The Medical Device Clinical Trials Unit (MDCTU), a joint venture of Children’s Hospital Los Angeles Department of Pediatrics and The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP), provides comprehensive and well-coordinated research services for pediatric medical device innovators in industry and academia.
We can support projects across the entire product life cycle, with a special focus on discovery, clinical trials, and real-world data. With our access to expert medical providers and diverse pediatric populations at the top children’s hospital in the Pacific Region, we aim to transform pediatric care and save lives through research and innovation. The MDCTU is housed at Children’s Hospital Los Angeles.
MDCTU-Supported Activities:
Regulatory Strategy
- Pathway to market
- Device classification:
- Breakthrough Devices Program
- Safer Technologies Program (SteP) for medical devices
Clinical Strategy
- Feasibility assessment, clinical study design, site/principal investigator/study population identification
Medical Writing
- Protocol development, consent forms, Investigator’s Brochure (IB), IRB application, contract drafting
FDA Engagement
- Official and unofficial meetings
Contact us if you are:
- Looking for professional guidance in pediatric medical device development
- Pursuing a pediatric indication for your current product, but are hesitant due to regulatory considerations
- Wanting to conduct a clinical study with children but don’t have a connection to medical centers with qualified staff
- Seeking a one-stop shop to expedite pediatric medical device development
Email: MDCTU@chla.usc.edu
Leadership
Greg Zapotoczny, PhD
MDCTU Director
Matt Borzage, PhD
Associate Faculty Director
Join Our Team
- Interested in conducting your medical device research at CHLA?
- Would you like to learn more about our ongoing studies?
- Want to join our team?
CRC I/II - We are looking for a highly motivated Clinical Research Coordinator to join our team and work with various industry stakeholders to support medical device clinical trials. If interested, please contact: MDCTU@chla.usc.edu.