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Designing Medical Devices is a Course

Designing Medical Devices


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Full course description

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute - SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Basic considerations for designing medical device trials such as device complexity and limitations, resource constraints, availability of a control group, and key stakeholders (i.e., hospital administration, radiologists, and clinicians) will be discussed. Characteristics unique to medical devices will be further explored via case studies using adaptive trial design for device testing.

At the end of this course, the learner will:

1.      Understand the basic considerations for designing medical device trials, e.g., proof of device safety and/or efficacy, device size, ethics, device costs, study controls, partnerships with hospitals and industry, and study endpoints.

2.      Define adaptive trial design, identifying the advantages and disadvantages for using adaptive trial design for medical device studies.


Course Topics

          1.         When do we do device trials?

          2.         Necessity of strong partnerships

          3.         Transcatheter versus transapical implants

          4.         Adaptive design trials

          5.         Registries versus trials