Neurosurgery remains a realm of rapid developments and innovations unlike any other specialty. The neurosurgeon who practices in the fields of vascular, functional, oncological and spine neurosurgery is uniquely positioned to be on the vanguard of those developments. As neurosurgeons, we practice our art day-to-day in the operating theater where we identify and overcome the obstacles we encounter in the care of our patients through thoughtful innovation. We develop new techniques, conceive new solutions, modify current instruments or design new instruments or novel implants altogether. In doing so, a natural relationship has the potential to arise between the practicing neurosurgeon and an industry partner to foster and develop those ideas, techniques and designs. A symbiotic relationship between the practicing neurosurgery and an industry partner is one of the vehicles that advances our field. From that mutual interest arises the possibility of consultancy with industry. Understanding the process of protecting your intellectual property along with exhibiting full transparency in industry relationships that develop are the two guiding principles for neurosurgeons exploring a consultancy relationship.
Intellectual property can be a contentious issue, especially for an idea that develops into a widely implemented solution. By the time an idea is fully developed, the proverbial drawing on the back of a napkin at a restaurant simply does not hold any water. When a neurosurgeon conceives of an idea or solution to a current problem, it is a worthwhile investment to have a conversation with a patent attorney and begin to explore the patent process. There are several phases to securing a patent for your idea, beginning with a provisional patent application. No proof of principle needs to be established at the time of the application and no prototype needs to have been manufactured. Rather, the drawing on the back of the napkin needs to be formalized by a draftsman and a description of the device or process needs to be laid out. Once the provisional application is filed, the idea is protected. From there, approaching industry to explore a collaborative development of the concept, design or idea allows a clear demarcation in the origins of the intellectual property. Over the time period of the provisional patent, the inventor can demonstrate a proof of principle and manufacture, develop and refine a prototype. With the progress made, a utilization patent is filed with expanded claims and the patent undergoes review by the United States Patent Office. The entire process may span 2-3 years and there is nothing to guarantee that a patent will be awarded. However, filing a provisional patent remains an essential first step to protect an idea. Approaching industry with an idea protected by a provisional patent clearly defines the origins of the concept and allows all the energy to focus on the development, refinement and delivery of the concept. Protecting intellectual property helps all parties involved.
Not all consultancy relationships revolve around the development of novel intellectual property. Most involve continued refinement of current technology, strategic planning as well as education and training of other surgeons. The central principle to a successful and sustainable consultant relationship is transparency with your colleagues, your publications and your patients. In 2010, Congress passed the Physician Payments Sunshine Act with the objective of increasing the transparency of financial relationships between physicians and industry.1 The law requires manufacturers of drugs, medical devices and medical supplies that are covered by Medicare and Medicaid to collect, track and report all financial relationships with physicians. In 2014, the Centers for Medicare and Medicaid Services made available all of the reported information on its Open Payment Program website.2 The true value of such a database remains uncertain, if not in question, but beyond the scope of this current work. Suffice it to say, a cup of coffee that was purchased for you by an industry representative during a conversation regarding the temperature control at the tip of a bipolar for vascular cases or applications of an ipsilateral expandable rod in a lumbar fusion will appear on that site. It is also important to recognize the fallibility of that reporting system and the ability to refute charges. After all, effective transparency, requires more than a public data dump into a website. But with the data dumps out there, narratives may arise that paint physicians involved in consultancy relationship in a less than flattering color. In 2018, the New York Times published an exposé entitled “Doctors and Disclosures,” where the authors highlighted example after example of physicians who published reports on oncological therapies in peer review literature without disclosing their relationship with the industry sponsor of the medications.3 Avoid these unnecessary distractions and instead take complete control of the narrative yourself by offering patients and your colleagues complete transparency.
Should the opportunity for consultancy with industry arise, it is advisable to have a document prepared that fully discloses that relationship and make it available to your patients as part of the intake process. Full disclosure of all industry relationships at the beginning of all presentations at national meetings and including them in all publications in the peer-reviewed literature creates an environment of transparency.
Relationships between industry and the neurosurgeon is one of the vehicles that drives innovation in our field. Protecting your intellectual property and offering full transparency with all industry relationships allows for a meaningful and sustainable career as a consultant as a neurosurgeon.
References
- Physician Payments Sunshine Act. https://www.congress.gov. Accessed on November 6th, 2020.
- Open Payments Data. https://www.openpaymentsdata.cms.gov. Accessed on November 6, 2020.
- Thomas K, Orstein C. “Doctors and Disclosures” December 8, 2018. https://www.nytimes.com/2018/12/08/health/medical-journals-conflicts-of-interest.htmlhttps://www.nytimes.com. Accessed on November 6, 2020
Disclosures
Luis M. Tumialán, MD, FAANS, is consultant for Medtronic and Zimmer-Biomet. He invested in LessRay, which was acquired by NuVasive. He owns stock in TrackX. He has been awarded five patents by the U.S. Patent Office.
