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Background <p>Pediatric neurological conditions require specialized devices to address the dynamic physiological and neurological changes from neonates to adolescents. Challenges in developing and regulating these devices arise due to limited pediatric-specific clinical data, high R&amp;D costs, and adult-focused regulatory frameworks. These barriers hinder timely access to essential technologies for children.</p> Objectives <p>To systematically review the development, regulation, and ethical considerations of pediatric neurological devices. The study aims to identify challenges, propose adaptive solutions, and emphasize the need for collaboration among stakeholders to foster innovation and improve health outcomes.</p> Methods <p>A systematic review adhering to PRISMA guidelines analyzed ethical, regulatory, and technical frameworks for pediatric neurological devices. The study included 90 sources, comprising peer-reviewed articles, regulatory guidelines, and expert panel insights. Data were sourced from databases like Scopus and PubMed, focusing on publications between 2016 and 2024.</p> Results <p>Key barriers identified include a lack of pediatric-specific clinical trials, insufficient long-term safety data, and limited market incentives. Ethical complexities such as informed consent, device calibration, and managing unrealistic expectations further complicate device development. The review highlights the potential of adaptive trial designs, real-world evidence, AI, and digital health platforms in expediting device approval and ensuring safety.</p> Conclusions <p>Developing pediatric neurological devices demands a multidisciplinary approach to overcome ethical, regulatory, and technical challenges. Recommendations include integrating adaptive regulatory frameworks, enhancing pediatric-specific R&amp;D tax credits, employing AI-driven maintenance models, and fostering international collaboration. These strategies aim to balance innovation with safety, ensuring equitable access to effective devices for children globally.</p>

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A Systematic Review on Pediatric Neurological Devices: Ethical, Regulatory, and Technical Considerations

  • 期刊论文

  • 发表日期：

    2025年9月4日

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  • Manan Grover,
  • Mansi Sharma,
  • Vikesh Kumar Shukla,
  • Sheffali Gulati,
  • Krishnajit Malakar,
  • Navneet Sharma

摘要

Background

Pediatric neurological conditions require specialized devices to address the dynamic physiological and neurological changes from neonates to adolescents. Challenges in developing and regulating these devices arise due to limited pediatric-specific clinical data, high R&D costs, and adult-focused regulatory frameworks. These barriers hinder timely access to essential technologies for children.

Objectives

To systematically review the development, regulation, and ethical considerations of pediatric neurological devices. The study aims to identify challenges, propose adaptive solutions, and emphasize the need for collaboration among stakeholders to foster innovation and improve health outcomes.

Methods

A systematic review adhering to PRISMA guidelines analyzed ethical, regulatory, and technical frameworks for pediatric neurological devices. The study included 90 sources, comprising peer-reviewed articles, regulatory guidelines, and expert panel insights. Data were sourced from databases like Scopus and PubMed, focusing on publications between 2016 and 2024.

Results

Key barriers identified include a lack of pediatric-specific clinical trials, insufficient long-term safety data, and limited market incentives. Ethical complexities such as informed consent, device calibration, and managing unrealistic expectations further complicate device development. The review highlights the potential of adaptive trial designs, real-world evidence, AI, and digital health platforms in expediting device approval and ensuring safety.

Conclusions

Developing pediatric neurological devices demands a multidisciplinary approach to overcome ethical, regulatory, and technical challenges. Recommendations include integrating adaptive regulatory frameworks, enhancing pediatric-specific R&D tax credits, employing AI-driven maintenance models, and fostering international collaboration. These strategies aim to balance innovation with safety, ensuring equitable access to effective devices for children globally.