Medical technology encompasses devices and equipment that have been invented to innovate medical processes, speed up disease detection time, and enhance recovery and treatment. It also includes medicines and vaccines, biotechnology and information technology, and the processes and systems used in medical care. Essentially, medical technology prolongs our lives and improves quality of life through preventative care and diagnosis and treatment of illnesses.

Medical technology can be used by doctors, nurses, lab technicians, pharmaceutical manufacturers, or even patients in their own homes. There is a specific career field for Medical Technologists, who must earn a Bachelor of Science degree.

If you have invented or designed a product for use in the medical field and wish to bring it to market, there is a whole host of considerations you need to take into account.

What are Some Examples of Medical Technology?

Medical technology includes devices, such as medical scanning machines, but it also includes much more. “Smaller” innovations such as bandages and braces are, nevertheless, technological advances.

Vaccines used to prevent illnesses, new medicines developed to treat them, the information technology used to store medical records and transmit them and surgical processes and procedures are all examples of medical technology, because they all allow for the improvement of length and quality of life. Below is a non-exhaustive list of examples of medical technology:

  • MRI scanners;
  • Microscopes;
  • Computers;
  • Heart monitors;
  • Artificial organs and limbs (prosthetics);
  • X-ray machines;
  • Adhesive bandages;
  • Pharmaceutical;
  • Vaccines;
  • Surgical procedures; and/or
  • Patient portals.

What Do Medical Technologists Do?

Medical technologists complete a Bachelor of Science degree in order to work in their field. They perform a range of medical tasks that involve medical technology. Tasks 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; and/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 for doing so. Before a device is even ready for sale, it must go through multiple steps.

  1. Design: You must first design your concept. This may include conducting research, drafting plans, and experimenting with different methods.
  2. 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. 
    1. If not, you can apply for a patent through the U.S. Patent and Trademark Office. This will protect your intellectual property by prohibiting others from replicating your design and profiting off of it.
  3. Construction: Now you need to actually build your medical device. You will need to find parts suppliers, manufacturers, and distributors. You may also need to obtain capital to finance the manufacture and distribution of your medical technology.
  4. Regulatory Approval: Depending on the type of equipment, you will likely need to have your product tested and approved by a federal regulatory agency. 
    1. This requires filing paperwork, undergoing inspections, and awaiting approval before selling your medical technology.
  5. Sales: After receiving regulatory approval, you are ready to sell your product! Now you need to market the product, procure sales, and deliver the product.
  6. Maintenance: After a sale has been processed, you need to have a system in place to deal with device failure and other customer service issues. 
    1. You will want engineers trained to fix faulty equipment or address other issues that arise from operating the medical technology.

How Does Medical Technology Relate to the Law?

The Affordable Care Act, implemented in 2010, included regulations which impacted the medical technology field. The focus on preventative care and health and wellness practices improved the market for technology devices that keep healthcare consumers well, meaning, devices that allow for illness prevention (specifically, chronic illnesses), devices that can be used by the consumer themselves, 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 primarily deals with patient privacy. When considering the creation of new medical technology, it is very important to also consider the effect it will have on patient privacy. A device or other type of medical technology that would violate HIPAA laws is unlikely to be very marketable.

Do I Need a Lawyer If I Have Invented a Medical Device?

If you have invented a medical device, you should consult with an intellectual property lawyer who can help you patent your product and defend against patent trolls.

The laws regarding medical technology patenting are extremely complex. Other medical device manufacturers are constantly 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 person can navigate with ease.