References
- Hwang TJ, Kesselheim AS, Bourgeois FT. Postmarketing trials and pediatric device approvals. Pediatrics. 2014;133(5):e1197–e1202. doi: 10.1542/peds.2013-3348.
- Reiner RC, Olsen HE, Ikeda CT, GBD 2017 Child and Adolescent Health Collaborators., et al. Diseases, injuries, and risk factors in child and adolescent health, 1990 to 2017: findings from the global burden of diseases, injuries, and risk factors 2017 study. JAMA Pediatr. 2019;173(6):e190337. doi: 10.1001/jamapediatrics.2019.0337.
- World Health Organization. WHO Compendium of Innovative Health Technologies for Low-Resource Settings: 2021: COVID-19 and Other Health Priorities. World Health Organization; 2021. Accessed June 29, 2022. https://apps.who.int/iris/handle/10665/344504.
- NEST360. Committed to Reducing Neonatal Mortality 2020. https://www.nest360.org/clinical-and-technical-education.
- Espinoza J, Shah P, Nagendra G, et al. Pediatric medical device development and regulation: Current state, barriers, and opportunities. Pediatrics. 2022;149(5):e2021053390. doi: 10.1542/peds.2021-053390.
- Premarket approval of pediatric uses of devices. Washington (DC): Food and Drug Administration, Department of Health and Human Services; 2017.
- Jenkins KJ, Beekman RH, Vitale MG, Section on Cardiology and Cardiac Surgery, Section on Orthopaedics., et al. Off-Label use of medical devices in children. Pediatrics. 2017;139(1):e20163439. doi: 10.1542/peds.2016-3439.
- Pearce JM. A review of open source ventilators for COVID-19 and future pandemics. F1000Res. 2020;9:218. doi: 10.12688/f1000research.22942.1.
- Bhaskar S, Tan J, Bogers MLAM, et al. At the epicenter of COVID-19–the tragic failure of the global supply chain for medical supplies. Front Public Health. 2020;8:562882. doi: 10.3389/fpubh.2020.562882.
- Corsini L, Dammicco V, Moultrie J. Critical factors for implementing open source hardware in a crisis: lessons learned from the COVID-19 pandemic. Journal of Open Hardware. 2020;4(1):8. doi: 10.5334/joh.24.
- Open Source Hardware Association. https://www.oshwa.org/.
- Costa CGA, Leão BF, Moura LA. São paulo city health information system–a case report. Stud Health Technol Inform. 2007;129(Pt 1):377–381.
- deRiel E, Puttkammer N, Hyppolite N, et al. Success factors for implementing and sustaining a mature electronic medical record in a low-resource setting: a case study of iSanté in Haiti. Health Policy Plan. 2018;33(2):237–246. doi: 10.1093/heapol/czx171.
- Verma N, Mamlin B, Flowers J, et al. OpenMRS as a global good: impact, opportunities, challenges, and lessons learned from fifteen years of implementation. Int J Med Inform. 2021;149:104405. doi: 10.1016/j.ijmedinf.2021.104405.
- Frazer JS, Shard A, Herdman J. Involvement of the open-source community in combating the worldwide COVID-19 pandemic: a review. J Med Eng Technol. 2020;44(4):169–176. doi: 10.1080/03091902.2020.1757772.
- Garmendia O, Rodríguez-Lazaro MA, Otero J, et al. Low-cost, easy-to-build noninvasive pressure support ventilator for under-resourced regions: open source hardware description, performance and feasibility testing. Eur Respir J. 2020;55(6):2000846. doi: 10.1183/13993003.00846-2020.
- Pearce JM. Economic savings for scientific free and open source technology: a review. HardwareX. 2020;8:e00139. doi: 10.1016/j.ohx.2020.e00139.
- Mandavilli A. Make anything, anywhere. Nature. 2006;442(7105):862–864. doi: 10.1038/442862a.
- Vijayavenkataraman S, Fuh J, Lu W. 3D printing and 3D bioprinting in pediatrics. Bioengineering. 2017;4(3):63. doi: 10.3390/bioengineering4030063.
- Flynn R, Walton S, Scott SD. Engaging children and families in pediatric health research: a scoping review. Res Involv Engagem. 2019;5(1):32. doi: 10.1186/s40900-019-0168-9.
- UNICEF. A Voice for Every Child through Open-Source Solutions and Resources: supporting Complex Communication Needs with Inclusive Innovations.; 2022. https://www.unicef.org/innovation/stories/giving-every-child-voice-aac-technology.
- De Maria C, Di Pietro L, Díaz Lantada A, et al. Safe innovation: on medical device legislation in Europe and africa. Health Policy and Technology. 2018;7(2):156–165. doi: 10.1016/j.hlpt.2018.01.012.
- Chao TE, Mody GN. The impact of intellectual property regulation on global medical technology innovation. BMJ Innov. 2015;1(2):49–50. doi: 10.1136/bmjinnov-2014-000033.
- World Health Organization. Medical devices: managing the mismatch: an outcome of the priority medical devices project. Published online 2010. Accessed November 9, 2022. https://apps.who.int/iris/handle/10665/44407.
- Pietro LD, De Maria C, Ravizza A, et al. Co-design open-source medical devices: how to minimize the human error using UBORA e-infrastructure. In: 2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE; 2019:3730–3733. doi: 10.1109/EMBC.2019.8856891.
- Digital Square. Digital Square. Accessed September 1, 2023. https://digitalsquare.org/.