From the Department of Otolaryngology, Columbia University, and the New York Center for Voice and Swallowing Disorders, Columbia University, New York, NY (Dr Blitzer); Division of Head and Neck Surgery, University of California, Los Angeles (Dr Binder); and Ear, Nose, and Throat Devices Branch, US Food and Drug Administration, Rockville, Md (Dr Jaffee).
Many clinicians have wonderful ideas for new drugs and devices, but they are not certain how to bring them to market. Generally, a clinician should contact an intellectual properties lawyer to help protect an idea. Then the clinician may approach a company with the idea, although it is advisable to have a patent application filed before any conversations with an industrial partner take place. Next, confidentiality agreements are signed by both parties. If the idea is accepted, the Food and Drug Administration (FDA) applications for testing and marketing approval can be filed. If the clinician feels he or she can accomplish the filing and testing independently, he or she can file alone.
Blitzer A, Binder WJ, Jaffee IS. Bringing a New Medical Device to Market. Arch Facial Plast Surg. 2000;2(1):64-65. doi: