Medical Device:

World Health Organization defines a Medical Device as, “any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of: Diagnosis, prevention, monitoring, treatment.

Classification of Medical Devices

By definition, a medical device is any “article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose” (World Health Organisation). This includes something a simple as an adhesive bandage, artificial body parts (prostheses), any surgical, diagnostic or monitoring equipment/devices, as well as advanced, implanted devices such as pacemakers and neurostimulators.

Device Trials

Medical device evaluation, especially for high-risk and implantable devices, is associated with multiple methodological and interpretative challenges. At the DCRI, our expertise in device research spans from Phase I studies through post-market surveillance. Our faculty members and research and operational teams work with experts from industry, government, and academia to conduct device studies in every therapeutic area. For device trials, we offer the following services.

Device Trial Services

• Protocol Development
• Project Management
• Site Management
• Site Monitoring
• Risk-Based Monitoring
• Patient Recruitment and Retention
• Data Management
• Statistical Programming, Analysis and Reporting
• DSMB Oversight and Coordination
• Regulatory Oversight and Compliance
• Medical Writing
• Quality Assurance

Devices

Medical device clinical trials are different from drug trials in that only patients with the condition which the device is designed to treat are involved. They are traditionally comprised of three different types of studies.

1. Exploratory or Feasibility Study - Exploratory studies (also known as feasibility studies) are conducted in the early stages of device development. They are used to establish preliminary safety and effectiveness of the device and design the next stage of the trial, the pivotal study.
2. Pivotal Study - Pivotal studies are performed to demonstrate the device is safe and effective for a specific use within a defined patient population. The results of a pivotal study are used to gain regulatory approval to market the device.
3. Postmarket Study - Run either as a condition of approval to meet a business objective, post-market studies are similar to Phase IV of clinical drug trials since the goal is to better understand long-term effectiveness of the device and potential adverse events associated with the use of the device.

Thanks and Regards,

Alpine

Associate Editor

Journal of Clinical Trials

clinicaltrials@eclinicalsci.com