Pediatric Medical Device Clinical Trial Unit (MDCTU)
Pediatrics Center for Research Advancement | Baylor College of Medicine
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Our Mission: To accelerate the development and clinical testing of innovative medical devices for children by providing expert guidance, regulatory insight, operational infrastructure, and comprehensive clinical trial support tailored to the pediatric research environment.
About Us
The Pediatric Medical Device Clinical Trial Unit (MDCTU) at Baylor College of Medicine/Texas Children’s Hospital is a new initiative within the Pediatrics Center for Research Advancement, established to support the unique regulatory, ethical, and operational needs of pediatric medical device trials. Created in close collaboration with Baylor College of Medicine/Texas Children’s Hospital and the SWPDC, the MDCTU provides specialized regulatory and operational expertise to ensure the safe, ethical, and effective conduct of clinical trials involving children.
The unit is designed to address the complex challenges of pediatric device development, aiming to accelerate innovation for pediatric populations. As a centralized resource, the MDCTU supports investigators and sponsors conducting pediatric device studies across all phases, including early feasibility, pivotal, and post-market trials.
Who We Support
The MDCTU supports investigators and sponsors through every phase of pediatric device trials and supports the following activities:
Research Grant Budget / Grant Application Assistance, Clinical Trial Cost Assessment and Budget Negotiation, Regulatory Strategy & FDA Engagement, IRB & Ethics Consultation, Study Design & Clinical Trial Operations, Research Nursing/Coordination, Data Management, Quality Assurance – Quality Control, Database Development / Research Information Technology, Medical Writing & Editing, Investigational Product Management, Biostatistics, Bioinformatics, Partnerships & Innovation Infrastructure
The MDCTU is a resource for academic Investigators conducting pediatric device research, clinician innovators seeking to test novel medical technologies, industry Sponsors pursuing pediatric indications, entrepreneurs, and start-ups focused on pediatric device translation
Whether your innovation involves implantable devices, wearable monitors, diagnostics, or AI-enabled tools, the MDCTU is equipped to help you navigate the regulatory and clinical trial landscape for pediatric use.
What We Offer
The MDCTU supports Investigators and Sponsors through every phase of pediatric device trials and supports the following activities:
Research Grant Budget / Grant Application Assistance, Clinical Trial Cost Assessment and Budget Negotiation, Regulatory Strategy & FDA Engagement, IRB & Ethics Consultation, Study Design & Clinical Trial Operations, Research Nursing/Coordination, Data Management, Quality Assurance – Quality Control, Database Development / Research Information Technology, Medical Writing & Editing, Investigational Product Management, Biostatistics, Bioinformatics, Partnerships & Innovation Infrastructure
Contact Chester Koh and R.Brandon Hunter at southwestpdc@bcm.edu to learn more!