SURGEON AS ENTREPRENEURThe Long and Lonely Road:Life as a Surgeon InventorAuthor: Ron Clark, M.D.In 2005 I founded Valpo Orthopedic Technology in order to commercializemy inventions. This year marks the release of its first product, the Adjust-Rite tibial ligament fixation system. Time and clinical outcomes willdetermine the utility and success of this device.Many are intrigued by the process that leads to new medical devicedevelopment, and believe that they too have concepts that can lead toimplants or instruments. Perhaps this review will motivate another apt andcreative mind to begin the path towards such a prospect. Most of what Ihave learned has come from my experiences, and I couldn’t say whetherthey are likely to be typical for others. What I will say is that most surgeoninnovators are by nature “independently minded,” and don’t necessarilycollaborate well with other surgeons. Many implant companies attempt toorganize committees of renowned surgeons to bring new ideas to market.It seems that a greater number of surgeons assigned to a given task willultimately prolong the project. Many such committee projects are neversuccessfully launched. Some companies bypass the surgeon developercompletely, opting instead to sample surgeons for device enhancementideas and tasking engineers with the creative and developmental responsibilities.Unknowingly, many surgeons give millions of dollars away todevice companies through disclosures that are not properly protected anddocumented.The best advice that I ever received about device development camefrom my fellowship director, E. Marlowe Goble of Utah. He told me thatan idea without a patent to describe it is worthless, and encouraged me topatent any concept that I wanted to explore and develop into a device.What one quickly learns, however, is that not only are patents expensive toacquire and maintain, but they do not of themselves lead to businesssuccess (unless your name is Gary Michelson). Aside from getting yourconcept patented, you will need to have a working prototype and apathway for FDA clearance worked out in advance. The problem withnovel devices is that until you can actually put a few in and try them out,a number of things can go wrong and the device will always need revision.Therein lies the problem with working with a technology that is licensed,because as others gain experience with its deficiencies, further creativityinitiates solutions that obsolete the licensor’s novelty. On many occasions,I’ve ultimately found myself competing against myself due to innovationsto concepts that I originally conceived, such as cross pin femoral ligamentfixation for hamstring tendons that Dr. Goble and I developed in 1992.This technology has all but been rendered obsolete by a productsubsequently marketed by one of the sports medicine companies.I have observed that the most successful orthopaedic surgeon inventorsend up forming and owning their own development companies. You canlearn a lot by getting to know them, and I have found them almost alwayswilling to share something they learned along the way. To be certain, mostsurgeons are jealous of one another and prefer to work without collaboration,which is probably why industry executives outperform orthopaedic surgeonseconomically—because they have learned how to work with people ratherthan against them. Surgeon names like Bonutti, Steffee, Johnson and Pettyhave all done well in building viable enterprises around them.Unfortunately, even successful surgeon inventors watch others profitfrom their creative endeavors as venture capitalists and industry managerscome into the picture and thus dilute the surgeon creator’s ownership of theidea and the business. It is not unheard of for the surgeon inventor to endup with less than ten percent of the total economic worth of an endeavorlaunched from his creativity.I wish that I could tell my colleagues about a sure-found pathway tosuccess, but since my efforts are still very much a work in progress, I’mnot in a position to proffer any specific advice. I will, however, offer someof my own experiences.Finding a patent attorney who is experienced with medical devices(especially orthopaedic ones) is quite challenging. Those who are experiencedin the art usually have conflicts of interest which limit taking on newprojects, especially if your concept is in an area in which they are workingwith other clients. Patent law is similar to any medical specialization. Goodpatent attorneys have read “the literature” and are aware of case law thatwill dictate the likelihood that the patent will be enforceable. The othercritical issue revolves around infringement. As crazy as it sounds, the U.S.Patent Office will issue you a patent that violates another patent’s claims,so having a patent awarded does not of itself mean that your concept is freeto be practiced. Your idea will need to have both patentability and infringementanalyses. Budgeting for patent costs will vary by the complexity ofthe device and time needed, but would be a minimum of $10,000 and couldexceed $50,000. Patents need to be renewed every four years, which willadd another $3,000 to $4,000 each time. Don’t think that a single patentwill protect your idea, either. Engineers are very resourceful, and very fewpatents successfully control an entire area in orthopaedics. Almost all totalknees have patents specific to their manufacturer, however, there are tensof different brands of total knee devices. Therefore, you should plan on atleast three different patents to try to shield your creation.continued on page 4644 Orthopaedic Product News • January/February 2007
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