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Journal Articles

Gravity Augmented Fused Filament Fabrication Additive Manufacturing

John M. Huss, Arthur G. Erdman

Publisher: ASME

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

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

Publisher: ASME

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

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 ]

Publisher: ASME

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 ]

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

Publisher: ASME

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

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

Publisher: ASME

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

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

Publisher: ASME

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

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

Publisher: ASME

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

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

Publisher: ASME

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

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

Publisher: ASME

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

Topics: Design, Errors, Health care, Medical devices, Sphygmomanometers, Testing

Journal Articles

Special Issue: Three-Dimensional Printing of Medical Devices

Kunal Mitra, Prasanna Hariharan

Publisher: ASME

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

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

Publisher: ASME

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

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

Publisher: ASME

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

Topics: Blood, Leukocytes, Platelets, Medical devices, ASTM International, Rubber, Catheters

Journal Articles

Special Issue: Microscale Medical Devices

Yaling Liu

Publisher: ASME

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

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

Publisher: ASME

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

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

Publisher: ASME

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

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

Publisher: ASME

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

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

Publisher: ASME

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

Topics: Cables, Coating processes, Coatings, Cycles, Differential scanning calorimetry, Expandable polystyrene, Polymers, Safety, Scanning electron microscopy, Temperature

Journal Articles

Assessing the Importance of Surgeon Hand Anthropometry on the Design of Medical Devices

Michael Stellon, Drew Seils, Christine Mauro

Publisher: ASME

J. Med. Devices. December 2017, 11(4): 041004.

Paper No: MED-16-1340

https://doi.org/10.1115/1.4037257

Published Online: August 17, 2017

View Article titled, Assessing the Importance of Surgeon Hand Anthropometry on the Design of Medical Devices

Topics: Design, Medical devices, Surgery, Wounds, Instrumentation

Journal Articles

Effects of Sterilization on Shape Memory Polyurethane Embolic Foam Devices

Rachael Muschalek, Landon Nash, Ryan Jones, Sayyeda M. Hasan, Brandis K. Keller, Mary Beth B. Monroe, Duncan J. Maitland

Publisher: ASME

J. Med. Devices. September 2017, 11(3): 031011.

Paper No: MED-16-1296

https://doi.org/10.1115/1.4037052

Published Online: June 28, 2017

View Article titled, Effects of Sterilization on Shape Memory Polyurethane Embolic Foam Devices

Topics: Foams (Chemistry), Shapes, Sterilization, Urethane elastomers, Medical devices, Fourier transform infrared spectroscopy, Temperature, Water, Mechanical testing

Journal Articles

Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

Gumei Liu, Eric Chen, Debra Lewis, Gayatri Rao

Publisher: ASME

J. Med. Devices. September 2017, 11(3): 034701.

Paper No: MED-16-1350

https://doi.org/10.1115/1.4036333

Published Online: June 27, 2017

View Article titled, Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

Topics: Diseases, Drugs, Food and Drug Administration, Food products, Safety, Medical devices

Journal citation

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Supplemental Material

Gravity Augmented Fused Filament Fabrication Additive Manufacturing

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

“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 ]

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

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

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

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

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

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

Special Issue: Three-Dimensional Printing of Medical Devices

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

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

Special Issue: Microscale Medical Devices

Children and Adults With Rare Diseases Need Innovative Medical Devices

The Effect of Different Sterilization Methods on Polypropylene Syringes

Magnetic Chest Tube Positioning System

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

Assessing the Importance of Surgeon Hand Anthropometry on the Design of Medical Devices

Effects of Sterilization on Shape Memory Polyurethane Embolic Foam Devices

Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

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