Medical Device Clinical Trials Unit (MDCTU)

Introduction

The Medical Device Clinical Trials Unit (MDCTU) 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 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.

‍

Supported activities

Regulatory Strategy

Pathway to market; Device classification; Breakthrough Device Program and Safer Technologies Program

Clinical Strategy

Feasibility assessment; Clinical study design; Site selection; PI engagement; Study populations identification

Medical Writing

Protocol development; Consent forms; Investigator Brochure; IRB application; Drafting budgets and contracts

FDA Engagement

Facilitate official and unofficial meetings with the regulatory agency

‍

Contact us if you are

• Looking for professional guidance in pediatric medical device development
• Pursuing pediatric indication for your current product, but 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
  

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. Please follow the link for CRC Job Description. If interested, please fill out the MDCTU CRC Application.

‍

Contact us

With any other questions please feel free to email us at MDCTU@chla.usc.edu