title: The Translational Research Working Group developmental pathway for interventive devices.
abstract: The interventive device pathway refers to one of six pathways developed by the Translational Research Working Group (TRWG) that, together, describe the core domains of early translational cancer research. This pathway focuses on the development of devices (as classified by the Food and Drug Administration), designed for local ablation of cancer or precancerous lesions (e.g., radiation therapy, microwave, radiofrequency ablation, and high-intensity focused ultrasound systems). This article describes the distinctive features of the pathway and issues that are encountered in the real-world development of interventive devices for the treatment of cancer. The interventive device pathway is envisioned to be a general guideline of the steps required for effective development, optimization, testing, and validation of developing devices, to be dynamic and adaptable, and to form a framework for discussions focused on improving the efficiency and effectiveness of new device development.
authors.affiliation: Weill Cornell Medical College, New York, New York, USA.
authors.forename: Gary S
authors.initials: GS
authors.lastname: Dorfman
authors.forename: Theodore S
authors.initials: TS
authors.lastname: Lawrence
authors.forename: Lynn M
authors.initials: LM
authors.lastname: Matrisian
mesh_terms: D018795:Device Approval; D003952:Diagnostic Imaging; D006801:Humans; D009316:National Institutes of Health (U.S.); D009369:Neoplasms / Q000517:prevention & control / Q000628:therapy*; D011230:Precancerous Conditions / Q000517:prevention & control / Q000628:therapy; D016730:Program Development; D011878:Radiotherapy; D012371:Robotics; D012985:Software Design; D013672:Technology; D014481:United States; D014486:United States Food and Drug Administration