Guiding Your Medical Device to Market with Regulatory and Technical Expertise
Publications
Peer-Reviewed
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B. Parvinian, R. Bighamian, C. G. Scully, J. O. Hahn, and P. Pathmanathan, “Credibility Assessment of a Subject-Specific Mathematical Model of Blood Volume Kinetics for Prediction of Physiological Response to Hemorrhagic Shock and Fluid Resuscitation,” Front. Physiol., vol. 12, no. September, pp. 1–14, 2021.
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B. Parvinian Pathmanathan P, Daluwatte C, Yaghouby F, Gray RA, Weininger S, Morrison TM, Scully CG., “Credibility evidence for computational patient models used in the development of physiological closed-loop controlled devices for critical care medicine,” Front. Physiol., 2019.
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B. Parvinian, C. Scully, H. Wiyor, A. Kumar, and S. Weininger, “Regulatory Considerations for Physiological Closed-Loop Controlled Medical Devices Used for Automated Critical Care: Food and Drug Administration Workshop Discussion Topics,” Anesth Analg, 2017.
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R. Bighamian, B. Parvinian, C. G. Scully, G. Kramer, and J.-O. Hahn, “Control-oriented physiological modeling of hemodynamic responses to blood volume perturbation,” Control Eng. Pract., vol. 73, no. April 2018, pp. 149–160, Apr. 2018.
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H. Mirinejad, B. Parvinian, J.O. Hahn, C.G. Scully ., “Evaluation of Fluid Resuscitation Control Algorithms via a Hardware-in-the-Loop Test Bed,” IEEE Trans. Biomed. Eng., vol. PP, no. c, p. 1, 2019.
Conference Papers
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Bahram Parvinian , Christopher G. Scully , George C.Kramer, Jin-Oh Hahn, Prasanna Pathmanathan“Investigation of identifiability properties of a fluid resuscitation model for hemorrhagic shock” ASME Verification & Validation Symp (2019) Las Vegas NV
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B. Parvinian Farid Yaghouby, Sandy Weininger, Christopher G. Scully “State of validation evidence for computational models used for design and evaluation of physiological closed-loop mechanical ventilation devices”, Society for Technology in Anesthesia, Miami 2018
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Scully, Christopher & Pathmanathan, Pras & Daluwatte, Chathuri & Yaghouby, Farid & Gray, Richard & Weininger, Sandy & Morrison, Tina, Parvinian, Bahram. (2018). “Applying a Computational Model Credibility Framework to Physiological Closed-Loop Controlled Medical Device Testing”. IEEE Life Sciences Conference. Life Sciences Conference. 2018. 130-133. 10.1109/LSC.2018.8572270.
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Mirinejad, Hossein , Ricks, Margo , Parvinian, Bahram , Hahn, Jin-Oh, Scully, Christopher. (2018). “A Real-Time Hardware-In-The-Loop Testing Platform for Closed-Loop Fluid Resuscitation” 417-418. 10.1109/ICHI.2018.00080.
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B. Parvinian Ramin Bighamian, Pras Pathmanathan , Richard Gray, Sandy Weininger, Farid Yahouby, Chathuri Daluwatte, George Kramer , Tina Morrison,Jin-Oh Hahn Christopher G. Scully “Validation Evidence and Regulatory Context of Use: The Need for a Validation Framework for Applications in Evaluation of Automated Fluid Resuscitation Systems Technical Presentation.” ASME Verification & Validation Symp 2017
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B. Parvinian, R. Bighamian , P. Pathmanathan, T. Morrison, G.C. Kramer, C.G. Scully , J.O. Hahn , “Towards Validation of a Physiological Model Intended for Design and Evaluation of Automated Fluid Resuscitation Systems” BMES-FDA Frontiers in Medical Devices Conference, Washington, DS, USA, May 16-18, (2017).
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R. Bighamian, B. Parvinian, C.G. Scully, G.C. Kramer, J.O. Hahn, “Systems-Level Modeling of Hemodynamic Responses to Hemorrhage and Fluid Infusion,” Northeast Bioengineering Conference, Newark, NJ, USA, March 31-April 2, (2017).
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Bahram Parvinian, Pras Pathmanathan, Tina Morrison, Christopher Scully State of validation of physiological models used for design and evaluation of automated critical care systems FDA Science Forum, White Oak Maryland (2017)
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Bahram Parvinian, Christopher Scully “Regulatory science for non-clinical testing of physiological closed-loop controlled medical devices” Society of Engineering Science 53rd Annual Technical Meeting College Park Maryland (2016).
Invited Panel participation and Presentations
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Invited panel member-South East Medical Device Conference/Global Center for Medical Innovation-2019
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Invited speaker-Society for Technology in Anesthesia-2019
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Invited speaker-BMES conference for medical devices-2017
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Invited speaker-Society for Technology In Anesthesia -2016
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NIH Scientific Forum-2015
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Invited speaker-Smart Monitoring Conference-2014 & 2015
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Invited speaker-Engineering and Science Symposium-2016
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Invited Speaker International Engineering Conference, Montreal-2014
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Invited panel member FDA Critical Care Ventilator Summit, Washington DC 2014
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Society for Technology In Anesthesia , 2016 Presentation Title: Regulatory Consideration for Physiological Closed Loop Controlled Devices
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NIH Scientific Forum August, 2015-Briefing on Upcoming FDA Workshop Focusing on Regulatory Challenges Facing Automated Critical Care Devices
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FDA Scientific Computing day September, 2016- Presentation title: A Framework for evaluation of mathematical models intended for safety evaluation of automated critical care devices
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FDA/AAMI Ventilator Summit September, 2014-Presentation Title: Future of Closed-Loop Mechanical Ventilation