Abstract：
Access to medical technologies is a critical component of universal access to care; however, the advancement of technologies for children has historically lagged behind those for adults. The small market size, anatomic and physiologic variability, and legal and ethical implications pose unique barriers to developing and commercialising paediatric biomedical innovations. These challenges are magnified in low-resource settings (LRS), which often lack appropriate regulatory oversight, support for service contracts, and supply chain capacity. The COVID-19 pandemic exposed shortcomings in the traditional industry model for medical technologies, while also catalysing open-source approaches to technology development and dissemination. Open-source pathways - where products are freely licenced to be distributed and modified - addressed key shortages in critical equipment. Relatedly, we argue that open-source approaches can accelerate paediatric global health technology development. Open-source approaches can be tailored to clinical challenges independent of economic factors, embrace low-cost manufacturing techniques, and can be highly customisable. Furthermore, diverse stakeholders, including families and patients, are empowered to participate in collaborative communities of practice. How to regulate the development, manufacture, and distribution of open-source technologies remains an ongoing area of exploration. The need for democratised innovation must be carefully balanced against the imperatives of safety and quality for paediatric-specific solutions. This can be achieved, in part, through close coordination between national regulatory agencies and decentralised networks where products can be peer-reviewed and tested. Altogether, there is significant potential for open source to advance more equitable and sustainable medical innovations for all children.
摘要：
获得医疗技术是普遍获得护理的关键组成部分；然而，儿童技术的进步历来落后于成人。市场规模小，解剖和生理变异性，以及法律和道德影响对开发和商业化儿科生物医学创新构成了独特的障碍。这些挑战在低资源环境(LRS)中被放大，往往缺乏适当的监管监督，支持服务合同，和供应链能力。COVID-19大流行暴露了传统医疗技术行业模式的缺陷，同时也促进技术开发和传播的开源方法。开源途径-产品可以自由许可分发和修改-解决了关键设备的关键短缺。相关地，我们认为，开源方法可以加速儿科全球卫生技术的发展。开源方法可以独立于经济因素而适应临床挑战，拥抱低成本制造技术，并且可以高度定制。此外，不同的利益相关者，包括家属和病人,被授权参与合作社区的实践。如何规范发展，制造,开源技术的分发仍然是一个正在进行的探索领域。对民主化创新的需求必须与针对儿科特定解决方案的安全和质量的必要性进行仔细平衡。这是可以实现的,在某种程度上,通过国家监管机构和分散网络之间的密切协调，产品可以进行同行评审和测试。总之,开源在为所有儿童推进更公平和可持续的医疗创新方面具有巨大潜力。
