David Foshee, Principal Design Engineer, Gilero LLCAs a medical device design and development consultancy, Gilero has worked with a number of clients who have conceived of an idea for a new medical device on their own, and are interested in learning how to bring their concept to market. Ideally there are two things to have that will set you on the path to a new medical device product; a patent and a working prototype. The patent declares that the idea is novel and implies that you will be able to reap the exclusive rewards of its sale for twenty years or so. Of course this is predicated on the idea that there are rewards to be reaped (i.e., your device does something that people will be willing to pay for) although one has to admit that the Pet Rock phenomena set a pretty low bar here. Having established your rights to the idea, the working prototype demonstrates to potential investors exactly what your invention does and how it does it. Taking a device idea through to market requires a lot of money and most individual inventors will require investors to go the distance.

The first step to securing your intellectual property should be to check and see if someone else already has a patent on it. Searching patents can be pretty easy using tools like Google Patents or the USPTO website. Simply enter a search term based on your concept and see what pops up.  Reading the description and looking at the figures should give you an idea of what the patent is about.  Once you find one patent in the general vicinity of your idea, you can start looking at the listed patent citations and references, typically on page one, to lead you to other relevant patents. The most important part of a patent are the claims, because these specifically and legally define exactly what ideas the patent protects. Unfortunately these may not be very easy to understand due to a couple of centuries of legal professionals developing their own patent language, and the desire to make every statement as broad and non-exclusive as possible. You might see something like this: 

A fluid transfer device comprising: a housing adapted to receive a fluid container and a media container; and a flow controller having an interior and an exterior, the flow controller at least partially slidably disposed in the housing, the flow controller comprising at least one fluid channel and at least one vent conduit.

With a little forensic dissection of the pictures and the appropriate pharmaceutical augmentation, you may eventually figure out what they mean. At this stage you can safely ignore some of the non-exclusive language, since after all everything bigger than an electron has “an interior and an exterior.” A good rule of thumb is to list all the features that the claim says the device has in it. If your device has all of the elements in the claim, it is covered by the claim, even if you have other elements in addition to those. If your device has some but not all of the elements in the claim, then it is considered novel. Better yet your idea may not resemble any patented device that you see.

Once you have checked around a bit and feel confident that your idea is novel, you can move on to creating your own patent. While theoretically you can do this yourself, it is marginally more complex and risky than performing your own appendectomy, so I would recommend hiring a patent attorney. Since it takes a long time to write a patent that no one can understand, and since attorney’s charge by the hour, it is often more expedient to begin with a Provisional Application.  

The Provisional Application is a mechanism offered by the United States Patent and Trademark Office that allows you to disclose your idea to the USPTO with a written description and any drawings necessary to explain it, and establish a filing date. A provisional application is far quicker and therefore less expensive to create than a full patent application. After submitting a provisional application, you have one year to make a full patent application. During this period your idea is protected and you are allowed to use the term Patent Pending in connection to the description of your invention.

In parallel with establishing your Intellectual Property, creating a working prototype to embody your invention is critical. A working prototype will demonstrate to any interested parties that your idea is feasible and realistic. If a picture is worth a thousand words, a prototype is worth, well, a lot more. Nothing beats holding a working device for communicating your product vision. Ideally your prototype will be as close to your vision of the final product as possible in terms of robustness, functionality, and appearance. Again, theoretically you may be able to build your own prototype, but since working with unfamiliar power tools may lead to a spontaneous, self-inflicted “ectomy” of indiscriminant nature I would recommend hiring a design firm for this task. There are many prototyping materials and methods to choose from and having an experienced team managing the process can save a lot of time and money while producing optimal results.

With a working example of your excellent invention and established intellectual property protecting your rights to it, you will be ready to win the support and forge the partnerships necessary for bringing your idea to market.

[Editor’s Note: Look to the July/August issue of MDT for more “Perspectives” on how to get started with a medical device idea. Or just watch for them to be posted as blogs later in August.]