June 9, 2022
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The National Institute of Child Health and Human Development (NICHD), in collaboration with the National Institute of Biomedical Imaging and Bioengineering (NIBIB), seek comments and input focusing on challenges, gaps, clinical needs, and research opportunities related to Pediatric Medical Devices (PMD) to inform priorities for a Public Private Partnership (PPP) to catalyze the national ecosystem. Such ecosystem will focus on optimizing the translation of technological advancements into medical devices designed, evaluated, and approved for pediatric populations to improve quality of life in this population. These comments are requested from public and private stakeholders such as, but not limited to, innovators, researchers, academic and medical centers, small- and large-scale industries, non-profit organizations, patients, providers, advocacy groups, payors, and federal agencies.
Catalyzing and unifying the national ecosystem around pediatric medical devices will necessitate leveraging collective opportunities, such as through the formation of a multi-stakeholder Public Private Partnership (PPP) to address the existing challenges in development, optimization, and translation of pediatric medical devices.
Despite numerous legislative, regulatory, and scientific efforts of the recent past, there has been little change in the number of devices being developed, reviewed, and/or approved for use in the pediatric population in the United States. The cause of this public health problem is multifold:
Such problems have caused difficulties such as off-label use of devices in children, often without clear instructions or with non-standard modifications that create further complications and risks. Additionally, many conditions for children that could be treated via a device are not pursued. Pediatric patients with serious or life-threatening diseases that are often in greatest need might only have access to an investigational medical device without an appropriate level of evidence.
NICHD and NIBIB seek information and actionable recommendations on research gaps, needs, best practices, innovative study designs and measurement, resources and data resources, and opportunities to inform a PPP to enhance pediatric medical devices space.
Specifically, respondents are asked to briefly address the following topics or categories in the context of Pediatric Medical Devices. Comments are strongly encouraged to address unique challenges of using pediatric medical devices on health disparity populations. NIH defines health disparity populations as racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, sexual and gender minorities (SGM), and any subpopulations that can be characterized by two or more of these descriptions. For more information please refer to NIH definition of Health Disparity.
1. Potential partners to ensure success of public-private partnership to advance the national PMD ecosystem. Some of these challenges pertain, but are not limited to, involvement and integration of:
2. Involvement of Private Industry while considering factors such as:
3. Priorities in Pediatric Medical Device innovation, research, and commercialization such as:
Building inclusive, diverse, and transdisciplinary workforce. For more information on diverse workforce, please refer to the Notice of NIH’s Interest in Diversity (NOT-OD-20-031).
4. Accountability measures to evaluate the program success in areas such as, but not limited to:
5. Clinical Trial infrastructure, data sharing and protocol standardization such as:
6. Reimbursement Challenges for Pediatric Medical Devices:
7. Any other topics which may be relevant for NIH to enhance the national pediatric medical device ecosystem via public-private partnership
How to Submit a Response
All comments must be submitted electronically to email@example.com by Sept 21st, 2022. Responses should be limited to one to two page(s) and marked with this RFI identifier "NOT-EB-22-008" in the email subject line as well as in the title of the response.
Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable information or any information that you do not wish to make public. You may voluntarily include your name and contact information with your response. If you choose to provide NIH with this information, NIH will not share your name and contact information outside of NIH unless required by law. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion. Other than your name and contact information, the Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.
We look forward to your inputs and please feel free to share this RFI with your colleagues.
Afrouz A. Anderson, Ph.D.
National Institute of Biomedical Imaging and Bioengineering
Aaron C. Pawlyk, Ph.D.
NIH Point of Contact for Pediatric Medical Devices
Eunice Kennedy Shriver National Institute of Child Health and Human Development