Jonathan M. Davis

Although electroencephalography (EEG) is used to assess neonatal pain in research settings, EEG assessments have not been sufficiently characterized for use as end points to assess the efficacy of analgesics in regulatory-endorsed, industry-sponsored trials. We aimed to identify all studies conducted in neonates with EEG recordings during acute somatic nociceptive skin-breaking procedures, and to create a network of authors who will be invited to contribute their individual participant data (IPD) to an IPD meta-analysis to establish the validity, reliability, and clinical interpretability of an EEG-based neonatal pain measure. To identify literature, we searched MEDLINE, Embase, CINAHL, Web of Science, Scopus, Google Scholar, ClinicalTrials.gov, and the WHO ICTRP from database inception to July 2, 2025. Eligible studies were primary empirical studies that included neonates with EEG recordings during acute skin-breaking procedures. We identified 55 studies across 11 countries. Heel lance was the most common painful procedure; others included venipuncture, immunization, and lumbar puncture. The impact of 12 analgesic interventions has been studied to date, mostly nonpharmacological interventions. Individual-electrode EEG is more common than EEG caps. We noted relatively high data loss due to EEG data-quality concerns. A wide range of non-EEG pain-relevant measures have been recorded alongside EEG (eg, behavior, vital signs). Coauthorship network analysis highlighted that authors commonly work within discrete authorship hubs, with limited coauthorship across hubs. The predominance of studies was from European and American institutions, which limits generalizability. We conclude that sufficient data are available to undertake an IPD meta-analysis.

Despite widespread and urgent therapeutic need, less than a quarter of new medical devices are developed and approved specifically for children, leaving this growing population with limited treatment options. The System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) framework is an initiative involving many key participants from both the private and public sectors which was developed to address this challenge. SHIP-MD is a multidisciplinary effort with a primary aim to improve the quantity and quality of medical devices that are specifically indicated for use in pediatric populations. The program centers on five priority areas: 1) finance (organizational and operating models; device development funding), 2) hospitals (criteria that hospitals must satisfy in order to participate), 3) navigation (on-boarding of innovators, coordination and management of evidence generation), 4) regulation (refining and optimizing current regulatory processes, recommending new regulatory options), and 5) reimbursement (harmonizing regulatory/reimbursement processes, expediting unique coding to optimize reimbursement, enhancing payments/coverage). SHIP-MD represents a path forward to addressing a long-standing public health matter. The developed framework is feasible and actionable with steps presently being taken to operationalize this national approach. Impact Pediatric device development faces significant challenges including economic disincentives, ethical concerns, and absence of robust advocacy. Potential solutions involve leveraging public-private partnerships to drive innovation. The System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) is an initiative involving the private and public sectors which was conceived to address these multiple challenges and represents an important path forward. The developed framework is feasible and actionable with steps presently being taken to operationalize this national approach. Less than a quarter of new medical devices are developed and authorized specifically for children. Pediatric device development faces significant challenges such as complex funding/reimbursement models and regulatory frameworks. Potential solutions involve leveraging unique public-private partnerships which have been proposed through the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) framework.

Pediatric drug development faces significant challenges, including underfunding, ethical concerns, and complex regulatory frameworks. Despite significant advances in adult drug development, children remain underserved due to their unique physiological needs and difficulties conducting clinical trials. Current pediatric therapeutic options are limited, off-label, and lack evidence from well-controlled trials. Incorporating global regulatory frameworks can provide valuable insights when addressing these challenges. The disparity in investment is evident as several pharmaceutical companies have recently closed their pediatric drug centers with plans to focus on more profitable adult markets, leaving pediatric research underprioritized. This article discusses the root causes of this imbalance and potential solutions including: 1) the use of emerging technologies - artificial intelligence, modeling, and simulation; 2) leveraging innovative trial designs, 3) the use of real-world data, 4) the need for public-private partnerships to drive progress in pediatric drug development; and 5) advocacy groups to shape policies and investments. By focusing on enhancing regulatory incentives, encouraging long-term industry commitment, and engaging patient advocacy groups, a more sustainable pipeline can be established. This call to action underscores the moral imperative of prioritizing pediatric health and fostering innovation to improve outcomes for vulnerable pediatric populations and shape a healthier future for all children. Impact Pediatric drug development faces significant challenges, including underfunding, ethical concerns, and complex regulatory frameworks. The most important causes include the absence of robust advocacy, regulatory hurdles, and economic disincentives. Potential solutions involve leveraging innovative trial designs, the use of real-world data, and public-private partnerships.