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Journal Articles

A Comparative Evaluation of New and Used Dental Explorer Working Tips

Accepted Manuscript
Arthur Valeri, Charlie Cage, Terrence Donovan
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices.
Paper No: MED-24-1081
https://doi.org/10.1115/1.4066699
Published Online: September 28, 2024
View Article titled, A Comparative Evaluation of New and Used Dental Explorer Working Tips
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Topics: Dimensions, Engineering standards, Instrumentation, Medical devices, Optical microscopy, Performance
Journal Articles

Regulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework

Sanju Kaladharan, Dhanya Manayath, Rejikumar Gopalakrishnan
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Review Articles
J. Med. Devices. December 2024, 18(4): 040801.
Paper No: MED-24-1065
https://doi.org/10.1115/1.4066280
Published Online: September 19, 2024
View Article titled, Regulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework
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Topics: Artificial intelligence, Computer security, Health care, Machine learning, Medical devices, Sustainability, Economics , Regulations, Safety, Health systems
Includes: Supplementary data
Journal Articles

A Modular Nitinol Model With Lode Angle-Based Asymmetry and Improved Representation of the Superelastic Loops for Medical Device Applications

John Mould, Alex Kelly, Ash Peterson, Nuno Rebelo
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. June 2024, 18(2): 024501.
Paper No: MED-23-1125
https://doi.org/10.1115/1.4065513
Published Online: May 30, 2024
View Article titled, A Modular Nitinol Model With Lode Angle-Based Asymmetry and Improved Representation of the Superelastic Loops for Medical Device Applications
Open the PDF for A Modular Nitinol Model With Lode Angle-Based Asymmetry and Improved Representation of the Superelastic Loops for Medical Device Applications in another window
Topics: Compression, Medical devices, Tension, Nickel titanium alloys, Shear (Mechanics), Stress
Journal Articles

Gravity Augmented Fused Filament Fabrication Additive Manufacturing

John M. Huss, Arthur G. Erdman
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. June 2023, 17(2): 021003.
Paper No: MED-22-1080
https://doi.org/10.1115/1.4056909
Published Online: April 17, 2023
View Article titled, Gravity Augmented Fused Filament Fabrication Additive Manufacturing
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Topics: Additive manufacturing, Design, Gravity (Force), Manufacturing, Medical devices, Nozzles, Printing, Toolpaths, Algorithms
Journal Articles

Stakeholders, Prototypes, and Settings of Front-End Medical Device Design Activities

Marianna J. Coulentianos, Ilka Rodriguez-Calero, Shanna R. Daly, Jocelyn Burridge, Kathleen H. Sienko
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. September 2022, 16(3): 031010.
Paper No: MED-21-1147
https://doi.org/10.1115/1.4054207
Published Online: May 18, 2022
View Article titled, Stakeholders, Prototypes, and Settings of Front-End Medical Device Design Activities
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Topics: Design, Engineering prototypes, Medical devices
Journal Articles

“Study on Device System to Reduce Tracheal Mucosal Injury in Intubation Patients” [ASME Journal of Medical Devices, 2022, 16 (3), p. 031006; DOI: 10.1115/1.4054334 ]

Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. September 2022, 16(3): 031006.
Paper No: MED-21-1124
https://doi.org/10.1115/1.4054334
Published Online: May 10, 2022
View Article titled, “Study on Device System to Reduce Tracheal Mucosal Injury in Intubation Patients” [ASME Journal of Medical Devices, 2022, 16 (3), p. 031006; DOI: 10.1115/1.4054334 ]
Open the PDF for “Study on Device System to Reduce Tracheal Mucosal Injury in Intubation Patients” [ASME Journal of Medical Devices, 2022, 16 (3), p. 031006; DOI: 10.1115/1.4054334 ] in another window
Topics: Medical devices, Trachea, Wounds
Journal Articles

Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An ISPOR Medical Devices and Diagnostics Special Interest Group Report

Nneka C. Onwudiwe, Richard Charter, Bruce Gingles, Payam Abrishami, Henry Alder, Ameet Bahkai, Diane Civic, Melodi Kosaner Kließ, Chantale Lessard, Carla L. Zema
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. September 2022, 16(3): 034701.
Paper No: MED-20-1229
https://doi.org/10.1115/1.4053928
Published Online: April 12, 2022
View Article titled, Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An ISPOR Medical Devices and Diagnostics Special Interest Group Report
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Topics: Medical devices, Safety, Performance, Design
Journal Articles

Use of Real-World Data for Enhancing Model Credibility: Applications to Medical Device Development

Paul Briant, Jeffrey E. Bischoff, Mehul A. Dharia, Franck Le Navéaux, XueMei Li, Sanjeev Kulkarni, Danny Levine, David O. Ramos, Payman Afshari
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. September 2022, 16(3): 031001.
Paper No: MED-21-1176
https://doi.org/10.1115/1.4053888
Published Online: March 22, 2022
View Article titled, Use of Real-World Data for Enhancing Model Credibility: Applications to Medical Device Development
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Topics: Calibration, Computer simulation, Failure mechanisms, Fracture (Materials), Fracture (Process), Medical devices, Stress, Testing
Journal Articles

iQbD: A Technological Readiness Level-Indexed Quality-by-Design Paradigm for Medical Device Engineering

Thierry Bastogne
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. June 2022, 16(2): 021008.
Paper No: MED-20-1208
https://doi.org/10.1115/1.4053721
Published Online: March 2, 2022
View Article titled, iQbD: A Technological Readiness Level-Indexed Quality-by-Design Paradigm for Medical Device Engineering
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Topics: Design, Medical devices, Cycles, Control equipment
Journal Articles

Special Issue: Medical Devices for Economically Disadvantaged People and Populations: Perspective Problems and Prospective Solutions

R. Lyle Hood, Boris Rubinsky
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Guest Editorial
J. Med. Devices. March 2020, 14(1): 010301.
Paper No: MED-20-1001
https://doi.org/10.1115/1.4046008
Published Online: February 5, 2020
View Article titled, Special Issue: Medical Devices for Economically Disadvantaged People and Populations: Perspective Problems and Prospective Solutions
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Topics: Medical devices, Health care
Journal Articles

Medical Devices for Low- and Middle-Income Countries: A Review and Directions for Development

Aditya Vasan, James Friend
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Review Articles
J. Med. Devices. March 2020, 14(1): 010803.
Paper No: MED-19-1136
https://doi.org/10.1115/1.4045910
Published Online: February 5, 2020
View Article titled, Medical Devices for Low- and Middle-Income Countries: A Review and Directions for Development
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Topics: Diseases, Health care, Heavy metals, Medical devices, Water, Surgery
Journal Articles

Assessing the Usability of a Task-Shifting Device for Inserting Subcutaneous Contraceptive Implants for Use in Low-Income Countries

Kevin C. Jiang, Ibrahim Mohedas, Gashaw Andargie Biks, Mulat Adefris, Takele Tadesse Adafrie, Delayehu Bekele, Zerihun Abebe, Ajay Kolli, Annabel Weiner, José Davila, Biruk Mengstu, Carrie Bell, Kathleen H. Sienko
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. March 2020, 14(1): 011108.
Paper No: MED-19-1135
https://doi.org/10.1115/1.4046092
Published Online: February 5, 2020
View Article titled, Assessing the Usability of a Task-Shifting Device for Inserting Subcutaneous Contraceptive Implants for Use in Low-Income Countries
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Topics: Design, Errors, Health care, Medical devices, Sphygmomanometers, Testing
Journal Articles

Special Issue: Three-Dimensional Printing of Medical Devices

Kunal Mitra, Prasanna Hariharan
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Guest Editorial
J. Med. Devices. September 2019, 13(3): 030301.
Paper No: MED-19-1094
https://doi.org/10.1115/1.4044259
Published Online: August 16, 2019
View Article titled, Special Issue: Three-Dimensional Printing of Medical Devices
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Topics: Additive manufacturing, Medical devices
Journal Articles

Methodology for Hemodynamic Assessment of a Three-Dimensional Printed Patient-Specific Vascular Test Device

Gavin A. D'Souza, Michael D. Taylor, Rupak K. Banerjee
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. September 2019, 13(3): 031011.
Paper No: MED-19-1066
https://doi.org/10.1115/1.4043992
Published Online: July 15, 2019
View Article titled, Methodology for Hemodynamic Assessment of a Three-Dimensional Printed Patient-Specific Vascular Test Device
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Topics: Additive manufacturing, Flow (Dynamics), Hemodynamics, Pressure, Design, Pressure drop, Medical devices, Anatomy, Testing, Computer-aided design
Journal Articles

Improved Method for the ASTM Platelet and Leukocyte Assay: Use of Minimal Heparinization in a Screening Test for Hemocompatibility of Blood-Contacting Medical Devices

Tim Schatz, Sarah Howard, Deanna Porter, Kent Grove, Mark E. Smith, Yan Chen
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. March 2019, 13(1): 011004.
Paper No: MED-18-1077
https://doi.org/10.1115/1.4041805
Published Online: November 19, 2018
View Article titled, Improved Method for the ASTM Platelet and Leukocyte Assay: Use of Minimal Heparinization in a Screening Test for Hemocompatibility of Blood-Contacting Medical Devices
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Topics: Blood, Leukocytes, Platelets, Medical devices, ASTM International, Rubber, Catheters
Journal Articles

Special Issue: Microscale Medical Devices

Yaling Liu
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Guest Editorial
J. Med. Devices. December 2018, 12(4): 040301.
Paper No: MED-18-1112
https://doi.org/10.1115/1.4040996
Published Online: September 21, 2018
View Article titled, Special Issue: Microscale Medical Devices
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Topics: Medical devices, Microscale devices
Journal Articles

Children and Adults With Rare Diseases Need Innovative Medical Devices

Vasum Peiris, Kui Xu, Heather L. Agler, Eric A. Chen, Rashmi Gopal-Srivastava, Brian M. Lappin, Debra Y. Lewis, Gayatri R. Rao
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. September 2018, 12(3): 034701.
Paper No: MED-18-1024
https://doi.org/10.1115/1.4040489
Published Online: July 13, 2018
View Article titled, Children and Adults With Rare Diseases Need Innovative Medical Devices
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Topics: Biomedicine, Diseases, Medical devices, Pediatrics, Food and Drug Administration
Journal Articles

The Effect of Different Sterilization Methods on Polypropylene Syringes

N. Selcan Turker, A. Yekta Özer, Burak Kutlu, Rahime Nohutcu, Seyda Colak, Melike Ekizoglu, Meral Özalp
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. June 2018, 12(2): 021005.
Paper No: MED-17-1264
https://doi.org/10.1115/1.4039434
Published Online: April 5, 2018
View Article titled, The Effect of Different Sterilization Methods on Polypropylene Syringes
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Topics: Gamma rays, Medical devices, Radiation (Physics), Sterilization, Flow (Dynamics)
Journal Articles

Magnetic Chest Tube Positioning System

Danuel Laan, Trang Ngoc Diem Vu, Matthew Hernandez, Henry Schiller
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Design Innovation Paper
J. Med. Devices. June 2018, 12(2): 025001.
Paper No: MED-17-1275
https://doi.org/10.1115/1.4039208
Published Online: March 5, 2018
View Article titled, Magnetic Chest Tube Positioning System
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Topics: Magnets, Medical devices, Cardiovascular devices, Engineering design processes, Minimally invasive devices, Statistical analysis
Includes: Supplementary data
Journal Articles

Surface and Thermal Characteristics of Single-Use Electrosurgical Pencils After Clinical Reuse and In-Hospital Reprocessing

Francesco Tessarolo, Sebastian Torres, Luis Miguel Ballesteros, Marta Rigoni, Federico Piccoli, Iole Caola, Patrizio Caciagli, Yesid Montoya, Giandomenico Nollo
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. December 2017, 11(4): 041010.
Paper No: MED-17-1037
https://doi.org/10.1115/1.4038145
Published Online: October 20, 2017
View Article titled, Surface and Thermal Characteristics of Single-Use Electrosurgical Pencils After Clinical Reuse and In-Hospital Reprocessing
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Topics: Cables, Coating processes, Coatings, Cycles, Differential scanning calorimetry, Expandable polystyrene, Polymers, Safety, Scanning electron microscopy, Temperature