Insights
Practical writing for people who build medical devices, from someone who has built them.
These articles cover the questions device inventors actually ask, written by a registered U.S. patent attorney who is also a mechanical engineer and a medical device inventor. Every one of them comes from a conversation that has happened more than once.
- Getting Started
How a Physician Patents a Medical Device
The step-by-step path from a clinical idea to a filed application, for a clinician with a full schedule and no engineering department.
- Filing
You Do Not Need a Prototype to File
U.S. law lets a sufficiently detailed application stand in for a working device. Here is what the application has to teach instead.
- Ownership
Does Your Hospital Own Your Invention?
Probably not by default, and possibly yes by contract. The answer is in documents you signed and may not remember.
- Regulatory
510(k) Clearance and Patent Timing
Clearance lets you sell and protects nothing, and the 510(k) process publishes your device on a schedule you do not control.
- Software
Patenting Software Inside a Medical Device
Control logic, signal processing, and alarm rules are patentable when the claims recite the technical improvement rather than the result.
- Drafting
What Goes Into a Medical Device Patent Application
Specification, drawings, claims, abstract, and the formal papers. What each one does, and what only the inventor can supply.
- Timing
When Should a Device Inventor File?
The instinct is to wait until the design is finished. In device development, that instinct is usually wrong.
- Devices
Patenting a Surgical Instrument
Surgical instruments look like crowded prior art until you realize what actually gets claimed.
- Strategy
Design or Utility Patent for Your Device?
They protect different things, cost different amounts, and the strongest device positions use both.
- Regulatory
Does FDA Clearance Protect My Device?
No. Clearance is permission to sell. It gives you no right to stop anyone else from selling the same thing.
- Digital Health
Patenting Software as a Medical Device
SaMD sits at the intersection of two hard problems: Section 101 eligibility and a regulatory pathway that publishes.
- Deadlines
Showing at a Trade Show? Read This First.
A booth at MD&M or AAOS is a public disclosure. Here is what to do in the weeks before it.
- Ownership
Physician Inventors and Who Owns the Device
Your employment agreement and your institution's IP policy may already have answered this. Find out before you file.
- Strategy
Can You Actually Sell Your Device?
Whether you can patent your device and whether you can sell it are different questions with different answers.