Alliance for Pediatric Device Innovation (APDI) Pediatric Heart Condition RFP

Alliance for Pediatric Device Innovation (APDI) Pediatric Heart Condition RFP is a grant opportunity from the Alliance for Pediatric Device Innovation, led by Children's National Hospital in collaboration with Additional Ventures, that funds the development of medical devices to diagnose, treat, and monitor pediatric patients with heart conditions.

Individual grants of up to $50,000 are available, with up to $300,000 in total program funding. Priority areas include AI-based algorithms for cardiac diagnosis or treatment, wearable devices for continuous monitoring, remote patient monitoring systems, and minimally invasive technologies for cardiac procedures.

Startup entities, established businesses, and academic researchers working on child-centric, pediatric-specific device solutions are eligible to apply.

Request for Proposal Medical Devices to Address Pediatric Heart Conditions – NCCPDI Request for Proposal Medical Devices to Address Pediatric Heart Conditions The Alliance for Pediatric Device Innovation (APDI), led by Children’s National Hospital, in collaboration with Additional Ventures, has opened a grant opportunity for pediatric medical devices to diagnose, treat, and monitor pediatric patients with heart conditions.

Grants up to $50,000 each are available for pediatric-specific solutions selected by a panel of experts from submitted proposals. Up to $300,000 in grant funds are available for distribution through this program. Children with heart conditions face unique challenges that demand specialized medical devices tailored to their specific physiological needs.

In the fields of cardiology, cardiac surgery, and electrophysiology, there is a significant unmet need for pediatric devices designed to monitor and treat young patients effectively. Current technologies often fall short, as they are typically adapted from adult devices and may not provide the accuracy, safety, or comfort required for children.

Areas of special interest include remote patient monitoring systems that can track vital signs and heart function in real-time, wearable devices designed for continuous monitoring, and minimally invasive technologies for cardiac procedures.

This RFP seeks innovative solutions that address these gaps, offering the potential to revolutionize care for pediatric patients with heart conditions through the development of advanced, child-centric devices. The kinds of pediatric-focused innovations the grant seeks to fund, and which are aligned with NACDA’s listed priorities.

They include, but are not limited to, the following: • Artificial intelligence-based algorithms that collect, integrate, analyze and visualize various types of data related to the diagnosis or treatment of pediatric heart conditions. • Wearables and connected digital therapeutics intended to detect, diagnose and treat pediatric patients with heart conditions for at-hospital or at-home monitoring.

• Non-contact monitoring devices for at-hospital use in intensive care units.

• Non-invasive or minimally invasive devices used in the perioperative cardiac care of pediatric patients Submission deadline – 9a EST on September 23rd, 2024 Finalists announced – September 30th, 2024 | Finalists must commit to present live on October 14, 2024 in Toronto, Canada, during Children’s National’s 12th Annual Symposium on Pediatric Device Innovation Winners announced – October 14, 2024 The Alliance for Pediatric Device Innovation (APDI), led by Children’s National Hospital, in collaboration with Additional Ventures, has opened a grant opportunity for pediatric medical devices to diagnose, treat, and monitor pediatric patients with heart conditions.

Grants up to $50,000 each are available for pediatric-specific solutions selected by a panel of experts from submitted proposals. Up to $300,000 in grant funds are available for distribution through this program. Children with heart conditions face unique challenges that demand specialized medical devices tailored to their specific physiological needs.

In the fields of cardiology, cardiac surgery, and electrophysiology, there is a significant unmet need for pediatric devices designed to monitor and treat young patients effectively. Current technologies often fall short, as they are typically adapted from adult devices and may not provide the accuracy, safety, or comfort required for children.

Areas of special interest include remote patient monitoring systems that can track vital signs and heart function in real-time, wearable devices designed for continuous monitoring, and minimally invasive technologies for cardiac procedures.

This RFP seeks innovative solutions that address these gaps, offering the potential to revolutionize care for pediatric patients with heart conditions through the development of advanced, child-centric devices. The kinds of pediatric-focused innovations the grant seeks to fund, and which are aligned with NACDA’s listed priorities.

They include, but are not limited to, the following: • Artificial intelligence-based algorithms that collect, integrate, analyze and visualize various types of data related to the diagnosis or treatment of pediatric heart conditions. • Wearables and connected digital therapeutics intended to detect, diagnose and treat pediatric patients with heart conditions for at-hospital or at-home monitoring.

• Non-contact monitoring devices for at-hospital use in intensive care units. • Non-invasive or minimally invasive devices used in the perioperative cardiac care of pediatric patients Applications are to be submitted through the CoLab platform . Once started, applications can be saved and edited up to the submission deadline.

The person starting the application (the “Primary Applicant”) can invite collaborators to assist in completing the application. The application includes the following sections to be completed online: b. Lead Applicant Name, Title, and Email Address c.

Company, Institution, or School and Department and Geographic Location d. Institutional Point of Contact and Notification email address (if different) e. Requested Award Amount (please note that indirect costs are not allowed) g.

Abstract – A short executive summary (250 words maximum) 2. Description of the unmet need and proposed solution. Describe the unmet need and why the current standard of care fails to address the needs of the pediatric population.

Please address morbidity, mortality, costs, and/or other metrics of the problem. Provide an overview of your proposed solution. What is it (a device, software as a medical device, etc.), how it works, and what makes it unique and better than the available and emerging options.

If you have it, please provide evidence that the solution may work.. Describe the benefits the solution will have on the treatments, services, or preventative interventions that relate to improvement in pediatric healthcare. To the degree possible, estimate the number of patients impacted, cost savings, or other metrics of success.

d. Current Maturity Level Please use the CIMIT Healthcare Innovation Cycle to characterize the current maturity of your solution by selecting the level that best describes the development status in each of the four key domains. Please upload a PDF with a short description of your proposed solution (under 2 pages) with images, data, etc. to help the reviewers understand what you are proposing.

Please upload a document with references and citations in support of the description of the proposed project. Please limit to one page 3. Description of the proposed workplan, team, and resources a.

Deliverables and Workplan Describe up to 5 Deliverables from the work to be done. For each, outline the expected results, why it is important, how completing this work advances the commercialization of the solution and the approximate % of the budget it represents Describe your core project team members, their roles, brief overview expertise and relevant prior experience, and approximate % level of effort. c.

Resources and Environment Describe the resources and environment your team will have available to complete the work proposed. 4. Implementation Pathway Describe your general approach for moving the solution through to commercialization including the anticipated regulatory pathway, reimbursement strategy, and go-to-market plan.

Provide an outlook describing potential non- and dilutive sources of future funding beyond this program. Describe your market analysis to date. Please include a description of potential competitors and/or competing technologies or practices.

5. Budget & Budget Justification Provide an itemized budget for funds requested. Eligible budget categories include prototype production, data collection and analysis, clinical and pre-clinical studies, testing, consultants, quality systems development, materials, and personnel support.

Grants cannot exceed $50,000 and do not include overheads. Provide a justification for the proposed budget. The Alliance for Pediatric Device Innovation (APDI) is seeking proposals from inventors in the established businesses, startup entities, and academic researchers who have medical device concepts or ideas for use with pediatric patients.

Proposals should address a significant, yet unmet need within the pediatric population with a device idea that lends itself to commercialization. The proposal should be directed towards development of a market-ready product, not research of a scientific concept. Issues such as prototyping, manufacturing, marketing, and FDA regulatory clearance or approval will be paramount and should be addressed explicitly.

The FDA Pediatric Device Consortia grant program places special emphasis on helping bridge the gap that often follows the prototyping phase, as the promising medical devices must also be manufactured, cleared or approved by the FDA, marketed, and sold. Therefore, we enthusiastically welcome projects that are past the initial prototyping phase.

Review Process and Scoring Criteria Scoring by the NCC-PDI Review Committee and Pediatric Device Development Panel will be based on an assessment of the following factors: 1. clinical significance of the pediatric device 2. approach to product development 3.

likelihood of being marketed successfully 4. project team, environment, and resources 5. potential for additional funding This seed grant funding is intended to promote the commercialization of a medical device for children.

The application should include a description of the long term funding strategy. The success of this grant program will be measured by advancement through the product development progress, generation of intellectual property, clinical trials progress, steps toward FDA clearance or approval, follow-on funding, and clinical impact.

Publications arising from a grant funded by this program are required to acknowledge APDI as the source of funding. Awardees will be required to submit three quarterly progress reports and a final report. This information will be used in APDI’s updates to the FDA and must be submitted in a timely fashion.

Investigators that do not submit this report will be at risk of losing continued funding support. Applicants must be up to date with, or able to obtain Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval for work proposed, if applicable. Any additional relevant certifications (FWA numbers, CITI certifications, etc.) must be made available upon request.

In cases of exceptional products, competitive renewals may be considered based on progress of the previously funded project. Investigators may request an informal review before submission of a renewal application. Innovation Competition Applications must be submitted directly to the program via the web and do not need institutional sign-off at this phase of the competition.

Applications should be submitted through the online CoLab system APDI is structured to provide critical mass for clinical, regulatory, business, scientific, and engineering expertise. apdi@childrensnational. org