Program Director/Principal Investigator (Last, First, Middle): Koh, Chester Project Summary / Abstract: A great need currently exists for medical devices designed specifically for children, where this gap is most likely a result of economic, clinical, regulatory, reimbursement and business model challenges as well as a lack of established mechanisms for connecting pediatric device ideas with qualified individuals / programs and industry partners who can effectively assist in the development and commercialization efforts. In addition, pediatric medical devices also need to accommodate the unique pathophysiology and anatomy of pediatric patients. The Southwest Pediatric Device Consortium based at Texas Children’s Hospital and Baylor College of Medicine supports pediatric device innovators with product and technology acceleration services and business acceleration services both regionally and nationally, with the goal of commercialization and clinical use of novel pediatric medical devices. The consortium includes clinical, scientific, business, financial, regulatory, reimbursement, engineering, ISO13485 compliant product design & manufacturing, intellectual property, and academic partners in the Houston / Southwest U.S. region, including Texas A&M University, Rice University, University of Houston, local device development firms, and other children’s hospitals in the Southwest U.S. region. The consortium facilitates the development of pediatric medical devices by coordinating resources within its existing translational and commercialization framework. The consortium recognizes that pediatric device projects may need an extended life cycle in the children’s hospital / academic setting before exposure to the external market, where the faculty, students, and resources of major children's hospitals can partner with established engineering design teams at major research universities to identify unmet pediatric device needs, assemble clinical faculty and engineering design team partnerships, and then develop and test new pediatric device prototypes that can be developed into viable pediatric medical devices. The consortium will also help to increase awareness around the need for novel pediatric medical device development, as well as identify and address current barriers to the development and commercialization of pediatric devices with a particular focus on establishing a productive needs-driven pipeline of new pediatric medical devices. The consortium networks its stakeholders with the business, investment, higher education, and philanthropic communities in the entire Southwest U.S. region in order to provide pediatric innovators with comprehensive pediatric device development services. Furthermore, the consortium’s Real World Evidence demonstration project proposal represents a collaboration between a large children’s hospital health system, Texas Children’s Hospital and Baylor College of Medicine, and a National Science Foundation-funded Engineering Research Center, PATHS-UP at Texas A&M, with an aligned focus on remote monitoring for diabetes mellitus in underserved pediatric populations. OMB No. 0925-0001/0002 (Rev. 01/18 Approved Through 03/31/2020) Page Continuation Format Page

Program Director/Principal Investigator (Last, First, Middle): Koh, Chester Project Narrative: The Southwest Pediatric Device Consortium’s goals are to utilize a multi-disciplinary network of stakeholders at Texas Children’s Hospital / Baylor College of Medicine and affiliated Southwest U.S. institutions and local device development partners, as well as the business and investment communities, to provide pediatric device innovators with product and technology acceleration services and business acceleration services to promote the development of pediatric devices that address critical unmet needs through the consortium’s extensive advisory network as well as direct device funding. It is anticipated that public health will benefit from the sustainable and productive needs-driven pipeline of new pediatric devices that will arise with assistance given to pediatric device innovators from the consortium at all stages to progress toward commercialization and clinical implementation. OMB No. 0925-0001/0002 (Rev. 01/18 Approved Through 03/31/2020) Page Continuation Format Page