P50FD007963

The Consortium for Technology & Innovation in Pediatrics: CTIP 3.0 - Project Summary

The Consortium for Technology & Innovation in Pediatrics (CTIP 3.0) is a pediatric medical device consortium based at Lurie Children’s Hospital (LCH) and Children’s Hospital Los Angeles (CHLA). Established in 2011 and funded by the FDA in 2013 and 2018.

CTIP facilitates the development and commercialization of pediatric medical devices by simultaneously engaging and coordinating clinicians, engineers, regulators, hospital administrators, industry, patients, and the business community to guide and support medical device development for children.

For portfolio companies, CTIP fosters networking opportunities, clinical partnerships, research and evidence generation, and direct and indirect financial support and expert guidance on issues related, but not limited to, intellectual property, prototyping, engineering, testing, grant writing, business development, regulatory strategy, and clinical trial design.

CTIP has established a network of children’s hospitals, academic institutions, accelerators, incubators, and ecosystem partners to support the commercialization of pediatric medical devices. Over the past ten years, CTIP has expanded from Southern California to the entire West Coast and now to a national consortium with academic and industry partners in California, Oregon, Washington, Illinois, Colorado, Michigan, Missouri, and Wisconsin.

CTIP’s overarching goals are:
1) Accelerate pediatric medtech forward, no matter how small or large the step, through non-dilutive funding and comprehensive wrap-around services at every stage of the total product life cycle.
2) Connect pediatric medical device innovators to our national network of experts and multidisciplinary stakeholders to foster research, clinical, and business partnerships.
3) Advocate for pediatric health equity and champion pediatric-specific innovation through research, publications, public events, education, and collaborations.

The systematic barriers to pediatric device innovation are too complex for any one entity to address, so we have worked tirelessly to be effective partners to the other PDCs, the FDA, healthcare organizations, investors, and other ecosystem partners. By coordinating with larger organizations, we multiply our efforts and reach in the field of pediatric medical devices.

For the next funding cycle, CTIP plans to continue to deliver excellent support to all of our portfolio members and expand our activities in four key areas:
1) Business development and follow-on funding opportunities to ensure our companies have the financial runway they need to bring their devices to market.
2) Growing our robust pediatric medical device clinical trials infrastructure and services.
3) Engaging patients and families intentionally as partners in device development and advocacy.
4) Addressing founders’ critical knowledge gaps in healthcare informatics, including data integration, interoperability, cybersecurity, and EHR workflows.

These new activities will help CTIP continue to build a sustainable, needs-driven pipeline of new pediatric medical devices, with the ultimate goal of having more and better devices available on the market that are designed to specifically meet the health needs of children.

ANN & Robert H Lurie Childrens Hospital Of Chicago

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]

Chicago, Illinois 606112991 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.