The Road to MedTech Innovation: Conception, Valuation and Protection
Physicians with expertise in their field of practice often have plenty of novel ideas, but they are not sure how to evaluate the validity of them or how to develop them into patient care products. Ideas are the start of every innovation.
However, many factors must align for an idea to become a marketable product, including the availability of the technology needed for its development, the interest of the end user and payers, the market size and expected revenue, as well as the spending priorities of the healthcare system.
This article will go over the process of evaluating the novelty of a new idea and protecting the inventor’s rights, while subsequent articles of this series will focus on the other steps needed to develop a novel idea into a marketable healthcare product.
Conduct a General and Intellectual Property Search
First, you should find out if your idea has already been developed by someone else in the past, and if not, whether you can own it. Inventors should start by performing a general internet search to look for similar products in development by others.
The next step is to perform an intellectual property search using a web engine such as the U.S. Patent and Trademark Office (USPTO) database, the European Patent Office (Espacenet), or Google Patents. The patent document is quite wordy and complex; however, one can identify the main characteristics of an invention by reading the claims section and reviewing the included drawings.
Another component of the patent search is related to the “freedom to operate,” which is concerned with whether your idea has been conceived in the past and marketed for other purposes.
For example, if you have invented a medical instrument that functions in a way similar to a previously patented aerospace device, then you might have to reach out to the entity that holds that patent and obtain a “freedom to operate” letter after you have filed your patent.
This type of search is labor intensive, costly and usually requires the help of an experienced patent attorney. The good news is that a freedom to operate search is typically not required until the later stages of product development.
Protect Your Rights
Filing a patent claim is the standard process used to protect the legal rights of the inventors and their institution. The USPTO allows an inventor to submit a preliminary version of the patent, called a “provisional patent,” that serves as a placeholder for priority date, with an understanding that a non-provisional patent claim will be filed within a year to keep the initial priority date.
While a provisional patent is a simple document describing the art and can be prepared by the inventors, writing a non-provisional patent application is more complex and should be prepared by a patent attorney.
Many inventors prefer to involve a patent attorney early in the process to prepare a comprehensive provisional patent document that is similar to a non-provisional patent and can be easily converted to one. Inventors may decide to file an international patent to protect their rights in other countries based on their needs and after studying the cost effectiveness.
If the inventors’ institution decides to preserve its rights and file the patent on behalf of the inventors, the institution usually pays for the expenses and will be listed as the “assignee.” Otherwise, the inventors can request a “release of rights” to file the patent independently.
The patent office will evaluate the patentability of the invention based on three main components: novelty, none-obviousness and usefulness. Inventors should consult with their technology transfer office for advice before discussing their invention with other individuals to address the need to have a signed non-disclosure agreement (NDA) in place.
Inventors should refrain from discussing unprotected ideas in any public format (lecture, journal publication, etc.) as this can result in their inability to file a patent claim in the future.
In summary, ideas are valuable assets, but they constitute only one element in the complex process of technology development. It is crucial to establish the novelty of an idea and take the right steps to protect it before spending the time and effort needed to develop it.
Your idea might have been conceived by someone else in the past but failed to make it to an advanced stage due to the lack of interest, inadequate skills and resources or technology shortcomings at that time.
If you think your idea is novel, feasible and fulfills an unmet need to a sizable group of patients, you should proceed with the next step in evaluating your idea as a potential marketable product.
This article was authored by Ahmed M. Selim, MD, an FIT at New York University. Twitter: @DrAhmed_Selim.
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