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Biomedical Engineering (Tissue Engineering (Biomaterials
(considerations)…
Biomedical Engineering
Medical Tomography
Ionising radiation
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Primary use for imaging structure, anatomy, morphology
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Implications of Motion
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Motion compensation
Excluding, image registration, gating, deconvolution, data-driven approaches, event-by-event based
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Regulatory Affairs
Review
Design control
- design history file (DHF)
- device master record (DMR)
DMR. Specifications, production procedures, equipment and environment requirements
DHF - risk management, inputs, outputs, verification records, validation records, project management
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Technical File
Collection of technical documents, provided for evidence that the device complies with regulations
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Sleep
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2 types of sleep:
- Rapid eye movement (REM)
- Non-REM (NREM)
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Sleep disorders
Insomnia, Sleep related breathing disorders, Central disorders of hypersomnolence, cicadian rhythm sleep-wake, parasomnias (sleep walking), sleep related omvement disorders, other
IMPACTS
Individual: impaired cognition and concentration, negative mood, reduced quality of life, impaired blood pressure and blood sugar control
Societal: increased accident and injury, healthcare utilisation cost, lost productivity, human cost in lost 'wellbeing', total economic burden of $36 billion per annum in Australia
Health risks: poor sleep quality linked to mental disorders, especially depression, and also linked to chronic physical conditions
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Biomanufacturing
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ISO13485 - medical devices: quality of systems, requirements for regulatory purposes
Know what you are building, build it the same way every time, understand the applicable standards, navigate the regulatory environment, target. your approvals, comply with ISO13485.
Advanced Bionics
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Diseases: Retinal degeneration, retenis pigmentosa (RP), age-related macular degeneration (AMD)
Retinal prosthesis located in the supra-choroidal space to stimulate electrode array and leave behind a viable optic nerve
implantation method: sits within a stable "pocket", simplified surgical approach, protection of neurons from stimulation by-products due to physical separation, can co-exist with residual vision.
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Tissue Engineering
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Mechanobiology - study the effects of mechanical forces and geometry on cell growth, motility and functionality
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Ethics
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Ethical Theories
- Ethical Egoism: focus on self-interests, putting safety/health/happiness of the decision. maker ahead of other's, rarely impacts just one individual
- Utilitarianism: Moral or immoral based on consequences
- Duty ethics: Rightness or wrongness of an action is adjudicated according to a set of subjective rules
- Rights Ethics: Ethical decision is one that upholds the rights of all parties to the decision
- Virtue ethics: Ethical if motivated by the virtues of perseverance, courage, compassion and self regard
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