Biomedical engineering notes exam prep (Auto Recovered) PDF

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Biomedical engineering notes: Week 1 ▪

Biomedical Engineering Program largest in southern hemisphere, 650 students total and 600 undergraduates with 50 graduate masters. ▪ 5 disciplines within the school of AMME (Biomedical, Mechanical, Mechatronic and Aeronautical ▪ Largest engineering school after civil engineering Biomedical enginering education team: 1. Professor Andrew Ruys- Director of Biomed Eng 2. Professor Qing Li- Biomedical eng director (education) 3. Program manager/ 1st year advisor – Dr Phillip Boughton 4. 2nd year advisor Professor Gregg Suaning 5. 3rd Year advisor: Dr Yogambha (Yogi) ramaswamy 6. Final year advisor +exchange professor Colin Dunstan CUSP: is the roadmap Sydney Student is the Vehicle

Week 1-2: The healthcare Sector Spine service Test Lab: i. Biomechanics Studies ii. Implant testing iii. General multi axis testing iv. In situ analysis (x-ray/MRI) v. Wear test/ Characterisation (Orthopaedic Research institute department of orthopaedic Surgery and Sports Medicine) IOS Class 7- Clean room manufacturing: Min requirements for class 2 or 3 long term implants 1. Engineering design and development (ISO13485) 2. Materials, mechanics, manufacturing 3. Quality management systems 4. Microbiology, biocompatibility, physical analysis

Diverse career options for biomedical engineering 1. Clinical engineering (hospital based) Healthcare sector i. Hospitals and clinics ii. Allied health iii. Medical research institutes iv. Public health, Governance

v.

Regulatory agencies

2. Medtech Industry i. Startup device companies ii. Design and manufacture iii. In-surgery support iv. Maintenance and repairs v. Consulting and guidance vi. Clinical and regulatory affairs vii. Product distribution and logistics viii. Implant and device testing Non-medical Bioengineering: 3. Biotech industries i. Pharmaceuticals ii. Device packaging iii. Analytical labs iv. Sterilisation v. Food tech vi. Supplements vii. Environmental safety viii. Renewable materials ix. Disinfection and cleaning

Roles of Biomedical engineers in hospitals and medical centre? -

Managing and auditing quality and safety in healthcare facilities In-surgery technical support for tools, devices and implants Orthopaedics patient gate analysis, biomechanics studies and testing Rehabilitation engineering/support with custom devices, braces, frames and cuffs Prosthetics and orthotics design, fabrications, customisation Managing design build and maintenance of surgical theatres Medical imaging installation, handling, processing or correction Radiation oncology/medical physics/ dosimetry and calibration installation, repairs and preventative maintenance of medical equipment 3d printing for pre-surgical planning and custom implant templating infection control, cleaning and sterilisation departments failure analysis and risk management IP management and research management Training and education of clinical staff or patients and supporters Electronic records infrastructure and data analysis Clinical trials for validating safety and efficacy of medical device technologies.

Royal prince Alfred hospital 1. RPA linked opportunities a. RPA biomedical engineering b. Clarles perkins centre c. Institute of rheumatology or orthopaedics d. Lifehouse cancer centre e. Institute of Academic surgery f. Centenary institute Regional and rural health 1. Visiting GPs and mobile clinics 2. Health charities (e.g sight for all, fred hollows) 3. Accessible health solutions Healthcare -

Not confined to hospital beds and buildings Preventative approaches Real time monitoring instead of intermittent Interdisciplinary remote care Proactive patient participation Portals to cloud analytics and dashboard Evidence based medicine and health management Sustainability, transparency, continuum or personalised care

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Equity and accessibility, regional, global Shift from purely risk management to innovation opportunities

Tutorial task Week 1: 1. Choose and review one area of healthcare interest and generate a basic one page bullet summary 2. List one question you would like to find an answer to in this area 3. Include a sentence explaining how an engineer may engage in this area 4. Include 3-5 supporting references. List them at the bottom of the page using IEEE standard referencing.

Tutorial Task 1 Tutorial Week 2 Mon: 2-3pm

By: Cassandra Soliman

Tissue Pathology and Diagnostic Oncology - This particular department specialises in the diagnosis and treatment of a plethora of cancerous tumours that attack the mechanism of often main connective tissue and muscle functionality. Common tumours that are presented frequently in this particular ward include: - Soft Tissue Sarcomas are evidently a group of heterogeneous rare tumours that are presented to originate from the embryonic mesoderm, often described as an asymptomatic mass [Cornier et al. [1].] that can likely affect any area of the body in particular (trunk wall, intraabdominal/ intrathoracic space, retroperitoneum, head and neck). - Tissue pathology and diagnostic oncology as a dynamic unit undergo a series of pre-treatment radiologic imaging in order to assess the criticality of the presented tumour and it ensures accuracy in determining the stage of the disease, guiding biopsies as well as aiding the diagnostic process [Arbiser et al. [3].]. - Additionally, a grading process is utilised to attain an arbitrary estimate of the degree of Malignancy presented in the tumour, which aid prognostic prediction and treatment as well as determining acute therapy requirements [Cornier et al. [1].]. - The diagnostic procedural steps also help classify the soft tissue sarcomas in the following groups benign (non-cancerous), malignant and intermediate malignant tumours. - This ward places a significant amount of classified research in precursor lesions, pathogenesis, histopathology, molecular pathology and prognostic/ predictive biomarkers for many diseases including expected behaviourism of the condition [Miettinen.[2].]. - The department of tissue pathology and diagnostic oncology is currently focused on uncovering the multi-potential precursor cells such as stem cells in order to instigate a transformative treatment for all forms of tissue and muscle sarcomas. New research demonstrated the impact of stem cells on replenishing soft tissue components, an example of this existing manifestation is the regeneration of Skeletal muscle cells founded in their origins in bone marrow, including a portion of endothelial progenitor cells are evidently of bone marrow stromal origins [Miettinen .[2].].

- A phenomenal amount of research in this area of medicine have attempted to trace the epidemiological origins as well as the etiologic factors contributing to aiding the increase in soft tissue sarcomas recent factual analysis has pointed to three major elements: ionising radiation, oncogenic viruses and chemicals. All of which stipulate into environmental factors rooting the incline in these diseases [Cornier et al. [1].].

List one question you would like to find an answer to in this area? One question that I would like to find an answer to in this area, is how we can develop viable treatment that is non-invasive aside from radiation as well as therapies to reverse the supposed irreversible effects of soft tissue damage that occurs due to the disease itself and detrimental treatment processes aiding further destruction? Include a sentence explaining how an engineer may engage in this area? An engineer can have an extraordinary engagement in the area of tissue pathology and diagnostic oncology as potential solutions such as devices to aid and replenish natural mechanical movement as well as producing a targeting treatment delivery system that could potential not affect the patient’s complete quality of life.

References: 1. J. Cormier et al., “Soft Tissue Sarcomas”, vol. 54, no. 2, pp. 94-109, 2004. [Online]. Avaliable: http://CAonline.AmCancerSoc.org 2. M. Miettinen, Modern Soft Tissue Pathology: Tumors and Non-Neoplastic Conditions, Cambridge University Press, 2010. 3. Z. Arbiser et al., “Consultative (Expert) Second Opinions in Soft Tissue Pathology: Analysis of Problem-Prone Diagnostic Situations”, vol. 116, no. 4, pp. 473-476, 2015. [Online]. Avaliable: http://doi.org/10.1309/425HNW4W-XC9A-005H.

Week 2 lecture 1 notes: Biomedical engineering is booming - Fastest growing branch of engineering in the world - Ranked recently as number 1 best job in America - Aging population and the biotechnology boom - In Australia, the manufacturing industry shrinking. Areas for engineering Growth are biomedical engineering and mining sectors The global biomedical industry 1. Medical devices: span 3 principal areas, with biology and engineering the two unifying themes i. Mechanical engineering (biomedical technology, biomanufacturing and biomedical device design ii. Mechatronic/electrical engineering (electrical-medical equipment, bionics and signal processing) iii. IT/computing engineering (medical imaging, computational simulation) 2. Biotechnology and pharmaceuticals: are a domain of chemical and manufacturing engineering Biotechnology: any technological application that uses biological systems, living organisms, or derivatives thereof to make to modify products or processes for specific use (biochemistry, bioprocessing, biomaterials, tissue engineering, biomedical devices, pharmaceuticals) Pharmaceutical industry: industry dedicated to manufacture and distribution of legal therapeutic drugs Definition of MEDICAL DEVICE: Any technology intended to be used by human beings for the prevention, monitoring or treatment of a disease, injury or physiological process, including Device, software and diagnostics.

GLOBAL MEDICAL DEVICE INDUSTRY: ➢ Valued over 250 billion a year, fastest growing markets in the world, with projected growth over 10 percent a year, 25 multinational companies account for more than 50 percent of the global market devices. Companies include 1. Zimmer 2. Abbot 3. Johnson and Johnson 4. Stryker 5. Medtronic (in total there are thousands of companies globally) Currently the major markets for medical devices are in the USA, Europe and Japan

Asian markets for medical devices are growing rapidly. Predicted that Asian markets will overtake those of Europe and north America within 15 years, presenting Australia with a significant Geographic advantage. The Australian Medical Device industry: - Earned export revenue of 3 billion dollars with an additional 5 billion spent on imports - Comprises about 1,100 companies - 250,000 + product - Turnover in Australia of US6 billion dollar Australian medical device industry, include medical devices, invirto diagnostics and medical imaging equipment including: Disease screening technologies, therapies, equipment supplies, everything from expensive, complex capital equipment (such as x-rays, machines and MRI scanners) - 2 giant companies ResMed and Cochlear - hundreds of small to medium sized companies which often a single niche product - Asia Pacific headquarters of large global companies, importers and distributors

Case study 1. Hip Replacements ▪

Earliest record of total Hip Arthroplasty was first noted in 1891 in Germany presented at the 10th international medical conference Professor Themistocles Gluck. ▪ 1925 the American Surgeon Marius Smith Petersen created first mold Arthroplasty out of glass ▪ English orthopaedic surgeon Sir John Charnley who worked at the Manchester Royal Infirmary (considered father of the modern Hip Arthoplasy. Junior Science Math Biology Junior/ intermediate engineering: Mechanics Materials Electronics Anatomy and physiology Senior Biomedical Engineering Biomedical design and technology Biomanufacturing Biomechanics Biomaterials Biomedical Specialised electives MECH5907 AMME4681

AMME5992 AMME5931 AMME4990 Case study 2 LVAD- Left Ventricular Assist device Reasons why each UOS might be relevant to this technology o Turbocharger for the Heart o Simulating blood flow to the heart o Requires CFD- Computational Fluid dynamics o Created in the 1990’s o Magnetically levitating pump impeller suspended in blood sophisticated electronic and software control o Electronics for suspending it utilising a magnetic field Junior Science Math Chemistry Biology Junior/intermediate engineering: Mechanics Material Electronics Anatomy and Physiology Senior Biomedical Engineering Biomedical design and technology Biomanufacturing Biomechanics Biomaterials Biosignal processing Biomedical specialist electives MECH5701 MECH4720 ELEC5614 ELEC3305 ELEC5514

Case study 3 Tissue Engineered Kidney Information of tissue engineered kidney - Hundreds of millions of people globally need donor organs - 100,000,000.00 kidney dialysis (portable kidney) tissue engineered kidney (UK made a giant leap) Professor Melissa Little and Team created the first (BORGANIOD) - first stem cell reprogramming from fibroblast cell - from stem cell to 12 different kidney cell types - 5-6milli-litres across and 100 filtered units The key enabling invention Professor Shinya Yamanaka (2006) japan- won noble prize for stem cell reprogramming kidney (out of skin graft) Focused attaining Plori-potent Stem Cells: produced by reprogramming all cells forming humans Risks involved were: A. Casakogeric Adult cell – reprogramming the pluripotent cell stem cell IPS- IPS can be engineered to differentiate in cell cultures Example: Prof Melissa Little creating the 12 kidney cell types to form functional tissue engineering - Organova collaborated with professor Melissa Little for Kidney tissue research Junior Science Chemistry Biology Junior/intermediate engineering Anatomy and physiology Biomedical Design and Technology Tissue Engineering Biomedical Specialist Electives AMME5962 AMME5992 CHNG5602 CHNG5603 CHNG5604 CHNG5605 COMP5464 Case study 4. Myoelectric Control Robotic Limb Junior Science Maths

Chemistry Junior/intermediate Engineering Computing Mechanics Materials Electronics Anatomy and Physiology Senior Biomedical Engineering Biomedical design and technology Biomanufacturing Biomechanics Biomaterials Tissue engineering Biosignal Processing Biomedical Specialist electives MTRX5700 AMME5951 COMP5048 COMP5424 ELEC3305 ELEC5515 ELEC5614 ELEC5803

NOTES ON OTHER DEVICES - Pacemaker was invented in (1971) - Bionic Ear (1985) - Deep Brain Simulator (1997) - Bionic Eye (2012) - Bionic hand (2007) - Bionic Pancreas (2010) - Bionic Kidney (1997) - Thought-cancelled robotic arm (2012) - Thought cancelled Exoskeleton (2030) Bionics refer to Artificial intelligence Heart: 1. Pacemaker 2. Defibulator 3. Cardiac Pacemaker Sensory:

1. 2. Brain 1. 2.

Cochlear Bionic Ear Deep brain simulator Spinal Cord Simulator

Case Study 5 Bionic Eye: Laser printed technology Safe (platinum and sapphire) Feedthrough channels and pixels Models : 1. Argus 2 bionic eye (60 pixels) 2. 2012 bionic eye 1145 channels and (10,000) pixels require knowledge of the following 1. materials 2. biomedical design and technology 3. biomechanics 4. biomaterials Relevant specialist electives AMME5951 AMME5995 ELEC3305 ELEC5803

Lecture outline ▪ ▪ ▪ ▪ ▪ 1. 2. 3. 4. 5.

Engineering: an interdisciplinary heritage Engineering and innovation 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) Junior science Math Chem Bio Junior and intermediate Computing Mechanics Materials Electronics Anatomy and physiology Senior biomedical engineering Biomedical design and tech Biomanufacturing Biomechanics Biomaterias Tissue engineering Biosignal processing

AMME5951 AMME5995 ELEC3305 ELEC5803 MTRX5700 Creator of the bionic eye Dr Gaeme Clark (1961)

Pre-Tutorial Work: Week 3 Cassandra Soliman ‘Student ID: 470381225 Define the following terms and give examples of the clinicians/task involved. 1. Medical Practise (in clinics and Medical centres)

Medical practise involves the ability for the administration or exercise healthcare, the active practise of medicine can only be conducted by registered personnel according to the Medical Board of Australia. Medical practise is a significant implementation which also embodies direct clinical care available to any individual regardless of socioeconomic circumstance/ status. There is a plethora of different examples of medical practise they include the following: 1. Organisations or institutions that are separate entities that run limited to a patient base, these are operatable embracing unique medical facilitation relative to the specialisation 2. Group entities are one of the most common forms of medical practise which have a reasonably large patient network and is fashioned with more available clinical healthcare services these include (General practitioner’s clinic, optometrists, dental practises and other allied health professional establishments) 3. Another form of medical practise that is administrated in a clinical setting involves registered physicians operationally divided in a hospital trained in a particular specialisation for the purpose of implementing clinical care.

2. Allied Health Practise (in clinics and Hospitals)

Allied health practise is the complete separation from all practises involving clinical associative healthcare, however the individuals actively practising allied health involves the clear clinical research that aid diagnosis and preventative sources to assist ranges of conditions and illnesses. Examples of allied health practise: 1. Health science graduates 2. Research graduates etc

3. Clinical Practise (in Hospitals and day-surgeries) Clinical practise is defined as the development statements to assist members of the clinical realm such as practitioners and enables the active organisation of decision making appropriate to healthcare for specific circumstances.

Clinical practise embodies a support network for overall decision making process including the adherence to evidence based healthcare. Examples in healthcare and day surgeries include: 1. Bioinformatics sector in hospitals 2. An example of an organisation that Is known for handling health and disease management is the famous World Health Organisation. 4. Clinical Engineer A clinical engineer is a professional that specialises in providing advanced healthcare through the utilisation and implementation of technology and knowledge in a plethora of different disciplines such as medicine, engineering, and (science/mathematics) Clinical can engage with a range of different roles in healthcare they include: A. Orthopaedics ( clinical engineers manufacturing viable orthopaedic implants.) B. Maintenance off machinery utilised by physicians to treat and assess patients including CT scans, heart monitors etc.

Week 4 notes The two pillars of medical devices development 1. Safety 2. 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 1. ISO13485: Medical devices-Quality Management Systems A framework for Quality management systems which companies must set up if they want to manufacture medical devices (meet customer and regulatory requirement) 2. ISO13485:2016 (traceability) – Say what you going to do- Show how you have done this

“effective and efficient implementation of international standards can make the difference between life and death in the medical field”

ideas for medical devices come from: -

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