Medical technology encompasses devices and equipment that have been invented to innovate medical processes, speed up disease detection time, and improve recovery and treatment. It also includes medicines and vaccines, biotechnology and information technology, and the methods and systems used in medical care.
Basically, medical technology extends our lives and enhances our quality of life through preventative care and diagnosis and treatment of illnesses.
Medical technology can be used by physicians, nurses, lab technicians, pharmaceutical manufacturers, or even patients in their own houses. There is a specific job field for Medical Technologists, who must earn a Bachelor of Science degree.
If you have created or developed a product for use in the medical field and wish to bring it to market, there are many concerns you need to take into account.
What Are Some Examples of Medical Technology?
Medical technology includes devices, such as medical scanning machines and much more. “Smaller” innovations such as bandages and braces are technological advances.
Vaccines used to control illnesses, new medications designed to treat them, the information technology used to stow medical records and transmit them, and surgical processes and procedures are all examples of medical technology. They all allow for the advancement of length and quality of life.
Below is a non-exhaustive list of examples of medical technology:
- MRI scanners;
- Heart monitors;
- Artificial organs and limbs (prosthetics);
- X-ray machines;
- Adhesive bandages;
- Surgical procedures; or
- Patient portals.
What Do Medical Technologists Do?
Medical technologists complete a Bachelor of Science degree to operate in their field. They perform a range of medical tasks that involve medical technology.
Duties for medical technologists include:
- Blood work;
- Pregnancy tests;
- Conducting scans such as those done with an MRI or X-ray machines;
- Producing lab results using microscopes and other lab equipment; or
- Analyzing lab results.
What Is the Process for Creating a Medical Technology Device?
If you are interested in producing medical technology, you should understand the process. Before a device is even ready for sale, it must go through multiple steps.
- Design: You must first create your concept. This may include performing research, preparing plans, and experimenting with different methods.
- Patenting: Once you have come up with your final design, you need to patent your product. First, search to see if someone has already patented the same design. If not, you can apply for a patent through the U.S. Patent and Trademark Office. This will defend your intellectual property by restricting others from replicating your design and profiting from it.
- Construction: Now, you need to build your medical device. You will need to find parts suppliers, manufacturers, and distributors. You may also need to acquire capital to finance the manufacture and distribution of your medical technology.
- Regulatory Approval: Depending on the type of equipment, you will likely need to have your product tested and approved by a federal regulatory agency. This requires filing paperwork, undergoing inspections, and awaiting permission before selling your medical technology.
- Sales: After receiving regulatory approval, you are ready to sell your product. You need to market the product, procure sales, and deliver the product.
- Maintenance: After a sale has been processed, you need to have a system to deal with device failure and other customer service issues. You will want engineers trained to fix faulty equipment or address other issues from operating the medical technology.
How Does Medical Technology Relate to the Law?
The Affordable Care Act, implemented in 2010, included regulations that impacted the medical technology field. The focus on preventative care and health and wellness practices enhanced the market for technology devices that keep healthcare consumers well, meaning devices that allow for illness prevention (specifically, chronic illnesses), devices that the consumer themselves can use, and devices that prevent their needing admission or readmission to hospitals.
Another legal concern with medical technology revolves around the Health Insurance Portability and Accountability Act, or HIPAA. This mainly deals with patient privacy. Regarding creating new medical technology, it is also important to consider its effect on patient privacy. A device or other medical technology that would violate HIPAA laws is unlikely to be very marketable.
What Is Patent Inventorship?
The word “inventorship” is a word of art, making an exact definition somewhat tricky. Inventorship describes the quality of a person who invents or discovers any “new and useful process, the machine, manufacture, or composition of matter,” or any new and useful improvement of any of the following.
Why Is Inventorship Important?
Inventorship is essential because, unless the inventor assigns their rights to another individual, only the actual inventor can apply for the patent. So, when you file for a patent, you have to be sure that you know who holds inventorship in the invention.
Who Holds Inventorship?
Although this question seems straightforward, it becomes pretty complex in the context of an employer-employee relationship. Usually, an employee holds inventorship in the invention as long as the employee conceived of it and reduced it to practice on their own time. However, there are certain exceptions to this rule:
- Express agreements: This happens when the employee signs an express agreement to assign all rights to inventions created by the employee during their employment to the employer.
- Implied agreements: Even if there was no written agreement, an employer might own the rights to the invention if the employee was employed to invent the product or process or to solve the problem.
- Shop rights: Even if the employee owns the rights to the invention, the employer may have a limited “shop right,” meaning that they have the right to use the design without the approval or payment of the employee. Shop rights usually come up when an employee uses an employer’s resources to develop an invention.
Can There Be More than One Inventor?
Patent law allows more than one individual to apply for the same patent. If more than one individual contributes to the invention, patent law requires that each individual be named in the application.
Nevertheless, joint inventorship demands both contribution and collaboration:
- Contribution: Each individual must have contributed to the conception or reduction to the practice of an invention. It is not enough to supply resources or explain an existing concept. Each individual must make an inventive contribution.
- Collaboration: Each individual must be aware of the others’ assistance and must have planned to work together to create the invention.
Each inventor does not have to contribute the same amount or make their contribution simultaneously. As one can imagine, this can cause disputes among inventors, which may be relieved by defining the invention with precision. Therefore, as long as there is contribution and cooperation, each individual is a joint inventor and has the right to exercise all patent rights.
Do I Need a Lawyer If I Have Invented a Medical Device?
If you have invented a medical device, you should consult with a U.S. patent lawyer who can help you patent your product and defend against patent trolls.
The laws regarding medical technology patenting are highly involved. Other medical device manufacturers are always innovating and looking for new revenue sources, and you want to protect your design from these competitors. U.S. patent law is not a field that the average individual can navigate easily.