ENGR 100 Lecture Notes - Lecture 4: Artificial Cardiac Pacemaker, Tissue Engineering, Defibrillation
Document Summary
Brain: deep brain stimulator, spinal cord stimulator. Models : argus 2 bionic eye (60 pixels, 2012 bionic eye 1145 channels and (10,000) pixels require knowledge of the following, materials, biomedical design and technology, biomechanics, biomaterials. Networks of ideas and context for innovation. Design and development of medical devices must comply with iso13485. Design requirements 3d printed implants angle: biology, mechanics, materials, manufacturing, drawing using computer aided design. Two pillars for any biomedical engineer safety and efficacy. Case study 6: brain computer for control of external robotic device (entire exoskeleton is expected to be completed in the year 2030) The two pillars of medical devices development: safety, efficacy. Safety: main aim of the initial testing and pilot trials. Efficacy: evaluation conducted post market (after the device has been in public use for a while. Effectiveness: a measure of the clinical benefit of the device as demonstrated under controlled clinical conditions: iso13485: medical devices-quality management systems.
