Literature DB >> 30178351

Guidance to Transfer 'Bench-Ready' Medical Technology into Usual Clinical Practice: Case Study - Sensors and Spectrometer Used in EPR Oximetry.

Ann Barry Flood1, Victoria A Wood2, Wilson Schreiber2, Benjamin B Williams3, Bernard Gallez4, Harold M Swartz2,3.   

Abstract

This paper considers the critical role that academics can have in the development of clinical innovations and especially how their impact can be optimized. The focus should be on establishing the safety and efficacy of new approaches while also incorporating human factors and human use considerations into the inventions. It is very advantageous to work in concert with the end-users (operators and clinicians) to help ensure that the innovation will be useful and feasible to be incorporated into actual clinical practice as intended. This strategy enables developments to tackle real clinical needs by providing novel strategies to improve patient care while using solutions that fit into clinical practice and that are welcomed by patients and clinical staff. These principles are illustrated by a case study of the development of clinical in vivo EPR oximetry.

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Year:  2018        PMID: 30178351      PMCID: PMC6126358          DOI: 10.1007/978-3-319-91287-5_37

Source DB:  PubMed          Journal:  Adv Exp Med Biol        ISSN: 0065-2598            Impact factor:   2.622


  14 in total

Review 1.  The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?

Authors:  Kyle M Fargen; Donald Frei; David Fiorella; Cameron G McDougall; Philip M Myers; Joshua A Hirsch; J Mocco
Journal:  J Neurointerv Surg       Date:  2012-07-04       Impact factor: 5.836

2.  Practice-based research--"Blue Highways" on the NIH roadmap.

Authors:  John M Westfall; James Mold; Lyle Fagnan
Journal:  JAMA       Date:  2007-01-24       Impact factor: 56.272

3.  Cardiovascular clinical trials with noninferiority or equivalence designs from 2001 to 2012.

Authors:  Muthiah Vaduganathan; Ravi B Patel; Ayman Samman-Tahhan; Andreas P Kalogeropoulos; Vasiliki V Georgiopoulou; Gregg C Fonarow; Mihai Gheorghiade; Javed Butler
Journal:  Int J Cardiol       Date:  2016-03-26       Impact factor: 4.164

Review 4.  Advances in in vivo EPR Tooth BIOdosimetry: Meeting the targets for initial triage following a large-scale radiation event.

Authors:  Ann Barry Flood; Benjamin B Williams; Wilson Schreiber; Gaixin Du; Victoria A Wood; Maciej M Kmiec; Sergey V Petryakov; Eugene Demidenko; Harold M Swartz
Journal:  Radiat Prot Dosimetry       Date:  2016-07-15       Impact factor: 0.972

5.  FLEXIBLE, WIRELESS, INDUCTIVELY COUPLED SURFACE COIL RESONATOR FOR EPR TOOTH DOSIMETRY.

Authors:  Wilson Schreiber; Sergey V Petryakov; Maciej M Kmiec; Matthew A Feldman; Paul M Meaney; Victoria A Wood; Holly K Boyle; Ann Barry Flood; Benjamin B Williams; Harold M Swartz
Journal:  Radiat Prot Dosimetry       Date:  2016-07-15       Impact factor: 0.972

6.  Innovation in the pharmaceutical industry: New estimates of R&D costs.

Authors:  Joseph A DiMasi; Henry G Grabowski; Ronald W Hansen
Journal:  J Health Econ       Date:  2016-02-12       Impact factor: 3.883

7.  Application of Materials as Medical Devices with Localized Drug Delivery Capabilities for Enhanced Wound Repair.

Authors:  Esther J Lee; Beom Kang Huh; Se Na Kim; Jae Yeon Lee; Chun Gwon Park; Antonios G Mikos; Young Bin Choy
Journal:  Prog Mater Sci       Date:  2017-06-13

8.  Central challenges facing the national clinical research enterprise.

Authors:  Nancy S Sung; William F Crowley; Myron Genel; Patricia Salber; Lewis Sandy; Louis M Sherwood; Stephen B Johnson; Veronica Catanese; Hugh Tilson; Kenneth Getz; Elaine L Larson; David Scheinberg; E Albert Reece; Harold Slavkin; Adrian Dobs; Jack Grebb; Rick A Martinez; Allan Korn; David Rimoin
Journal:  JAMA       Date:  2003-03-12       Impact factor: 56.272

9.  Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs.

Authors:  Gail A Van Norman
Journal:  JACC Basic Transl Sci       Date:  2016-04-25

10.  Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices.

Authors:  Gail A Van Norman
Journal:  JACC Basic Transl Sci       Date:  2016-06-27
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  3 in total

1.  Electron paramagnetic resonance oximetry as a novel approach to monitor the effectiveness and quality of red blood cell transfusions.

Authors:  Huagang Hou; Jin H Baek; Hao Zhang; Francine Wood; Yamei Gao; Ann B Flood; Harold M Swartz; Paul W Buehler
Journal:  Blood Transfus       Date:  2019-05-16       Impact factor: 3.443

Review 2.  Preclinical Applications of Multi-Platform Imaging in Animal Models of Cancer.

Authors:  Natalie J Serkova; Kristine Glunde; Chad R Haney; Mohammed Farhoud; Alexandra De Lille; Elizabeth F Redente; Dmitri Simberg; David C Westerly; Lynn Griffin; Ralph P Mason
Journal:  Cancer Res       Date:  2020-12-01       Impact factor: 13.312

Review 3.  The Role of Imaging Biomarkers to Guide Pharmacological Interventions Targeting Tumor Hypoxia.

Authors:  Bernard Gallez
Journal:  Front Pharmacol       Date:  2022-07-15       Impact factor: 5.988

  3 in total

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