After the optimal problem has been identified, the inventor needs to develop novel solutions and have a willingness to fail. American otolaryngologists are individuals who have experienced tremendous success in their careers and are often reluctant to risk their reputations and prestige by championing ideas that are unsuccessful. However, all innovation will pass through an initial development cycle where almost no one but the inventor believes in its success and has the passion to develop and disrupt an established market/system. Having the courage to fail and the willingness to refine but passionately believe in your ideas is a requirement for successful invention.
Next, otolaryngologists need to educate themselves early on the FDA requirements for receiving approval to market Class I, Class II, and Class III devices and drugs. These regulatory requirements are easily accessed at the FDA websites. Ideally, these should be understood before an inventor embarks on the design and creation of a novel medical solution unless the solution involves non-medical aspects of patient care (physician workflow, improved documentation methods, and so on). Arcane requirements in diverse fields such as biocompatibility, sterilizability, and electrical safety, and potential development costs such as clinical trial requirements, will help drive initial refinements to the design of a solution.
At this point, inventors are ready to document and lay ownership to their intellectual property. This is done typically by creating annotated handwritten drawings of a solution and providing explanations of why this solution is an improvement over any predicate devices or how no solution for the problem exists. Inventors should date and sign their drawings, typically in a lab notebook, and ideally have another trusted party witness and co-sign the initial creation of their medical intellectual property.
Developing a Business
Private physicians should form their own small business via an LLC or, ideally, a C-corporation, which is the preferred instrument for raising future capital, as well as file a provisional patent with the USPTO. This is a convenient way to extend intellectual property protection for 12 months with a nominal cost. Physicians may consult with a patent attorney (often quite expensive) if necessary. Academicians should file an invention disclosure with their licensing office and directly contact their institutional licensing leadership to discuss their invention. The licensing office, at the bequest of a demanding and non-passive inventor, will often file a provisional patent on behalf of the inventor, particularly before any poster or oral presentations are given about the invention. The academician will need to continue to be aggressive with their licensing office, lead in the development process, and not expect to be able to hand off any inventions to the control and development of their licensing office.