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Few medical devices are designed and marketed specifically for children. Instead, adult devices are often repurposed and used off-label in pediatrics. The innovation gap between pediatric and adult devices is complex and multifactorial. This review aims to summarize the medical device landscape, describe barriers to pediatric device development, and provide an update on current strategies to help overcome these limitations. Medical devices are regulated by the Food and Drug Administration. They are registered, cleared, or approved on the basis of a 3-tier risk classification system and a differentiated set of regulatory pathways. This includes some for products that receive special designations on the basis of specific aspects that warrant more rapid review and approval. Pediatric devices number only one-quarter of those developed for adults for multiple reasons. Clinically, innovators must adjust their products to address the smaller sizes, growth, and longer duration of use in children. Smaller sample sizes and population heterogeneity also challenge the ability to obtain sufficient safety data for regulatory submissions. Financial concerns stem from lower pediatric reimbursement rates coupled with a lack of nationally standardized coverage. There are a number of promising initiatives, including the Pediatric Device Consortia Program, Early Feasibility Studies, and the new System of Hospitals for Innovation in Pediatrics - Medical Devices. However, the gap will likely not be narrowed without broad cooperation across stakeholders from industry, academia, patient advocacy groups, health care providers, investors, payors, regulators, and Congress., (Copyright © 2022 by the American Academy of Pediatrics.)

Background: The number of racial/ethnic minority children will exceed the number of white children in the USA by 2018. Although 38% of Americans are minorities, only 12% of pediatricians, 5% of medical-school faculty, and 3% of medical-school professors are minorities. Furthermore, only 5% of all R01 applications for National Institutes of Health grants are from African-American, Latino, and American Indian investigators. Prompted by the persistent lack of diversity in the pediatric and biomedical research workforces, the Academic Pediatric Association Research in Academic Pediatrics Initiative on Diversity (RAPID) was initiated in 2012. RAPID targets applicants who are members of an underrepresented minority group (URM), disabled, or from a socially, culturally, economically, or educationally disadvantaged background. The program, which consists of both a research project and career and leadership development activities, includes an annual career-development and leadership conference which is open to any resident, fellow, or junior faculty member from an URM, disabled, or disadvantaged background who is interested in a career in academic general pediatrics., Methods: As part of the annual RAPID conference, a Hot Topic Session is held in which the young investigators spend several hours developing a list of hot topics on the most useful faculty and career-development issues. These hot topics are then posed in the form of six "burning questions" to the RAPID National Advisory Committee (comprised of accomplished, nationally recognized senior investigators who are seasoned mentors), the RAPID Director and Co-Director, and the keynote speaker., Results/conclusions: The six compelling questions posed by the 10 young investigators-along with the responses of the senior conference leadership-provide a unique resource and "survival guide" for ensuring the academic success and optimal career development of young investigators in academic pediatrics from diverse backgrounds. A rich conversation ensued on the topics addressed, consisting of negotiating for protected research time, career trajectories as academic institutions move away from an emphasis on tenure-track positions, how "non-academic" products fit into career development, racism and discrimination in academic medicine and how to address them, coping with isolation as a minority faculty member, and how best to mentor the next generation of academic physicians.

Children with autism spectrum disorder are at increased risk for obesity compared to typically developing children. Many obesity intervention programs exclude children with autism spectrum disorder. There is little research on developmentally inclusive approaches to pediatric weight management. We examined the outcomes of children and families with autism spectrum disorder in an inclusive, comprehensive behavioral family-based lifestyle intervention. A secondary analysis of a randomized controlled trial on families enrolled in a comprehensive behavioral family-based lifestyle intervention was conducted. Analyses included chi-square or Fisher's exact tests to examine family and child differences in program completion rates and multivariate regression analysis using generalized estimating equation to further examine differences in weight outcomes between children with autism spectrum disorder versus no autism spectrum disorder accounting for other covariates. There were 158 families; 15 families had children with autism spectrum disorder. There were no significant differences in demographics, program completion, or weight outcomes between the two groups. Children who completed the intervention had a significant decrease in body mass index Z-scores, but no change in their percentage of the 95th percentiles. Families of children with autism spectrum disorder participated in a comprehensive behavioral family-based lifestyle intervention alongside children without autism spectrum disorder with similar outcomes. Comprehensive behavioral family-based lifestyle intervention can meet the weight management needs of children with autism spectrum disorder using an inclusive approach, expanding access to needed obesity interventions.

ObjectiveThe purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices.MethodsOn August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting.ResultsOne of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices.Discussion/conclusionSeveral proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.

Background: Startup companies in the healthcare sector often fail because they lack sufficient entrepreneurial, regulatory, and business development expertise. Maturity models provide useful frameworks to assess the state of business elements more systematically than heuristic assessments. However, previous models were developed primarily to characterize the business state of larger nonmedical companies. A maturity index designed specifically for startup companies in the medical product sector could help to identify areas in which targeted interventions could assist business development. Methods: A novel MedTech Startup Maturity Index (SMI) was developed by a collaborative team of academic and industry experts and refined through feedback from external stakeholders. Pediatric medical device startups associated with the West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) were scored and ranked according to the SMI following semi-structured interviews. The CTIP executive team independently ranked the maturity of each company based on their extensive experiences with the same companies. Results: SMI scores for 16 companies ranged from 1.2 to 3.8 out of 4. These scores were well aligned with heuristic CTIP rankings for 14 out of 16 companies, reflected by strong correlations between the two datasets (Spearman's rho = 0.721, P = 0.002, and Kendall's tau-b = 0.526, P = 0.006). Conclusions: The SMI yields maturity scores that correlate well with expert rankings but can be assessed without prior company knowledge and can identify specific areas of concern more systematically. Further research is required to generalize and validate the SMI as a pre-/post-evaluation tool. [ABSTRACT FROM AUTHOR]

Digital health is a rapidly developing field which is positioned to transform the manner in which healthcare is delivered, especially amongst adolescents and young adults. In order to assess the efficacy of novel medical devices, clinicians and researchers often turn to the literature for guidance. Randomized control trials and the systematic reviews and meta-analyses that they inform are considered to be at the top of the evidence hierarchy. While they are excellent tools to identify and to summarize the best available evidence to answer a specific research question, they are poorly equipped to provide a more expansive understanding of the body of relevant literature in a timely manner. In this letter we discuss the utility of the scoping review, an underutilized style of academic writing designed to map key concepts in a body of literature. This method is ideal when reporting on the fast-paced field of digital medicine, as it allows for rapid synthesis of the available literature. [ABSTRACT FROM AUTHOR]

Objective. Multi-patient care is important among medical trainees in an emergency department (ED). While resident efficiency is a typically measured metric, multi-patient care involves both efficiency and diagnostic / treatment accuracy. Multi-patient care ability is difficult to assess, though simulation is a potential alternative. Our objective was to generate validity evidence for a serious game in assessing multi-patient care skills among a variety of learners. Methods. This was a cross-sectional validation study using a digital serious game VitalSignsTM simulating multi-patient care within a pediatric ED. Subjects completed 5 virtual "shifts," triaging, stabilizing, and discharging or admitting patients within a fixed time period; patients arrived at cascading intervals with pre-programmed deterioration if neglected. Predictor variables included generic multi-tasking ability, video game experience, medical knowledge, and clinical efficiency with real patients. Outcome metrics in 3 domains measured diagnostic accuracy (i.e. critical orders, diagnoses), efficiency (i.e. number of patients, time-to-order) and critical thinking (number of differential diagnoses); MANOVA determined differences between novice learners and expected expert physicians. Spearman Rank correlation determined associations between levels of expertise. Results. Ninety-five subjects' gameplays were analyzed. Diagnostic accuracy and efficiency distinguished skill level between residency trained (residents, fellows and attendings) and pre-residency trained (medical students and undergraduate) subjects, particularly for critical orders, patients seen, and correct diagnoses (p < 0.003). There were moderate to strong correlations between the game's diagnostic accuracy and efficiency metrics compared to level of training, including patients seen (rho = 0.47, p < 0.001); critical orders (rho = 0.80, p < 0.001); time-to-order (rho = −0.24, p = 0.025); and correct diagnoses (rho = 0.69, p < 0.001). Video game experience also correlated with patients seen (rho = 0.24, p = 0.003). Conclusion. A digital serious game depicting a busy virtual ED can distinguish between expected experts in multi-patient care at the pre- vs. post-residency level. Further study can focus on whether the game appropriately assesses skill acquisition during residency. [ABSTRACT FROM AUTHOR]

OBJECTIVES: This study assessed the state of pediatric medical device (PMD) development by comparing PMD clinical trials to pediatric trials evaluating drugs and biologics, from 1999 to 2022. METHODS: The site www.clinicaltrials.gov was used to identify and quantify both PMD clinical trials and pediatric trials for drugs and biologics. Clinical specialty was also assessed. The institutions included were the 7 children's hospitals primarily affiliated with the Food and Drug Administration (FDA) Pediatric Device Consortia (PDC) grant program between 2018 and 2023. For a national comparison, an additional search assessed PMD trials across all US medical institutions. RESULTS: A total of 243 PMD clinical trials were identified at the FDA-PDC institutions on the basis of the year of initiation; the average number of PMD trials initiated per year per institution was 1.5 from 1999 to 2022. However, PMD trials significantly increased during the period 2014 to 2022 compared with 1999 to 2013 (P < .001); the rate of initiation of drug and biologic pediatric trials demonstrated no significant differences between these time periods. A national survey of all institutions initiating PMD trials, and drugs and biologics trials, identified 1885 PMD trials out of a total 12 943. A comparable trend was noted in the national survey with initiation of PMD trials increasing significantly from 2014 to 2022 (P < .001), compared with 1999 to 2013, whereas the rate of initiation of drug and biologic trials during these periods did not demonstrate a significant change. CONCLUSIONS: Although pediatric clinical trial initiation for drugs and biologics remained stable from 1999 to 2022, the rate of new PMD trials significantly increased during the period 2014 to 2022 at FDA-PDC institutions and nationally. [ABSTRACT FROM AUTHOR]