At Smith & Hopen, we foster growth in the Medtech Field through innovative Intellectual Property (IP) Strategies, Patent Prosecution, and IP Litigation to help Medical Device Startups speed the protection of their inventions, attract critical investment, and secure market advantage.

Smith & Hopen’s patent prosecution and counseling team has over 20 years of experience in patent prosecution, IP strategy, and litigation for complex Medical Device technologies. Members of the team hold advanced degrees in scientific disciplines such as mechanical and electrical engineering, biomedical and chemical engineering, and biology, among others.

Currently, we represent medical device design firms, emerging high-growth startups, universities, surgeons, physicians, and privately held companies.

Representative Technologies:

  • Medical Imaging, including Mammography and Laparoscopic Camera Systems
  • Blood Glucose Monitoring Systems
  • Wound Simulation Visual Overlay
  • Multisensory Wound Simulation
  • Bioabsorbable Sealants
  • Method for Automated Discrete Medical Images, such as CT scans

Patents – Medical Devices – Frequently Asked Questions (FAQ):

1. What qualifies for a medical device patent?

In order to qualify for a patent, your claimed invention must be novel, useful, and non-obvious.

2. Do I own rights to my medical device invention?

It depends, if you work for an academic institution, you may have an Intellectual Property Assignment clause in your contract. If that is the case, the university may actually be the owner of your claimed invention. Moreover, if you have worked with several other physicians or researchers, determine if they also contributed to any part of the claimed invention. Based on their input, they may also be partial owners of your claimed invention.

3. Is my Medical Device Patentable?

Only novel, useful, and non-obvious inventions can be patented.
By conducting a Patentability (Prior Art) Search, you can determine what has already been patented and is currently available to the public.

4. What type of patent protects the medical device?

As a medical device manufacturer or designer, you will most likely need either a utility patent or design patent.
A utility patent protects your invention’s process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.
A provisional patent may be used to “hold your place in line” before you’re ready to file an official utility patent. Filing a provisional application for a medical device gives you a year from the provisional application’s filing date to begin the patent application process.
A design patent protects the exterior design or “look” of the medical device (e.g., shape of the device; user interface; design of the touchscreen).

5. How can I secure funding for my medical device development?

Venture Capital and Private Equity Firms have been increasingly entering into the medical device space. In 2020, alone, Medtech Startups received $6.4 billion in venture funding, a substantial increase from the $5.7 billion Medtech Startups received in 2019.
By conducting a Freedom-to-Operate (FTO) Analysis for your technology, you can provide Venture Capital and Private Equity firms the needed confidence to invest your Startup Company and Technology.

6. Do I need FDA approval to file a medical device patent?

You are not required to have FDA approval before filing for a patent.

7. Do I need FDA approval to sell my medical device?

FDA Approval is required to commercialize and market your medical device in the United States.
FDA categorizes medical devices into three distinct classes: Class I, Class II, and Class III. Getting FDA approval can be time-consuming and costly. That’s why it is critical to make sure you have the appropriate amount of funds to not only apply for approval but also to begin marketing your medical device after you receive FDA approval.

8. What can I do with my medical device patent and FDA approval?

After you have gotten your patent and FDA approval, you are able to exclusively manufacture and distribute your medical device. Additionally, you are able to sell or license the rights to your patent to a third-party corporation or individual.

With a team of highly-skilled patent attorneys, we are always in a position to achieve optimal results for our clients. Get in touch with us today to secure your rights and your place in the Medtech Market.