Device—First in Human

This section outlines First In Human (FIH) studies, a critical phase in medical device development to assess safety, biological interactions, and initial efficacy in humans. These trials are essential for ensuring regulatory compliance and paving the way for larger clinical trials and market approval.

MDCE provides end-to-end FIH support, including study design, regulatory strategy, and clinical trial management. Leveraging global expertise and innovative approaches, we help clients execute compliant, efficient studies to accelerate market access.

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Introduction to First In Human (FIH) Studies

  • What is First In Human

First In Human (FIH) studies mark the transition from pre-clinical testing to human trials. These early-phase studies evaluate the safety, biological interactions, and initial efficacy of medical devices in humans, providing foundational data for subsequent clinical trials and regulatory submissions. FIH studies are essential for identifying potential risks, validating performance, and refining device usage before advancing to larger-scale trials.

  • Challenges in First In Human

FIH studies face significant challenges, including ensuring patient safety and obtaining reliable data from a small cohort. These initial trials require meticulous planning and rigorous oversight to meet stringent regulatory standards. Another major difficulty is the recruitment and retention of participants, as the risks and benefits of new treatments are not yet fully understood, demanding extensive resources and careful management.

  • Key Benefits of First In Human

First In Human (FIH) studies are crucial for ensuring regulatory compliance, providing essential data to meet FDA, MDR and global standards. This data offers initial insights into device safety and efficacy, and helps optimize future study designs based on real-world evidence.

Moreover, these studies allow for early risk identification, enabling timely device adjustments that improve development outcomes. This proactive risk management helps accelerate the development process, significantly speeding up the path to market approval.

Core Services From MDCE for FIH Studies

Comprehensive Study Design and Regulatory Support

MDCE designs robust First In Human (FIH) study protocols and Investigator’s Brochures, ensuring alignment with regulatory requirements and trial objectives. We streamline approval processes by managing Investigational Device Exemption (IDE) submissions to the FDA and Clinical Investigation Applications to EU Notified Bodies and global authorities.

Clinical Trial Management and Execution

MDCE oversees all aspects of FIH trials, including site selection, contracting, patient recruitment, monitoring, and data collection. Our team ensures efficient execution, minimizing delays while maintaining the highest quality standards.

Safety Monitoring and Data Analysis

MDCE prioritizes participant safety with rigorous monitoring and prompt reporting of adverse events. Post-trial, we conduct detailed data analysis, delivering actionable insights and comprehensive reports to support regulatory submissions.

Core Advantages of MDCE

MDCE combines global expertise, regulatory excellence, and innovative solutions to deliver superior First In Human (FIH) studies. With a proven track record across the US, EU, and Asia-Pacific, we ensure seamless execution, strict compliance, and accelerated timelines, empowering clients to achieve faster market access while maintaining the highest standards of quality and patient safety.

Global Experience Across Regions

MDCE leverages its extensive global experience to conduct First In Human (FIH) studies across key regions, including the US, EU, and Asia-Pacific. This expertise ensures seamless execution and timely progress in diverse regulatory and healthcare environments.

Regulatory Expertise and Compliance

Our team’s deep understanding of regulatory standards, such as FDA and EU MDR requirements, ensures that all FIH studies meet stringent compliance criteria. We deliver end-to-end support, from regulatory submissions to trial monitoring, ensuring smooth navigation through complex approval processes.

Innovative Approaches for Quality and Safety

By utilizing cutting-edge technologies and methodologies, MDCE enhances study quality and prioritizes patient safety. Our innovative strategies streamline processes while maintaining data integrity and compliance with global standards.

Accelerated Study Timelines

MDCE’s fast-track processes enable clients to advance quickly through critical clinical milestones. This efficient approach significantly shortens the FIH study timeline, helping clients achieve faster regulatory approval and market access.

Case Studies and Project Experience

MDCE is a trusted partner for First-In-Human (FIH) clinical studies, offering end-to-end support to ensure regulatory compliance, robust safety monitoring, and efficient trial execution. With a wealth of experience across diverse regions, including the US, EU, and Asia-Pacific, we specialize in accelerating early-phase trials for innovative medical devices while maintaining the highest standards of quality and patient safety.

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TGM FIH study of gastroenterology device for the treatment of patients with hepatic fibrosis 
Prospective, open-label, single arm clinical study to evaluate the safety and performance of the medical device class IIb

Key Outcomes:

  • The preliminary results of evaluation of adverse events and complications related to the device confirmed the device is safe and tolerable.
  • Assessment of device performance shows the device operates well in a clinical setting. This included measuring functionality, accuracy, reliability, and consistency in achieving intended results.
  • Evaluation of the device’s usability by healthcare professionals and patients demonstrated the device is easy to use.

  • Measurement of relevant clinical endpoints is underway.

 

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Ready to Begin Your First In Human Study?

If you are preparing to advance your innovative medical device into human clinical trials, MDCE is here to support you. Our expert team offers comprehensive services, from regulatory submissions to trial management, ensuring the success of your FIH study.

Contact Information:
Phone: 0512-6280 1222
Email: ask@mdcecro.com
Address: Room 2003-1, Building 2, Huihu Building, No. 10 Moon Bay Road, Suzhou Industrial Park, Suzhou City

MDCE’s global experience in First In Human studies, combined with our expertise in regulatory strategy and clinical trial management, ensures that your device progresses smoothly through this critical phase of development. Partner with us to fast-track your medical device’s journey from pre-clinical testing to real-world clinical success.