Alexander Steele ’28
Medical devices play a crucial role in the diagnosis and treatment of disease in children, but the development, testing, and approval of pediatric devices lags behind that of adult technology. Despite the reality that delivery rooms and neonatal intensive care units are technology-heavy care settings, the Food and Drug Administration’s 2017 report to Congress indicated that only 9% of approved devices were labeled for infants and neonates.1 Due to this gap, providers often repurpose adult devices for off-label applications. Along with increasing the risk of health complications in young patients, this practice also limits the data available on the safety and efficacy of pediatric-specific technologies.1 This means that providers are left with limited options to prevent, treat, or palliate pediatric disease.2
In order to support the development of more pediatric-specific solutions, several barriers stand to be addressed. Firstly, the unique and rapidly changing physiology of children, including factors such as development, and age-related variations in organ function, complicates device design. In addition, some technologies cannot be miniaturized for use in smaller individuals, and devices that expand with a child’s growth can be difficult to engineer. For example, children with congenital heart disease may require 3 to 5 surgeries over their lifetime so that fixed-size prosthetic valves or shunts can be replaced as the patient grows.1 Additionally, the unique daily activities of children can cause unexpected problems with devices. For instance, in the early 2000s, several electronic failures of cochlear implants in children were caused by the discharge of static electricity as children slid down plastic slides in winter snowsuits.1 Regulatory and ethical considerations can also pose challenges, as study blinding can be difficult to ensure with small populations, and patients can be difficult to recruit for trials if parents are hesitant. Finally, financial issues represent a significant barrier to the success of pediatric device development. Market uncertainties abound with a highly inconsistent reimbursement landscape and around 50% of children receiving coverage from Medicaid, whose coverage decisions are made at the state level.1 Funding sources for pediatric devices are also limited due to the relatively small population size and lower device usage when compared to the adult population.3
Several strategies have been suggested to address these barriers, including measures to increase funding opportunities, reform regulatory disincentives, develop a supportive ecosystem, and advocate for legislative changes.1 In the United States, efforts to close the innovation gap have been spearheaded by the Pediatric Device Consortia (PDC) program at the Food and Drug Administration (FDA), which funds nonprofit associations across the country that provide pediatric device innovators with the capital and expertise necessary for product development and validation.2 Several institutions have also launched their own initiatives to accelerate innovation, including the University of Minnesota, which created the Pediatric Device Innovation Consortium (PDIC) in 2011. PDIC partnered with the Office of Discovery and Translation (ODAT) to implement three different funding programs to identify unmet pediatric needs and areas for potential innovation, support the progress of pioneering solutions, and form key partnerships that advance device development.2 The first two of these programs, The Device Development and Industry-Academic Collaborative Programs, provide innovators of pediatric technologies seeking to gain experience in technology development not only funding, but access to a project team or group of advisory experts that fills in the gaps of the innovator’s expertise.2 The Community Discovery Program solicits descriptions of addressable unmet medical needs and challenges from the perspective of patients and caregivers, allowing the voices which are oftentimes least represented to stimulate innovation of needed solutions.2
For each of these programs, the PDIC is able to offer a continuum of support, ranging from consultations to strategic guidance and funding due to its structure, which includes dedicated program staff, cross-disciplinary project advisory experts, and a network of service providers.2 The operational structure of the PDIC is shown below in Figure 1.
Figure 1: The Pediatric Device Innovation Consortium (PDIC) operational structure and support network supports development of pediatric medical technologies. The PDIC draws on both internal and external experts for various operational functions, including project and opportunity evaluation, product development strategies, and completion of milestones.2
The impact of the PDIC’s efforts has been evident, as 70% of the 22 projects which they have funded have advanced to later stages in development as a result of the support.2 Of these, two technologies have reached the market, including Let’s Yonder, a software company that takes on pediatric dental anxiety with a recently released app featuring a cartoon hippo named “Mimi” that virtually guides children through their dentist office prior to their first appointment.2
In 2023, the PDIC became a member of the Southwest-Midwest National Pediatric Device Innovation Consortium (SWPDC), which is an accelerator that brings together Texas A&M University, Rice University, University of Houston, University of Minnesota, local device development firms, and other children’s hospitals.5 The SWPDC has had great success in its mission to support pediatric device innovators in their efforts to develop and commercialize much-needed pediatric medical devices. For example, WiscMed, one of the companies in the SWPDC’s portfolio, recently produced a commercially-available digital otoscope which combines unique speculum geometry and touch-screen capabilities to deliver an expanded view of the ear canal and easily shared images of the tympanic membrane.5
In spite of the recent progress in addressing physiologic, regulatory, technical, and financial hurdles that pediatric device innovators face, the gap between the development of pediatric and adult medical devices still persists. The programs at PDIC demonstrate a model that shows how an academic institution can increase support for local pediatric innovation and contribute to the national effort to close the pediatric technology gap.2 Broad cooperation across stakeholders from industry, academia, patient advocacy groups, health care providers, investors, payors, and regulators is what makes these consortia possible,1 and this cooperation is necessary to improve the care of children in need of specific device solutions.
Alexander Steele is a staff writer at The Princeton Medical Review. He can be reached at as3034@princeton.edu.
References
1. Espinoza J, Shah P, Nagendra G, Bar-Cohen Y, Richmond F. Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities. Pediatrics. 2022;149(5):e2021053390. doi:10.1542/peds.2021-053390
2. Fischer GA, Wells SM, Rebuffoni JF, Peterson BM, LeBien TW. A model for overcoming challenges in academic pediatric medical device innovation. J Clin Transl Sci. 2019;3(1):5-11. doi:10.1017/cts.2019.370
3. Sun RC, Kamat I, Byju AG, et al. Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding. J Pediatr Surg. 2021;56(11):2118-2123. doi:10.1016/j.jpedsurg.2021.01.025
4. Warren H. BCM, TCH Southwest Pediatric Device Consortium receives FDA grant. Baylor College of Medicine. https://www.bcm.edu/news/bcm-tch-southwest-pediatric-device-consortium-receives-fda-grant. Published October 2, 2023.
5. Portfolio companies. SWPDC. https://swpdc.org/portfolio-overview-draft/. Published July 8, 2024.
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