UCSF Innovators win over $7 Million in FDA grant to advance medical device development for children!
UCSF Innovators win over $7 Million in FDA grant to advance medical device development for children!
UCSF-Stanford Pediatric Device Consortium (PDC) receives over $7M from FDA (P50FD007967), over the next 5 years, to facilitate development of innovative medical devices specifically for children.
Hanmin Lee, MD, Professor of Surgery, Div. of Pediatric Surgery and Surgeon-in-Chief at UCSF Benioff Children’s Hospitals, along with a team of highly accomplished and experienced innovators from UCSF (Michael Harrison, MD, Professor Emeritus of Surgery; Shuvo Roy, PhD, Professor of Bioengineering and Therapeutic Sciences; Usha Thekkedath, MD, Program Director of Surgical Innovations, Dept. of Surgery; and Willieford Moses, MD, Assistant Clinical Professor of Surgery, Div. of Pediatric surgery) and in collaboration with Stanford team (James Wall, MD; Janene Fuerch, MD and Kunj Sheth, MD), will lead the PDC and its many academic and industry collaborators and an expert advisory network, all passionate about developing innovative technological solutions for pediatric clinical needs.
There is a critical unmet need for novel pediatric devices that are designed explicitly for the unique needs of children and the FDA launched the Pediatric Device Consortia (PDC) Grants Program in 2009, to address this. As an inaugural PDC, UCSF has been a leading institution since 2009 and the 2023 grant award makes UCSF the longest running continually funded consortium of this type, with a successful history in supporting several hundred pediatric devices on their path to commercialization and patient access. In 2018, the UCSF PDC teamed up with Stanford University to expand it to the UCSF-Stanford PDC.
UCSF-Stanford PDC combines the outstanding resources and unique innovation ecosystems available in two world-class universities and two leading children’s hospitals with the unsurpassed entrepreneurial network in the heart of the Bay Area, to equip pediatric innovators at all stages of development to translate their innovations into high-value, commercially viable, and equitable products that are accessible to all populations. The PDC is now further expanding its scope and impact through a partnership with world-class device incubator Fogarty Innovation, the diversification of leadership with actionable plans to promote diversity, equity and inclusion (DEI) in device development, and the expansion of real-world evidence (RWE) consulting and education through a collaborative PDC Service Center as well as a new partnership with a leading RWE firm, Aetion.
UCSF-Stanford PDC, as one of the five centers, will participate in the national program aimed at accelerating the development of and availability of medical devices designed specifically for children. With this grant, the PDC looks forward to further its mission, “to improve health, safety, and quality of life of pediatric patients by accelerating high-value, high impact pediatric device solutions at all stages to the total product lifestyle towards commercialization.”