title: Developing, regulating, and ethically evaluating new technologies in otolaryngology-head and neck surgery.
abstract: New technologies continue to affect the practice of otolaryngology-head and neck surgery. Numerous financial and regulatory barriers must be overcome to develop an idea into a useful device or intervention. US Food and Drug Administration (FDA) approval focuses on safety, often leaving the medical community, in general, to determine the efficacy of the device after FDA approval has been granted. Physicians are involved throughout the technology development process, generating conflicts of interest that must be effectively managed. It is essential that physicians ethically maintain their leadership in developing and evaluating new advances in medical technology.
authors.affiliation: Division of Otolaryngology-Head and Neck Surgery, University of Utah, 50 North Medical Drive, 3C120, Salt Lake City, UT 84132, USA. richard.orlandi@hsc.utah.edu
authors.forename: Richard R
authors.initials: RR
authors.lastname: Orlandi
authors.forename: Bradley F
authors.initials: BF
authors.lastname: Marple
mesh_terms: D039702:Current Procedural Terminology; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D004724:Endoscopy; D006801:Humans; D013517:Otorhinolaryngologic Surgical Procedures / Q000941:ethics / Q000295:instrumentation / Q000379:methods / Q000639:trends; D011358:Product Surveillance, Postmarketing; D014481:United States