Kevin C. Jiang Department of Biomedical Engineering, University of Michigan, 1101 Beal Avenue, Ann Arbor, MI 48109 e-mail: kcjiang@umich.edu Ibrahim Mohedas Department of Mechanical Engineering, University of Michigan, 2350 Hayward Street, Ann Arbor, MI 48109 e-mail: imohedas@umich.edu Gashaw Andargie Biks Department of Health Systems and Policy, Institute of Public Health, University of Gondar, P.O. Box 196, Gondar 6200, Ethiopia e-mail: gashawab@gmail.com Mulat Adefris Department of Obstetrics and Gynecology, University of Gondar, P.O. Box 196, Gondar 6200, Ethiopia e-mail: mulatadefrisw@gmail.com Takele Tadesse Adafrie 1 Department of Epidemiology and Biostatistics, University of Gondar, P.O. Box 196, Gondar 6200, Ethiopia e-mail: takeletadesse1627@gmail.com Delayehu Bekele Department of Obstetrics and Gynecology, St. Paul’s Hospital Millennium Medical College, P.O. Box 1271, Gulele Addis Ababa 1000, Ethiopia e-mail: dilayehu@yahoo.com Zerihun Abebe Office of the Provost, St. Paul’s Hospital Millennium Medical College, P.O. Box 1271, Gulele Addis Ababa 1000, Ethiopia e-mail: zerihhun@yahoo.com Ajay Kolli Medical School, University of Michigan, 1301 Catherine Street, Ann Arbor, MI 48109 e-mail: kolliaj@umich.edu Annabel Weiner School of Information, University of Michigan, 105 South State Street, Ann Arbor, MI 48109 e-mail: aeweiner@umich.edu Assessing the Usability of a Task-Shifting Device for Inserting Subcutaneous Contraceptive Implants for Use in Low-Income Countries Women in low- and middle-income countries (LMICs) have limited access to long-acting contraceptives. Access to long-acting contraceptives, such as subcutaneous contraceptive implants, could be increased by task-shifting implant administration from advanced to minimally trained healthcare providers. The objective of this study was to investigate the usability of a task-shifting device for administering subcutaneous contraceptive implants. Healthcare providers (n ¼ 128) from multiple health centers in Ethiopia were trained to administer implants on an arm simulator with the traditional method and a method using the device. Participants were observed while inserting implants into the arm simulator, and procedural error rates were calculated. Observations were analyzed using an itera- tive inductive coding methodology. For the device-assisted method, minimally trained healthcare providers had larger procedural error rates than other professions (p ¼ 0.002). For the traditional method, physicians had larger procedural error rates than nurses and midwives (p ¼ 0.03). Several procedural errors were identified such as participants inserting and removing the trocar and plunger completely or inserting and/ or removing the trocar too far or not enough. These findings reinforce the importance of performing formative usability testing during the early phases of a medical device design process, considering users’ mental models, and avoiding assumptions about healthcare providers’ abilities. [DOI: 10.1115/1.4046092] 1 Present address: Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences and Medicine Referral Hospital, Wolaita Sodo University, P.O. Box 138, Wolaita, Ethiopia. Manuscript received August 15, 2019; final manuscript received January 14, 2020; published online February 5, 2020. Assoc. Editor: R. Lyle Hood. Journal of Medical Devices MARCH 2020, Vol. 14 / 011108-1 Copyright V C 2020 by ASME