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Proceedings Papers

Review of Fda Manufacturer and User Facility Device Experience Database Reports on Driveline Fractures in Heartmate 2 LVAD

Free

Ashish Singal, Robert Hauser, Peter Eckman
Proc. ASME. DMD2025, 2025 Design of Medical Devices Conference, V001T01A003, April 28–30, 2025
Publisher: American Society of Mechanical Engineers
Paper No: DMD2025-1027
https://doi.org/10.1115/DMD2025-1027
View Paper titled, Review of Fda Manufacturer and User Facility Device Experience Database Reports on Driveline Fractures in Heartmate 2 LVAD
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Topics: Databases, Failure, Flow (Dynamics), Food and Drug Administration, Fracture (Materials), Fracture (Process), Frequency-domain analysis, Heart failure, Maintenance, Pumps
Proceedings Papers

Burst, Leakage, and Constant Pressure Infusion Testing of a Convection Enhanced Drug Delivery System for Glioblastoma Treatment

Free

Iman Salafian, Christopher G. Rylander
Proc. ASME. DMD2022, 2022 Design of Medical Devices Conference, V001T10A006, April 11–14, 2022
Publisher: American Society of Mechanical Engineers
Paper No: DMD2022-1060
https://doi.org/10.1115/DMD2022-1060
View Paper titled, Burst, Leakage, and Constant Pressure Infusion Testing of a Convection Enhanced Drug Delivery System for Glioblastoma Treatment
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Topics: Catheters, Convection, Drug delivery systems, Fibers, Flow (Dynamics), Food and Drug Administration, Frequency-domain analysis, Leakage, Microneedles, Pressure
Proceedings Papers

Communicating Cybersecurity and Privacy Design Attributes through Privacy Labeling of Consumer Electronic Medical Devices

Free

Monroe J. Molesky
Proc. ASME. DMD2022, 2022 Design of Medical Devices Conference, V001T03A001, April 11–14, 2022
Publisher: American Society of Mechanical Engineers
Paper No: DMD2022-1045
https://doi.org/10.1115/DMD2022-1045
View Paper titled, Communicating Cybersecurity and Privacy Design Attributes through Privacy Labeling of Consumer Electronic Medical Devices
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Topics: Computer security, Design, Food and Drug Administration, Frequency-domain analysis, Medical devices
Proceedings Papers

A Vibrotactile Wearable for the Ear for Vagus Nerve Stimulation

Free

Josh Adams, Colton Doherty, Eric Leuthardt, Jenna Gorlewicz
Proc. ASME. DMD2022, 2022 Design of Medical Devices Conference, V001T04A006, April 11–14, 2022
Publisher: American Society of Mechanical Engineers
Paper No: DMD2022-1047
https://doi.org/10.1115/DMD2022-1047
View Paper titled, A Vibrotactile Wearable for the Ear for Vagus Nerve Stimulation
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Topics: Additive manufacturing, Ear, Patient treatment, Vibration, Batteries, Drugs, Electronics, Engineering prototypes, Feedback, Food and Drug Administration
Proceedings Papers

Cardiovascular Medical Devices: Regulatory Science Research Overview in the Office of Science and Engineering Laboratories (OSEL) at the Food and Drug Administration (FDA)

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Kenneth Aycock, Ksenia Blinova, Maura Casciola, Brent Craven, Matthew Di Prima, Gavin D’Souza, Nandini Duraiswamy, Masoud Farahmand, Prasanna Hariharan, Luke Herbertson, Megan Jamiolkowski, Qijin Lu, Richard Malinauskas, Mehulkumar Patel, Jean Rinaldi, Shiril Sivan, Oleg Vesnovsky, Jason Weaver
Proc. ASME. DMD2021, 2021 Design of Medical Devices Conference, V001T02A011, April 12–15, 2021
Publisher: American Society of Mechanical Engineers
Paper No: DMD2021-1085
https://doi.org/10.1115/DMD2021-1085
View Paper titled, Cardiovascular Medical Devices: Regulatory Science Research Overview in the Office of Science and Engineering Laboratories (OSEL) at the Food and Drug Administration (FDA)
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Topics: Cardiovascular system, Engineering laboratories, Food and Drug Administration, Medical devices
Proceedings Papers

Thrombogenicity Testing Results for Control Legally Marketed Comparator Devices (LMCD): Comparison Between Traditional Non-Anticoagulated Venous Implant (NAVI) Assay and an In Vitro Ovine Blood Loop Test

Free

Mark E. Smith, Yan Chen
Proc. ASME. DMD2020, 2020 Design of Medical Devices Conference, V001T01A011, April 6–9, 2020
Publisher: American Society of Mechanical Engineers
Paper No: DMD2020-9073
https://doi.org/10.1115/DMD2020-9073
View Paper titled, Thrombogenicity Testing Results for Control Legally Marketed Comparator Devices (LMCD): Comparison Between Traditional Non-Anticoagulated Venous Implant (NAVI) Assay and an In Vitro Ovine Blood Loop Test
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Topics: Blood, Medical devices, Testing, Thrombosis, Assaying, Food and Drug Administration, Frequency-domain analysis, Manufacturing industry
Proceedings Papers

Advancing Directional Deep Brain Stimulation Array Technology

Free

Julia P. Slopsema, Robert Cass, Mark Hjelle, Matthew D. Johnson
Proc. ASME. DMD2019, 2019 Design of Medical Devices Conference, V001T02A004, April 15–18, 2019
Publisher: American Society of Mechanical Engineers
Paper No: DMD2019-3312
https://doi.org/10.1115/DMD2019-3312
View Paper titled, Advancing Directional Deep Brain Stimulation Array Technology
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Topics: Brain, Electrodes, Computer simulation, Electrochemical impedance spectroscopy, Food and Drug Administration, Frequency-domain analysis, Patient treatment
Proceedings Papers

Combination Product Patient Training: How Are Patients Trained and Who Conducts the Training?

Free

Virginia A. Lang, David Nalan
Proc. ASME. DMD2018, 2018 Design of Medical Devices Conference, V001T09A003, April 9–12, 2018
Publisher: American Society of Mechanical Engineers
Paper No: DMD2018-6956
https://doi.org/10.1115/DMD2018-6956
View Paper titled, Combination Product Patient Training: How Are Patients Trained and Who Conducts the Training?
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Topics: Drugs, Errors, Food and Drug Administration, Human factors, Medical devices, Regulations, Sprays, Testing
Proceedings Papers

A Framework of Simulating Virtual Spine Patients to Assess Thoracic Volume Variations due to Wedging Deformities

Free

Po-Chih Lee, Arthur G. Erdman, Charles Ledonio, David Polly
Proc. ASME. DMD2018, 2018 Design of Medical Devices Conference, V001T03A009, April 9–12, 2018
Publisher: American Society of Mechanical Engineers
Paper No: DMD2018-6853
https://doi.org/10.1115/DMD2018-6853
View Paper titled, A Framework of Simulating Virtual Spine Patients to Assess Thoracic Volume Variations due to Wedging Deformities
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Topics: Biomedicine, Computer software, Computer-aided design, Computers, Education, Fluid dynamics, Food and Drug Administration, Health care, Patient diagnosis, Simulation
Proceedings Papers

Vagus Nerve Stimulation for Blood Pressure and Heart Rate Regulation

Free

George D. O’Clock, Bruce H. KenKnight, Elena G. Tolkacheva
Proc. ASME. DMD2018, 2018 Design of Medical Devices Conference, V001T01A004, April 9–12, 2018
Publisher: American Society of Mechanical Engineers
Paper No: DMD2018-6847
https://doi.org/10.1115/DMD2018-6847
View Paper titled, Vagus Nerve Stimulation for Blood Pressure and Heart Rate Regulation
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Topics: Blood, Pressure, Compression, Surgery, Belts, Clearances (Engineering), Diseases, Electric current, Food and Drug Administration, Frequency-domain analysis
Proceedings Papers

Programmable Ultrasound Phased Array Therapy System

Free

Yiying I. Zhu, Timothy L. Hall, Oliver D. Kripfgans
Proc. ASME. DMD2017, 2017 Design of Medical Devices Conference, V001T08A008, April 10–13, 2017
Publisher: American Society of Mechanical Engineers
Paper No: DMD2017-3370
https://doi.org/10.1115/DMD2017-3370
View Paper titled, Programmable Ultrasound Phased Array Therapy System
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Topics: Patient treatment, Ultrasound, Cycles, Design, Ablation (Vaporization technology), Acoustics, Biological tissues, Transients (Dynamics), Bone, Circuits
Proceedings Papers

Modification of the ASTM Platelet and Leukocyte Assay: Use of an Alternative and Clinically Relevant Anticoagulant — An In-Vitro Hemocompatibility Assessment of Blood Contacting Medical Devices

Free

Tim Schatz, Abby Beltrame, Sarah Howard, Mark Smith
Proc. ASME. DMD2017, 2017 Design of Medical Devices Conference, V001T01A003, April 10–13, 2017
Publisher: American Society of Mechanical Engineers
Paper No: DMD2017-3345
https://doi.org/10.1115/DMD2017-3345
View Paper titled, Modification of the ASTM Platelet and Leukocyte Assay: Use of an Alternative and Clinically Relevant Anticoagulant — An In-Vitro Hemocompatibility Assessment of Blood Contacting Medical Devices
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Topics: ASTM International, Blood, Leukocytes, Medical devices, Platelets, Cardiovascular system, Sodium, Biomaterials, Blanks, Food and Drug Administration
Proceedings Papers

Thrombogenicity Testing for Blood-Contacting Medical Devices in an In Vitro Ovine Blood Loop: Design Improvements and Continuing Validation

Free

Matthew Cunningham, Steve Deline, Tim Schatz, Abby Beltrame, Erik Steinmetz, Sarah Howard, Mark Smith
Proc. ASME. DMD2017, 2017 Design of Medical Devices Conference, V001T01A004, April 10–13, 2017
Publisher: American Society of Mechanical Engineers
Paper No: DMD2017-3385
https://doi.org/10.1115/DMD2017-3385
View Paper titled, Thrombogenicity Testing for Blood-Contacting Medical Devices in an In Vitro Ovine Blood Loop: Design Improvements and Continuing Validation
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Topics: Blood, Design, Medical devices, Testing, Food and Drug Administration, Frequency-domain analysis, Assaying, Catheters, Geometry, Temperature control
Proceedings Papers

Evaluation of Aerosol Leakage Sites Through Respirators Using Image-Based Modeling

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Gavin A. D’Souza, Suvajyoti Guha, Matthew R. Myers, Prasanna Hariharan
Proc. ASME. DMD2017, 2017 Design of Medical Devices Conference, V001T09A007, April 10–13, 2017
Publisher: American Society of Mechanical Engineers
Paper No: DMD2017-3446
https://doi.org/10.1115/DMD2017-3446
View Paper titled, Evaluation of Aerosol Leakage Sites Through Respirators Using Image-Based Modeling
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Topics: Aerosols, Leakage, Modeling, Respirators, Emergencies, Food and Drug Administration, Risk assessment, Surgery, Computational fluid dynamics, Computer-aided design
Proceedings Papers

Pop-Up-Inspired Design of a Septal Anchor for a Ventricular Assist Device

Free

F. Zeynep Temel, Hayley McClintock, Christopher J. Payne, Isaac Wamala, Conor J. Walsh, Nikolay V. Vasilyev, Robert J. Wood
Proc. ASME. DMD2017, 2017 Design of Medical Devices Conference, V001T07A002, April 10–13, 2017
Publisher: American Society of Mechanical Engineers
Paper No: DMD2017-3458
https://doi.org/10.1115/DMD2017-3458
View Paper titled, Pop-Up-Inspired Design of a Septal Anchor for a Ventricular Assist Device
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Topics: Design, Ventricular assist devices, Blood, Heart failure, Manufacturing, Microelectromechanical systems, Patient treatment, Risk, Actuators, Bearings
Proceedings Papers

Uncertainty Estimations for Particle Image Velocimetry in a Medical Device Analog (Nozzle) Model

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Jaime S. Raben, Prasanna Hariharan, Ronald Robinson, Richard Malinauskas, Pavlos P. Vlachos
Proc. ASME. FMD2013, ASME 2013 Conference on Frontiers in Medical Devices: Applications of Computer Modeling and Simulation, V001T01A003, September 11–13, 2013
Publisher: American Society of Mechanical Engineers
Paper No: FMD2013-16164
https://doi.org/10.1115/FMD2013-16164
View Paper titled, Uncertainty Estimations for Particle Image Velocimetry in a Medical Device Analog (Nozzle) Model
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Topics: Medical devices, Nozzles, Particulate matter, Uncertainty, Computational fluid dynamics, Flow (Dynamics), Food and Drug Administration, Frequency-domain analysis, Magnification, Velocity measurement
Proceedings Papers

Use of QSAR Modeling to Predict the Carcinogenicity of Color Additives

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Ronald Brown, Shannon White, Jennifer Goode, Prachi Pradeep, Stephen Merrill
Proc. ASME. FMD2013, ASME 2013 Conference on Frontiers in Medical Devices: Applications of Computer Modeling and Simulation, V001T10A044, September 11–13, 2013
Publisher: American Society of Mechanical Engineers
Paper No: FMD2013-16161
https://doi.org/10.1115/FMD2013-16161
View Paper titled, Use of QSAR Modeling to Predict the Carcinogenicity of Color Additives
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Topics: Modeling, Medical devices, Safety, Testing, Food and Drug Administration, Computer simulation, Polymers
Proceedings Papers

EmboLess Mechanical Clot Removal Device: Possibility for Improving the Outcomes of Ischemic Stroke Patients

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Joseph Perosky, Adam Biddle, Kim DeGraaf, Whitney Hovan, Choi M. Li, Shishira Nagesh
Proc. ASME. BIOMED2010, ASME 2010 5th Frontiers in Biomedical Devices Conference and Exhibition, 39-40, September 20–21, 2010
Publisher: American Society of Mechanical Engineers
Paper No: BioMed2010-32072
https://doi.org/10.1115/BioMed2010-32072
View Paper titled, EmboLess Mechanical Clot Removal Device: Possibility for Improving the Outcomes of Ischemic Stroke Patients
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Topics: Biological tissues, Blood, Brain, Cutting, Food and Drug Administration, Frequency-domain analysis, Performance, Vessels
Proceedings Papers

Lumbar Disc Replacement Failures: Review of 29 Patients and Rationale for Revision

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Charles Rosen, Douglas P. Kiester, Thay Q. Lee
Proc. ASME. BIOMED2009, ASME 2009 4th Frontiers in Biomedical Devices, 95-96, June 8–9, 2009
Publisher: American Society of Mechanical Engineers
Paper No: BioMed2009-83060
https://doi.org/10.1115/BioMed2009-83060
View Paper titled, Lumbar Disc Replacement Failures: Review of 29 Patients and Rationale for Revision
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Topics: Disks, Failure, Food and Drug Administration, Frequency-domain analysis, Surgery