For radiology to move forward, it’s vital for radiologists to navigate the complex process to bring new innovations to market. Here’s how.
Medical knowledge is growing at an unprecedented rate, and as the population ages, so too is the complexity of patient cases. With an ever-evolving knowledge of disease processes and technology, medical professionals are now in a unique position to create innovative solutions to problems that may have not been developed just years prior.
Radiologists, in particular, are situated in an exciting position as a specialty that is in and of itself innovative; coupled with their procedural breadth and role in inter-disciplinary care, the possibilities for innovation within the field are near limitless.
The benefits of innovating in medicine in general-and radiology in particular-are countless, ranging from directly altering patient care for the better, increasing institutional or practice notoriety and funding, and even positively changing one’s career trajectory.
Despite these advantages, however, innovation is far from easy. A successful product will require the physician- entrepreneur to gain knowledge of the process of product development, take advantage of available local or institutional resources, and successfully navigate applicable patent and FDA regulations.
Managing steps and funding
The process is far from streamlined, and fundamental knowledge of the steps in the development process can prove invaluable:
Balancing full-time radiologist responsibilities along with these R&D requirements (including financing the entire process) can alone prove near impossible; which is why the majority of physician entrepreneurs seek assistance. The route a radiologist pursues is typically dependent on their employment setting.
Related article: Radiologist’s Guide to Entrepreneurship
For the radiologist in private practice, there are two major courses:
For the radiologist in an academic setting, the process only differs in the presence of a “middle-man,” known as the Technology Transfer Office (TTO) or Technology Commercialization Office (TCO). During the early discussions with the TTO, the inventor should examine any stipulations involving intellectual property in his or her employment contract and may seek legal expertise prior to starting institutional negotiations to fully understand the commercialization options and legal rights as well as obligations.
After receiving the inventor’s proposal, the TTO will study the idea or product and decide whether they will pursue the opportunity. If the TTO appreciates the invention’s potential, they will assemble a team that will take the product from initial R&D to marketing-but for a price, usually leaving the inventor with partial ownership of the product or royalties. The TTO is particularly helpful for aiding a new physician entrepreneur in the complex process of licensing the product to larger corporations or creating a start-up company.
Each path offers unique advantages and disadvantages, which should be considered by the radiologist and their team before moving forward, but this is all dependent on their idea remaining protected.
Two of the most complex and more important elements in successful product development are obtaining a patent and navigating applicable FDA and other regulations.
Patents and the stipulations surrounding them can be confusing to the extent that there is an entire sub-specialty of law devoted to intellectual property. A patent simply offers a limited monopoly on an idea or product, given that the product is new, useful, and non-obvious. The basics of a patent application are an invention description, claims of what it performs, and design drawings with specifications. Patents and associated attorney fees generally range anywhere from $1,500 to $15,000 (depending on the complexity of the invention), with most medical devices falling on the higher end of the spectrum.
A cheaper, temporizing option is a provisional patent, which consists of only drawings and brief descriptions demonstrating functional use. It lasts a year and gives a new inventor time to further develop the product and build a business around the idea with a complete patent being the ultimate goal.
For medical devices, even after proving that an idea is truly novel and obtaining a patent, the next hurdle to cross is showing that it is both safe and effective to the FDA and seeking their approval. The high cost of navigating federal regulations makes a large corporate or institutional sponsor nearly essential at this point of the process.
Why go through the process?
While the process of developing an idea into a patented device and molding that into a successful company can be daunting, not only is it possible, it is necessary. Medicine will continue to evolve, and along with it, the need for innovative technologies to solve emerging problems.
A radiologist’s ability to innovate is a function of his or her foundational knowledge of the product development process and the successful utility of available resources in their practice environment.
Mastering this skill set is essential to fostering an innovative sprit in radiology and contributing to a paradigm shift in medicine that will help revolutionize the standard of care to less invasive and more cost-effective options for our patients.