P50FD007961

Midwest Pediatric Device Consortium (MPDC) - Summary

The Midwest Pediatric Device Consortium (MPDC) has been created to address unmet needs in pediatric medical device development. Founded at Nationwide Children's Hospital (NCH) and The Ohio State University (OSU) in Columbus, Ohio, MPDC will use funds from the FDA Pediatric Device Consortia (PDC) program in support of its mission to provide funding and business, legal, organizational, clinical, engineering, and scientific resources to inventors of pediatric medical devices having significant commercialization potential and that address pediatric health needs.

NCH and OSU both maintain national prominence in clinical care and research. Teaming with other pediatric healthcare organizations including Cincinnati Children's and Cleveland Clinic Children's establishes a vibrant and comprehensive medical device development ecosystem for our region and provides diversity in leadership, participation, community engagement, and economic opportunity.

MPDC is also powered by Ohio's trade organizations, including Jobs Ohio and Ohio Life Sciences, to leverage their network of connections and state legislative influence. Lastly, MPDC engages with several venture funds including Rev1 Ventures, CincyTech, and Project MedTech, having considerable resources and experience bringing startup companies forward.

Participating organizations of the MPDC have already assisted a large number of devices along the development pathway, demonstrating the business experience and stewardship of ideas necessary for programmatic success. The full range of support is offered to innovators by the MPDC network, comprised of preeminent experts in their field who will provide advice, education, guidance, and funding to help lead device development through the pipeline to commercial success.

Our executive committee and advisory committee are made up of clinicians, scientists, business, and manufacturing experts who are thought-leaders in their fields. They will evaluate the clinical and business merits of every device project submitted for evaluation and funding.

MPDC's organizational structure includes a broad spectrum of leaders who are able to assess the value proposition, reimbursement, regulatory, marketing, and business strategy of each proposed device as a cost-free service.

MPDC will implement its comprehensive plan to foster collaboration, diversity, equity, and inclusion as a leader in creating a national network benefiting all pediatric patients. MPDC will also provide unique real-world evidence through projects specifically crafted to capture data streams as well as develop mechanisms to collect new data to support pediatric device label expansion.

MPDC will be a beacon of pediatric medical device innovation through its bridging of academic researchers, inventors, entrepreneurs, and industry partners in an integrative program to transform pediatric healthcare through advancement of new and needed technologies.

Research Institute At Nationwide Children's Hospital

TO ASSIST INSTITUTIONS AND ORGANIZATIONS, TO ESTABLISH, EXPAND, AND IMPROVE RESEARCH, DEMONSTRATION, EDUCATION AND INFORMATION DISSEMINATION ACTIVITIES, ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), BIOLOGICS, BLOOD AND BLOOD PRODUCTS, THERAPEUTICS, VACCINES AND ALLERGENIC PROJECTS, DRUG HAZARDS, HUMAN AND VETERINARY DRUGS, CLINICAL TRIALS ON DRUGS AND DEVICES FOR ORPHAN PRODUCTS DEVELOPMENT, NUTRITION, SANITATION AND MICROBIOLOGICAL HAZARDS, MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS, RADIATION EMITTING DEVICES AND MATERIALS, FOOD SAFETY AND FOOD ADDITIVES. THESE PROGRAMS ARE SUPPORTED DIRECTLY OR INDIRECTLY BY THE FOLLOWING CENTERS AND OFFICES: CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER), CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), CENTER FOR VETERINARY MEDICINE (CVM), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR), THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OPD), THE CENTER FOR TOBACCO PRODUCTS (CTP), AND OFFICE OF REGULATORY AFFAIRS (ORA), AND THE OFFICE OF THE COMMISSIONER (OC). SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMS: TO STIMULATE TECHNOLOGICAL INNOVATION, TO ENCOURAGE THE ROLE OF SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION BY MINORITY AND DISADVANTAGED PERSONS IN TECHNOLOGICAL INNOVATION. FUNDING SUPPORT FOR SCIENTIFIC CONFERENCES THAT ARE RELEVANT TO THE FDA SCIENTIFIC MISSION AND PUBLIC HEALTH ARE ALSO AVAILABLE.

93.103 - Food and Drug Administration Research

FDA Office of Acquisition and Grant Services (OAGS) [HHS - FDA]

FDA Office of the Commissioner [HHS - FDA]

Columbus, Ohio 432052664 United States

Single Zip Code

Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional (RFA-FD-23-024)

Amendment Since initial award the total obligations have increased 200% from $1,150,000 to $3,450,000.