Since the introduction of the first medical device (such as forceps, knives, scalpels, saws, lancets, needles, trocars, cauteries and knives for several medical procedures) a few thousand years ago, the medical industry has experienced rapid growth. The emerging 5G technology will make smart medical devices more accessible and provide users with better experiences. It offers faster data speeds and lower latency. It can be difficult to predict the future of medical device technology.
As a patent attorney who has helped many startups patent their medical device inventions, I know that many unicorns will come out of the space. It is important for medical device founders to implement IP protection to ensure their plans to go to market are not disrupted by first that quickly follow a first-to-market leader. For medtech founders, here are the trends in securing patent protection for medical devices.
Medical Device Tech Trends
Medical device technology is a rapidly evolving field, with new developments and innovations emerging all the time. Here are some potential forecasts for the future of medical device technology:
- Increased use of wearable technology: Wearable medical devices, such as smartwatches, will become increasingly popular for monitoring and tracking vital signs, such as heart rate, blood pressure, and sleep patterns.
- Advancements in telemedicine: Medical devices will be used more often in conjunction with telemedicine, which allows patients to communicate remotely with healthcare professionals, enabling remote monitoring and diagnosis.
- Greater use of artificial intelligence (AI) and machine learning (ML): Medical devices will increasingly incorporate AI and ML technology to improve accuracy, speed, and efficiency in diagnostics and treatment.
- Increased use of 3D printing: 3D printing technology will be used more frequently to create custom medical devices and implants, such as prosthetics and orthotics.
- Advancements in minimally invasive procedures: Medical devices will continue to evolve to make procedures less invasive, reducing recovery time and improving patient outcomes.
- More focus on remote monitoring and patient self-management: Medical device technology will increasingly be used to enable patients to monitor their own health and manage chronic conditions from home.
- More use of connected devices: With the growth of IoT, medical devices will be connected to share information and provide real-time monitoring of patient’s health, which will help in remote diagnosis, and treatment.
- Advancements in implantable technology: Implantable devices will continue to evolve, with more compact, wireless designs and longer battery life, making it more comfortable for the patient and reducing the need for frequent replacements.
These are some of the potential forecast for the future of medical device technology, but as technology and medical research continue to evolve, it is likely that new developments will emerge.
Patents play an important role in the medical device space by providing exclusive rights to the patent holder to prevent others from making, using, and selling the patented invention. This exclusivity allows medical device companies to recoup the costs of research and development and invest in the creation of new and innovative products. Additionally, patents can also provide a competitive advantage by preventing competitors from copying the invention. However, patents can also limit access to medical devices by making them more expensive for patients and healthcare providers.
Medical device Patent Cost
Costs for patenting a medical device vary depending on many factors such as the app’s complexity, the patent sought and attorney fees. These are just some estimates of the cost to obtain a patent for a medical device:
- Patent Search: Depending on the complexity and scope of the application, a patent search can run from several hundred to several thousand dollars.
- Patent attorney fees: Depending on the complexity of an app and the attorney’s expertise and experience, patent attorney fees can be anywhere from a few thousand dollars up to tens or thousands of dollars.
- Patent application fees: Fees for patent applications vary depending on what type of patent is sought. Utility patents are typically more expensive than design patents. The USPTO charges for a non-provisional utility application are approximately $900 for small entities and $1600 for large companies.
- Maintenance fees: To keep a patent in force after it is granted, maintenance fees are due. After grant, the fees will be due in three years, seven and eleven years.
- International fees: Additional fees may be charged if the application is to be filed in another country.
Patent attorney fees make up the largest portion of the total cost so we have broken down the fees according to patent type:
A provisional patent application for a medical device has several advantages, including:
- Early priority date: A provisional patent application establishes an early priority date for the invention, which can be important in cases where there may be potential infringement by others.
- Low cost: Provisional patent applications are less expensive to prepare and file than non-provisional applications.
- Flexibility: A provisional application provides the flexibility to later convert the application to a non-provisional application, allowing more time to further develop and/or test the invention.
- Patent pending status: A provisional patent application allows the inventor to mark their invention as “patent pending,” which can provide a competitive advantage in the marketplace.
- Test the water: it can be used as a way to test the water for the invention, for example by disclosing it to potential licensees or investors without incurring the cost of a non-provisional application.
Overall, a provisional patent application can be a useful tool for inventors of medical devices, as it provides a way to protect their invention at a relatively low cost and with a degree of flexibility.
A provisional patent is a smart investment before you market your invention. This gives you the status “patent pending” which protects your ideas. A patent attorney can charge anywhere from $3,000 to $10,000.
A non-provisional patent application for a medical device is an application that includes a full and complete disclosure of the invention, including any and all details necessary for someone skilled in the art to make and use the invention. The main advantage of filing a non-provisional patent application for a medical device is that it provides the strongest possible protection for the invention.
- Exclusive rights: Once a non-provisional patent application is granted, the patent holder has the exclusive right to make, use, and sell the invention for a certain period of time (typically 20 years from the date of filing).
- Legal standing: Having a non-provisional patent gives the holder a stronger legal standing in case of patent infringement lawsuits.
- Licensing opportunities: A non-provisional patent can be licensed to others for a fee, which can provide a source of revenue for the patent holder.
- Investment: A granted non-provisional patent can also be used to attract investment for the device or company.
- Competitive advantage: A granted non-provisional patent can give the holder a competitive advantage over other companies, by providing a legal barrier to entry for others to make, use, or sell a similar device.
It is important to note that filing a non-provisional patent application is a complex process that requires the help of a patent attorney. Additionally, even after filing a non-provisional patent application, there is no guarantee that the patent will be granted, as the application must pass through an examination process by the patent office to ensure that it meets all requirements for patentability.
If you want to apply for patent protection, you will need to file a not-provisional request. This must be filed within one year of filing for a provisional patent or an equivalent. Depending on the complexity of the application, it will cost between $10,000 to $20,000
GUI Design Patent
Startups find it equally important to protect the ornamental look of the medical devices, and in case the device includes software, the ornamental design of their software interface. A design patent can help you do this. It is smart to combine your utility patent application with your design patent. This protects your software’s functionality as well as its appearance. An experienced patent attorney can assist you in drafting your application for a design patent. The cost of the application for a design patent can range from $2,000 to $5,000
These costs are only estimates. Actual costs will vary depending on the details of each case. To get a precise estimate of the cost to obtain a patent for a medical device, it is a good idea to consult a patent attorney.
What makes patenting a medical device so expensive?
Patenting a medical device can be an expensive process due to several factors, such as:
- Complex technology: Medical devices often involve complex technology and may require a deep understanding of medical and engineering principles to fully understand and explain the invention. This can require significant time and effort from the patent attorney to draft and prosecute the patent application.
- Prior art search: Conducting a thorough prior art search for a medical device can be time-consuming and expensive, as it often involves reviewing a large number of patents, publications, and other sources of information, especially when the device is part of a new technology or field.
- Testing and validation: Medical devices typically require testing and validation to ensure that they are safe and effective for their intended use. This can be a time-consuming and costly process, and the results of these tests may need to be included in the patent application.
- Attorney’s fees: Patent attorney fees can range from a few thousand dollars to tens of thousands of dollars, depending on the complexity of the device and the attorney’s experience and expertise.
- Patent application fees: Patent application fees vary depending on the type of patent sought, with utility patents typically costing more than design patents. The USPTO fees for a non-provisional utility patent application is around $300 to $600.
- International fees: If the application is going to be filed in other countries, additional fees will be incurred.
It’s important to note that these costs are estimates and the actual costs can vary widely depending on the specifics of the case. It is always recommended to consult with a patent attorney to get an accurate estimate of the costs involved in obtaining a patent for a medical device.
How do you choose the right patent attorney?
A medical device patent attorney can save you money when applying for patent protection. An expert in medical device patenting will be able to give guidance about the patentability and best way to claim it. Here are some of the ways that the right domain expert patent attorney can help you save money.
- It is cost-effective: A medical device patent attorney will be able conduct a thorough search of the prior art, identify potential obstacles and draft the patent application so that it maximizes its chances of being granted. This can help you save money over the long term.
- Prosecution: An expert in medical device technology and patent law will handle prosecution of the patent application. This can help to save money and time.
- Licensing & Monetization: An expert in medical device patent law will be able provide guidance regarding licensing and monetization strategies, which are specifically tailored for the medical market. This can help generate revenue from the patent.
- Legal disputes: An attorney who is skilled in medical device and patent law will be able advise you on possible infringement issues and help you to take legal action to defend the patent. This can often save money over the long-term.
Patent attorneys with experience in medical devices can help inventors increase their chances of getting their patent applications granted. They also ensure that their patent is properly protected, monetized and maintained. This will save them money.
start Your medical device patent application now!
Investors are often attracted to medical devices that have both FDA approval and patent status. Patents grant the company exclusive rights to the invention and prevent others from using it or selling it without permission. This can help companies recover development costs and FDA clearance. FDA approval also proves that the device meets the strict standards of safety and effectiveness set by the FDA and can legally be sold and marketed in the United States.
FDA approval can give a company an advantage in the marketplace, because it provides a legal framework for marketing and selling their products. Potential investors have this assurance that the product is safe and has been properly vetted.
A patented, FDA-approved medical product can help a company stand apart in a competitive market. This can help increase its chances of success, and in turn attract more investors.
FDA clearance allows the company to expand internationally and enter new markets. The device is already approved for use in the United States, where there are some of the strictest regulations in the world.
Medical devices that have received FDA and patent approvals are considered more attractive investments because they give you exclusive rights to the invention and legal framework to market it. They also provide a level of safety and security to use.
The timing of when to file a medical patent application depends on many factors. These include the stage of development, industry competition, and company’s overall business strategy. These are the things you should consider when making the decision to file a medical device patent application.
- Timing of development: It is a good idea for patent applications to be filed as soon as possible. This should be before the app is published or disclosed publicly. In many countries, like the United States, the inventor has a one year grace period following the first public disclosure of an invention before they lose their right to patent it.
- When deciding when to file a patent application, it is important to take into account the competitive landscape. It may be beneficial to begin the patent application process early if there are similar patents or apps in the same field.
- When deciding when to file a patent application, it is important to consider the company’s business strategy. If the company intends to make revenue by licensing the app it is important to begin the patent application process as soon as possible to ensure that the patent is granted before the app goes public.
- Provisional application: You can file a provisional application before you submit the final application. This will give you an earlier priority date and allow you to work on the app more efficiently.
The timing of when to begin the medical device patent application process depends on the particular circumstances of the app and company. It is important that you consult with a patent attorney in order to determine the best course.