins, and the search fee is credited toward a design or non-provisional application. Most device founders file a provisional before any public disclosure, then the full application within 12 months.
01Start here
Patentability search
$999
Patentable or your money back. Credited toward a design or non-provisional application
- An invention discovery call with your attorney
- A search of US and foreign patents and published applications
- A written patentability report and a review call
Report in about 5 days
Not patentable, full refund*02Then
Provisional patent
$2.5k–3.5k
- A strategy call to capture how the device works
- Drafted by a registered patent attorney
- You review and approve it before filing
Patent pending the day it is filed
Patentability issues, full refund*03Within 12 months
Non-provisional patent
$7k–12k
Drawings and USPTO filing fees included
- Claims and a full specification written for examination
- Formal drawings and USPTO filing fees
- Complex devices quoted flat on your call
Filed before your 12-month deadline
Flat fee, not covered by the guarantee
Alongside the patent
- Design patentFor the housing or interface, office actions included$3,200USPTO denies it, full refund*
- TrademarkFor the device name, USPTO fee for one class included$2,000Approved, or your money back*
*Refunds subject to the RLG Guarantee Policy in your engagement letter. Utility (non-provisional) patents are quoted flat and are not covered by the guarantee. How The RLG Guarantee works
[04]FDA and regulatory
Two paths to market. Plan them together.
A patent and an FDA clearance answer different questions. The patent decides who can make and sell the device. The FDA decides whether it can be marketed at all. The timing of one shapes the other.
PatentWho can make and sell it
- $99901$999SearchPatentable, or your money back
- File first02File firstProvisionalPatent pending, before any disclosure
- Month 1203Month 12Full applicationWithin 12 months
- USPTO04USPTOExaminationThe USPTO reviews the claims
- 05GrantedRights you can enforce
FDAWhether it can be marketed
- Disclosure risk01Disclosure riskDesign and testingBench and clinical work
- FDA filing02FDA filingSubmission510(k), De Novo or PMA
- FDA03FDAReviewThe FDA asks questions
- 04Cleared or approvedAllowed on the market
- 05LaunchLabeling and marketing claims
File before you disclose
Trial protocols, conference abstracts, investor decks and published clearance summaries can all make an invention public. File at least a provisional first.
Clearance is not protection
FDA clearance lets you market a device. It does not stop a competitor from copying it. Only a patent, design patent or trademark does that.
Keep the story consistent
What you tell the FDA about how the device works and what it does should not contradict what your patent application says.
Statements of efficacy in device patentsUse the regulatory clock
Patent term runs from filing while premarket review takes time. Devices that go through premarket approval may qualify for a patent term extension.
How patent term extension works
General information, not legal or regulatory advice. Your FDA pathway depends on the device and its classification.
[05]Related services
Services for medical device companies.
One firm for the patent, the brand and the agreements around them.
- Medical device patentsDevices, diagnostics and MedTech software
- Provisional patents, covered by The RLG GuaranteePatent pending while you build and test
- Design patents, covered by The RLG GuaranteeProtect how the device looks
- Utility patentsProtect how it works
- Trademarks, covered by The RLG GuaranteeRegister the device and company name
- FDA regulatory complianceCounsel on the regulatory side of launch
- IP licensing agreementsLicense a device or technology in or out
- Patent litigationEnforce or defend a device patent
[06]Questions
Before you file.
Still deciding? Your first call is free and comes with a straight answer on whether to file.
Book A Free Strategy CallWhen should I file a patent on my medical device?
Before any public disclosure. That includes trial protocols, conference talks, investor decks shared without an NDA and sales. The US gives inventors a one-year grace period after their own disclosure, but most other countries do not, so filing a provisional first keeps your international options open.
Can software as a medical device be patented?
Often, yes, when it is claimed as a specific technical process tied to a clinical result, such as how an algorithm processes an image or a sensor signal. Software that only collects or displays data is less likely to qualify. The patentability search tells you where your invention stands before you file.
Does FDA clearance protect my device from copies?
No. Clearance or approval lets you market the device. It does not stop anyone from making something similar. Protection comes from patents on how it works and how it looks, and a trademark on its name.
How much does a medical device patent cost with your firm?
Flat fees at every step. A $999 patentability search, a provisional application at $2,500 to $3,500 depending on the invention, and a non-provisional application at $7,000 to $12,000 with drawings and USPTO filing fees included. Every fee is quoted before work begins, and the search fee is credited toward a design or non-provisional application.
What does The RLG Guarantee cover for medical devices?
The patentability search, the provisional application, design patents and trademarks. If the search finds your invention is not novel, you get a full refund or another search. If patentability issues come up on your provisional, a full refund or more searches. If the USPTO denies your design application, you get a full refund. If it refuses your trademark, you get a refund or a new mark. Non-provisional applications are not covered. Refunds are subject to the RLG Guarantee Policy in your engagement letter.
[07]Learning Center
Go deeper on medical device patents.
Types of Claims In Medical Device Patent Applications
In the US, assuming the statutory criteria are met, patents are granted by the US Patent & Trademark Office (USPTO) to an inventor for his or her new invention. The…
Types of Medical Device Patents
Medical devices can be protected by utility, provisional and design patents. Here is how each type works, how long it lasts, and why design patents add value to a medical device IP portfolio.
IP and FDA Regulatory Strategies Often Go Hand-In-Hand
In the medical device industry, it is common for medical device companies to seek regulatory approval on new medical devices and innovations from the Food and Drug…
Common Patent Eligibility Rejections for Medical Device Inventions
Inventors are generally familiar with the requirements of novelty and non-obviousness with respect to the patentability of an invention over related disclosures in the…
Do Not Underestimate the Value of Design Patents In A Medical Device IP Portfolio
The US Patent Act allows inventors to patent many types of inventions. In general, 35 U.S.C. §101 covers what are generally called “utility” patents and §171 governs what…
[08]Client reviews
Founders who filed with us.
4.7 across 614 public reviews on Google, Trustpilot and Avvo.
#1Top reviewed IP law firm*
Read client reviews“Andrew Rapacke and his team are exceptional. They did our provisional and non provisional patents. The entire team is professional and an ease to work with.”
Von DorjevskiFounder, Inguardia Health · Client review “I can safely trust them with scientific and legal integrity regarding ownership and accountability of inventions.”
Hussain AtherPatent · Client review “Their writing allowed for protection of my invention's most important aspects, as well as giving me room to modify and adapt my product.”
Andrew WebberProvisional patent · Client review
Reviews reflect individual client experiences. Quotes are excerpts. Prior results do not guarantee a similar outcome. *#1 top reviewed means the most public client reviews on Google, Trustpilot and Avvo of any US patent or trademark firm.
Protect the device before you show it.
Talk through your device with a registered patent attorney. The call is free, with no obligation.