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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

Reducing Leak and Increasing Comfort of an N95 Filtering Facepiece Respirator for Aged-Care Workers Using a Customized, Soft, and Compliant Mask Frame

Darius Chapman, Campbell Strong, Dhani Dharmaprani, Prabhpreet Kaur, Kathryn Tiver, Anand N. Ganesan
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. June 2024, 18(2): 021006.
Paper No: MED-24-1012
https://doi.org/10.1115/1.4065614
Published Online: June 11, 2024
View Article titled, Reducing Leak and Increasing Comfort of an N95 Filtering Facepiece Respirator for Aged-Care Workers Using a Customized, Soft, and Compliant Mask Frame
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Topics: Filtration, Respirators, Health care, Testing
Includes: Supplementary data
Journal Articles

Preclinical Evaluation of a Task-Shifting Contraceptive Implant Insertion Device for Use in Low- and Middle-Income Countries

Ibrahim Mohedas, Carrie Bell, Delayehu Bekele, Kevin Jiang, Caroline Soyars, Madeleine Walsh, Kathleen H. Sienko
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. December 2022, 16(4): 044501.
Paper No: MED-21-1116
https://doi.org/10.1115/1.4054684
Published Online: June 16, 2022
View Article titled, Preclinical Evaluation of a Task-Shifting Contraceptive Implant Insertion Device for Use in Low- and Middle-Income Countries
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Topics: Design, Pressure, Testing, Health care, Skin, Pressure testing, Biological tissues, Blood, Ultrasound, Performance
Journal Articles

Clinical Evaluation of an Automatic Oxygen Control System for Premature Infants Receiving High-Flow Nasal Cannula for Respiratory Support: A Pilot Study

Xuefeng Hou, Akram Faqeeh, Ramak Amjad, John Pardalos, Roger Fales
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. September 2022, 16(3): 031005.
Paper No: MED-20-1201
https://doi.org/10.1115/1.4054250
Published Online: May 10, 2022
View Article titled, Clinical Evaluation of an Automatic Oxygen Control System for Premature Infants Receiving High-Flow Nasal Cannula for Respiratory Support: A Pilot Study
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Topics: Automatic control, Control systems, Flow (Dynamics), Oxygen, Health care
Journal Articles

Protective Masks Utilizing Nonendangered Components

Linsey Griffin, Minji Yu, Alison Cloet, Susan Arnold, Neil Carlson, Marc Hillmyer, Qisheng Ou, Chenxing Pei, Qingfeng Cao, David Pui, Rhonda Franklin, William Durfee
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Design Innovation Paper
J. Med. Devices. March 2022, 16(1): 015001.
Paper No: MED-21-1189
https://doi.org/10.1115/1.4053720
Published Online: March 2, 2022
View Article titled, Protective Masks Utilizing Nonendangered Components
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Topics: Design, Filters, Filtration, Health care, Manufacturing, Testing, Pandemics, Teams
Journal Articles

Positive Pressure Testing Booths Development and Deployment in Response to the COVID-19 Outbreak

Kevin Aroom, Jiawei Ge, Lidia Al-Zogbi, Marcee White, Adrienne Trustman, Adena Greenbaum, Jason Farley, Axel Krieger
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. March 2022, 16(1): 011001.
Paper No: MED-21-1004
https://doi.org/10.1115/1.4052515
Published Online: February 3, 2022
View Article titled, Positive Pressure Testing Booths Development and Deployment in Response to the COVID-19 Outbreak
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Topics: Biomedicine, Design, Health care, Pressure, Pressure testing, Safety, Testing, Air conditioning, Particulate matter, Risk
Journal Articles

The Effect of Chemical Cleaning on Mechanical Properties of Three-Dimensional Printed Polylactic Acid

Julie C. Fleischer, Jan C. Diehl, Linda S. G. L. Wauben, Jenny Dankelman
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. March 2020, 14(1): 011109.
Paper No: MED-19-1133
https://doi.org/10.1115/1.4046120
Published Online: February 11, 2020
View Article titled, The Effect of Chemical Cleaning on Mechanical Properties of Three-Dimensional Printed Polylactic Acid
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Topics: Additive manufacturing, Cycles, Design, Mechanical properties, Stiffness, Stress, Surface quality, Weight (Mass), Biomedicine, Health care
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: 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

Diagnostics as the Key to Advances in Global Health: Proposed Methods for Making Reliable Diagnostics Widely Available

David Melander, Sudesh Sivarasu, Ibrahim Yekinni, Cheng Yunzhang, Arthur Erdman
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. March 2020, 14(1): 014702.
Paper No: MED-19-1129
https://doi.org/10.1115/1.4046046
Published Online: February 5, 2020
View Article titled, Diagnostics as the Key to Advances in Global Health: Proposed Methods for Making Reliable Diagnostics Widely Available
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Topics: Diseases, Governments, Health care, Health systems, Testing, Non-governmental organizations, Performance, Biomedicine
Journal Articles

Improving Healthcare Access: A Preliminary Design of a Low-Cost Arm Rehabilitation Device

Davide Piovesan, Santhosh Kumar Shanmugam, Yuvarajan Arumugam, Adam Restifo, Corey Jackson, Nicholas Devine, Kristine Legters
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research-Article
J. Med. Devices. March 2020, 14(1): 011103.
Paper No: MED-19-1109
https://doi.org/10.1115/1.4045964
Published Online: January 31, 2020
View Article titled, Improving Healthcare Access: A Preliminary Design of a Low-Cost Arm Rehabilitation Device
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Topics: Design, Engineering prototypes, Finite element analysis, Linkages, Simulation, Springs, Stiffness, Equilibrium (Physics), Stress, Compression
Journal Articles

Value-Based Care: A Review of Key Challenges and Opportunities Relevant to Medical Technology Innovators

Véronique Peiffer, Cynthia A. Yock, Paul G. Yock, Jan B. Pietzsch
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Review Articles
J. Med. Devices. June 2019, 13(2): 020801.
Paper No: MED-18-1140
https://doi.org/10.1115/1.4042794
Published Online: March 6, 2019
View Article titled, Value-Based Care: A Review of Key Challenges and Opportunities Relevant to Medical Technology Innovators
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Topics: Biomedicine, Health care, Performance
Journal Articles

Automated Real-Time Processing of Single Lead Electrocardiogram for Simultaneous Heart Rate and Respiratory Rate Monitoring

Disha N. Dutta, Reshmi Das, Saurabh Pal
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. June 2017, 11(2): 024502.
Paper No: MED-16-1274
https://doi.org/10.1115/1.4035982
Published Online: May 3, 2017
View Article titled, Automated Real-Time Processing of Single Lead Electrocardiogram for Simultaneous Heart Rate and Respiratory Rate Monitoring
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Topics: Algorithms, Arrhythmias, Belts, Design, Electrodes, Engineering prototypes, Errors, Signals, Stairs, Data acquisition
Journal Articles

Thematic Framing: Creating Healthcare Innovations

Minke Dijkstra, Willem Mees van der Bijl
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Special Section Technical Briefs
J. Med. Devices. June 2016, 10(2): 020962.
Paper No: MED-16-1148
https://doi.org/10.1115/1.4033199
Published Online: May 12, 2016
View Article titled, Thematic Framing: Creating Healthcare Innovations
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Topics: Design, Framing (Construction), Health care, Structural frames, Biomedicine, Cancer
Journal Articles

Improvement of Mobile Device Connectable Bioelectrical Impedance Analyzer

Byung Ho Choi, Jung Min Kim, Youn Ho Shin, Gyungcheol Choi, Jung Hun Choi
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Special Section Technical Briefs
J. Med. Devices. June 2016, 10(2): 020967.
Paper No: MED-16-1185
https://doi.org/10.1115/1.4033288
Published Online: May 12, 2016
View Article titled, Improvement of Mobile Device Connectable Bioelectrical Impedance Analyzer
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Topics: Batteries, Computer software, Electrodes, Errors, Health care, Reliability, Weight (Mass), Shapes, Aluminum, Accuracy and precision
Journal Articles

Assistive Device for the Insertion of Subcutaneous Contraceptive Implants

Ibrahim Mohedas, Amir Sabet Sarvestani, Corey Bertch, Anthony Franklin, Adam Joyce, Jacob McCormick, Michael Shoemaker, Carrie Bell, Timothy Johnson, Dilayehu Bekele, Senait Fisseha, Kathleen Sienko
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. June 2015, 9(2): 020943.
Paper No: MED-15-1136
https://doi.org/10.1115/1.4030220
Published Online: June 1, 2015
View Article titled, Assistive Device for the Insertion of Subcutaneous Contraceptive Implants
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Topics: Biological tissues, Blood, Design, Engineering prototypes, Health care, Pressure, Skin, Needles, Teams
Journal Articles

Critical and Complex Technological Capability Development for Health Care Delivery: Multiyear Field Study of a Surgical (da Vinci) Robot in a Multispecialty Hospital

Ujjal Kumar Mukherjee, Shoubhik Sinha, Scott Bosch, Kingshuk K. Sinha
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. September 2014, 8(3): 030928.
Paper No: MED-14-1079
https://doi.org/10.1115/1.4027073
Published Online: July 21, 2014
View Article titled, Critical and Complex Technological Capability Development for Health Care Delivery: Multiyear Field Study of a Surgical (da Vinci) Robot in a Multispecialty Hospital
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Topics: Robots, Surgery, Health care
Journal Articles

A Wearable Posture Detection Device for Inpatient Healthcare

Nhat Nguyen Vo, Haoyong Yu
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. September 2014, 8(3): 030948.
Paper No: MED-14-1122
https://doi.org/10.1115/1.4027115
Published Online: July 21, 2014
View Article titled, A Wearable Posture Detection Device for Inpatient Healthcare
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Topics: Health care, Sensors
Journal Articles

Redesigning the UK Emergency Ambulance

Ed Matthews, Gianpaolo Fusari, Yusuf Muhammad, Dale Harrow, Peter Stevens, Richard Winsor, Jonathan Benger, Dixie Dean, Lord Ara Darzi, Dominic King
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technical Briefs
J. Med. Devices. September 2013, 7(3): 030933.
Paper No: MED-13-1095
https://doi.org/10.1115/1.4024484
Published Online: July 3, 2013
View Article titled, Redesigning the UK Emergency Ambulance
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Topics: Design, Emergencies, Teams, Health care, Testing