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Open source approaches for pediatric global health technologies
Ryan C L Brewster1,2, Andrew Wu3, Ryan W Carroll4
1Department of Pediatrics, Boston Children's Hospital, Boston, MA, USA.
Insights
Open-source approaches can accelerate the development of medical technologies for children, especially in low-resource settings. This democratised innovation model balances collaboration with essential safety and quality standards for pediatric global health.
Area of Science:
- Biomedical innovation
- Global health technology
- Pediatric medical devices
Background:
- Advancement of medical technologies for children lags behind adults due to market size, variability, and regulatory challenges.
- Low-resource settings (LRS) face magnified barriers in pediatric innovation, including inadequate regulatory oversight and supply chain capacity.
- The COVID-19 pandemic highlighted limitations in traditional medical technology models and spurred interest in open-source solutions.
Purpose of the Study:
- To explore the potential of open-source approaches to accelerate the development and dissemination of pediatric medical technologies.
- To address the unique barriers in developing and commercializing innovations for children, particularly in low-resource settings.
- To advocate for open-source pathways as a means to foster equitable and sustainable medical innovations for children globally.
Main Methods:
- The study presents a conceptual argument for open-source pathways in pediatric global health.
- It analyzes how open-source models can overcome economic barriers and leverage low-cost manufacturing.
- It discusses the importance of stakeholder engagement and regulatory considerations for open-source medical technologies.
Main Results:
- Open-source approaches can be tailored to clinical needs, are adaptable, and facilitate customization.
- These pathways empower diverse stakeholders, including patients and families, in collaborative innovation.
- Open-source models can address critical equipment shortages and promote equitable access.
Conclusions:
- Open-source strategies offer significant potential to advance equitable and sustainable medical innovations for children worldwide.
- Balancing democratized innovation with safety and quality is crucial for pediatric solutions.
- Coordination between regulatory agencies and decentralized networks can ensure the safety and efficacy of open-source pediatric technologies.
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.
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