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The Evolutional Patenting of Medical Devices
By Kfir Luzzatto
Israel is well known as the cradle of many successful developments in the field of medical devices in various medical areas. Stents, cameras that travel within the body and devices that map the activity of the heart, or which generate thin-sliced images of the human body, all have deep roots in the local industry. It is therefore surprising to discover, time after time, that many companies that are deeply involved in the R&D of medical devices take a disjointed approach to the patenting of their results.
A number of factors converge to render the patenting process in this field more difficult than in others, the first of them being the identity of the players. One of the reasons why the Israeli R&D in medical devices yields impressive results is that most of (if not all) the teams developing innovative approaches work in small start-up companies. The environment in which they operate, which is free of organized R&D methods and strategies and which often looks chaotic, supports and encourages the emergence of new ideas, often resulting from a non-hierarchical interdisciplinary cooperation that forces the participants to live in perpetual brainstorming. The result is a fast-paced unconventional R&D program that could never take place in a well-organized and disciplined company. Following this path, many start-up companies disappear in the wake of their self-inflicted chaos, but the ones that survive often produce impressive results. The question is, however, whether the results of the R&D process, which are often groundbreaking, have been afforded proper patent protection. Sadly, this is too often not the case.
Inventors all over the world, and most particularly in Israel, have a tendency toward sparking patenting efforts when the idea strikes their fancy, and then forgetting all about it until and unless forced to deal with it again. Unfortunately, chances are that the moment chosen by the inventor to address patent issues will not be the most appropriate one. After the patent ritual is taken care of, the inventor, more often than not, lies back in satisfaction and never wants to hear about patents again. This approach to patent issues may perhaps work with “one off” inventions, where the whole inventive idea is already fully developed at the outset, but this is almost never the case with medical devices.
Let’s take, for instance, the development of a minimally-invasive surgical device. It typically starts with an idea that someone in the medical profession had, that a particular surgical procedure could be carried out in a better and less shocking way by building a device possessing certain capabilities. The inventor, who is normally not a technical person, then finds an experienced engineer (if at all possible, a close friend or relative) who grows excited with the idea. Now we have a core for the startup company.
The first stage of the new development is usually marked by feverish brainstorming, optimistic drawings of magically bending and smoothly operating parts and, of course, calculations of future market shares that start at a conservative one or two billion mark. At this point the entrepreneurs realize that, if they want to pursue their idea and obtain financing, they must get some sort of patent protection. They thus proceed to file a patent application, covering the concept of their device and its many marvelous uses, and start the ball rolling. Then, as said, chaos ensues and the patent process is forgotten. Lulled into a state of false security by the filing of their preliminary patent application, they develop, and develop, and develop...
As many inventors must learn from their own bitter experience, their “basic concepts” are often not the real inventions that make their device tick. When we dig deep under the surface we may find that others have played with those concepts before but have never translated them into a practical result. This is due to the fact that there is much more to a working medical device than a basic concept, and most often the really important inventions reside in the solution of seemingly small technical problems, without which a working medical device may never come into existence.
A joint that doesn’t bend well enough has to be redesigned? We may have an invention. Conventional cleaning methods, to keep a lens clean within a body lumen, are not good enough in our configuration? We must invent a new one. Did we have to redesign the user interface to make it possible for the surgeon to carry out a particularly delicate manipulation? Invention! The patenting process must go hand in hand with the R&D process. Inventions must be identified “on the fly” and their importance to the final product must be evaluated. Appropriate patenting policies must be put in place for different types of inventions and levels of importance. All this is not new ground for patent practitioners; on the contrary, this is how the patenting process should be carried out. However, operating in this way requires a methodical approach to the issues, which, in many cases, is viewed as a nuisance by the inventors.
It is the passionate approach to the development of the medical device and the unbelievably hard work required of the inventors that leads to the technical success. It is the same approach that, paradoxically, may lead to a failure to protect that very same success efficiently. Start-up companies that have overcome this hurdle all have a clever management and realize that the persons in charge of planning the patenting process cannot be those involved in the development of the product. They must be able of independent thinking, unbiased by personal considerations, and must be receptive to the sound advice of experienced patent practitioners. Other routes have been known to lead to perdition.
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