Developing, Regulating, and Ethically Evaluating New Technologies in Otolaryngology-Head and Neck Surgery

Richard R. Orlandi, Bradley F. Marple

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)739-745
Number of pages7
JournalOtolaryngologic Clinics of North America
Volume42
Issue number5
DOIs
StatePublished - Oct 2009

Fingerprint

Otolaryngology
Device Approval
Neck
Head
Technology
Physicians
Drug Approval
Conflict of Interest
Safety
Food
Equipment and Supplies
Industrial Development

Keywords

  • Conflict of interest
  • Device
  • Disclosure
  • Regulatory approval
  • Technology

ASJC Scopus subject areas

  • Otorhinolaryngology

Cite this

Developing, Regulating, and Ethically Evaluating New Technologies in Otolaryngology-Head and Neck Surgery. / Orlandi, Richard R.; Marple, Bradley F.

In: Otolaryngologic Clinics of North America, Vol. 42, No. 5, 10.2009, p. 739-745.

Research output: Contribution to journalArticle

@article{ea3e87c29b0f45629fc609454ac63f11,
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.",
keywords = "Conflict of interest, Device, Disclosure, Regulatory approval, Technology",
author = "Orlandi, {Richard R.} and Marple, {Bradley F.}",
year = "2009",
month = "10",
doi = "10.1016/j.otc.2009.07.007",
language = "English (US)",
volume = "42",
pages = "739--745",
journal = "Otolaryngologic Clinics of North America",
issn = "0030-6665",
publisher = "W.B. Saunders Ltd",
number = "5",

}

TY - JOUR

T1 - Developing, Regulating, and Ethically Evaluating New Technologies in Otolaryngology-Head and Neck Surgery

AU - Orlandi, Richard R.

AU - Marple, Bradley F.

PY - 2009/10

Y1 - 2009/10

N2 - 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.

AB - 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.

KW - Conflict of interest

KW - Device

KW - Disclosure

KW - Regulatory approval

KW - Technology

UR - http://www.scopus.com/inward/record.url?scp=70350754632&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=70350754632&partnerID=8YFLogxK

U2 - 10.1016/j.otc.2009.07.007

DO - 10.1016/j.otc.2009.07.007

M3 - Article

VL - 42

SP - 739

EP - 745

JO - Otolaryngologic Clinics of North America

JF - Otolaryngologic Clinics of North America

SN - 0030-6665

IS - 5

ER -